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Title: The effect of antidepressant treatment continuation in men and women with anxiety disorders: a prospective clinical study

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Abstract The human sexual response is a complex physiological process which involves different neural, paracrine, autocrine and endocrine mechanisms. Previous studies have revealed complex associations between sexual dysfunction, mood symptoms, and treatment with antidepressant drugs6. It has proven difficult to accurately identify the incidence of antidepressant treatment-emergent sexual dysfunction (encompassing both the worsening of pre-existing problems and the development of new sexual difficulties in previously untroubled patients). This study examines the effects of treatment persistence on sexual dysfunction in 35 patients with anxiety disorders (32 females, 12males). The study was conducted in a naturalistic setting and utilized well-validated measures. Cross-sectional findings indicated a point prevalence of sexual dysfunction of 57.1% at Baseline, 75.1% at Week 6 and 39.3% at Week 12. Longitudinal analysis found worsening of sexual function at Week 6, (but improvement in anxiety symptoms) and improvement of wellbeing and sexual function at Week 12. Sexual dysfunction was significantly positively correlated with the severity of anxiety symptoms, and significantly negatively correlated with mental wellbeing at Baseline, Week 6 and Week 12. Further research in this area is needed to confirm these preliminary results.
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Elnazer HY. Sexual dysfunction and anxiety treatment.
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Title: The effect of antidepressant treatment continuation in men and women with anxiety
disorders: a prospective clinical study.
Hesham Y Elnazer DM MBBCh MRCPsych 1, 2 (corresponding author)
ORCID 0000-0002-3508-684X
1. Sussex Partnership NHS Foundation Trust, Chichester, UK.
2. Brighton and Sussex Medical school, University of Sussex, UK.
Address for correspondence. Chapel Street Clinic, Chapel St, Chichester, PO19 1BX, UK. Tel: + 44 0300
304 0400; E-mail: elnazer@gmail.com
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Abstract
The human sexual response is a complex physiological process which involves different neural,
paracrine, autocrine and endocrine mechanisms. Previous studies have revealed complex associations
between sexual dysfunction, mood symptoms, and treatment with antidepressant drugs6.
It has proven difficult to accurately identify the incidence of antidepressant treatment-emergent
sexual dysfunction (encompassing both the worsening of pre-existing problems and the development
of new sexual difficulties in previously untroubled patients).
This study examines the effects of treatment persistence on sexual dysfunction in 35 patients with
anxiety disorders (32 females, 12males). The study was conducted in a naturalistic setting and utilized
well-validated measures.
Cross-sectional findings indicated a point prevalence of sexual dysfunction of 57.1% at Baseline, 75.1%
at Week 6 and 39.3% at Week 12. Longitudinal analysis found worsening of sexual function at Week
6, (but improvement in anxiety symptoms) and improvement of wellbeing and sexual function at
Week 12. Sexual dysfunction was significantly positively correlated with the severity of anxiety
symptoms, and significantly negatively correlated with mental wellbeing at Baseline, Week 6 and
Week 12. Further research in this area is needed to confirm these preliminary results.
(183 words)
Key words: sexual dysfunction, anxiety, , treatment persistence.
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INTRODUCTION
The human sexual response is a complex physiological process. The widely accepted five stage sexual
response model (Masters & Johnson and Lief model) 1,2 involves different neural, paracrine, autocrine
and endocrine mechanisms. It is proposed that libido is stimulated by dopamine 3, inhibited by
serotonin, and threshold-adjusted by androgens 3. Arousal and the plateau phase are respectively
triggered and maintained by parasympathetic signals. Both central and peripheral regulation of penile
erection/ vaginal lubrication involves several neurotransmitters and systems. Orgasm is related to
sympathetic neurons, and resolution represents a return to the base phase, during which different
molecular mechanisms are involved both centrally and peripherally to facilitate detumescence 5,6. The
most common sexual dysfunction in men are erectile dysfunction, affecting Between 10% 7 and 16% 8
and premature ejaculation, which affects 14% of men 7 of men. The most common sexual dysfunction
in women is hypoactive sexual desire disorder with a prevalence of 16%-46% 9.
Recognition rates of sexual dysfunction in primary medical care are low 10,11,12. Lack of communication
of sexual difficulties was reported in 50-73% of patients with enduring mental illnesses 13. This was
also found to be more pronounced in females (80%) 4. Relying on spontaneous reporting of sexual
dysfunction could-potentially- mislead the clinician to assume the lack of sexual difficulties.
Assessment of sexual dysfunction can be challenging in practice, partly because differing assessment
methods lead to variable results. For example, an investigation found the prevalence of sexual
dysfunction in men to be 20% if reliant on spontaneous report by the patient, but 60% on direct
enquiry 15. Physicians may believe that affected patients would spontaneously report sexual
difficulties 16, but less than 20% patients who suffer from sexual dysfunction spontaneously report
problems or seek help 17: ‘embarrassment’ appears to be the main reason for not reporting 18. The
most reliable approach to assessing the prevalence and nature of sexual difficulties is a
comprehensive, integrated interview that considers multiple dimensions of sexual life (individual,
relational, medical, erotic, sexual skill, and situational dimensions) 19, but this is time-consuming and
often not feasible in practice.
Use of screening questionnaires may be valuable in busy clinical settings. Existing scales fall into
different categories: general measures of sexual dysfunction, measures of sexual dysfunction in
depressed populations, and female- and male- specific scales 20. Use of clinician-administered
schedules may increase validity, but self-reporting scales have better reliability, possibly due to the
sensitivity of the subject. Screening tools for sexual dysfunction with fewer items are more prone to
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false positive than false negatives, whereas questionnaires with more items have a better ability to
examine specific domains of sexual function 20.
Sexual dysfunction and anxiety
Symptoms of depression commonly co-exist with symptoms of anxiety which are associated with
sexual dysfunction 21,22. Mood disorders typically follow a chronic, waning and remitting course. The
presence of 12 months’ mood disorders was found to have a significant association with poor sexual
satisfaction 23. Pharmacological management of anxiety disorders typically utilises antidepressants as
first line of treatment 24. Sexual difficulties are commonly reported adverse effects of antidepressant
medications 25. Their estimated prevalence depends on the utilised method of data collection, with a
low prevalence when relying on spontaneous reports and higher proportions when using confidential
questioning or questionnaires 26. Antidepressants can cause sexual dysfunction by disturbing
cholinergic/adrenergic balance, antagonism of peripheral alpha-2 adrenoceptors, inhibition of nitric
oxide and increased serotonergic availability 27. Some studies also reported increased levels of
prolactin associated with antidepressants treatment 28,29. An animal study found serotonin reuptake
inhibitors (SSRI)-mediated sexual dysfunction to be due to reduced nitrous oxide (NOS) via increasing
nicotinamide adenine dinucleotide phosphate oxidase activity 30. Other mechanisms may also be
involved in erectile dysfunction associated with SSRI, central sensitisation of 5HT receptors can
produce an inhibitory effect on the parasympathetic system. Peripherally, increasing available
serotonin through inhibiting reuptake in the platelets can produce vasoconstriction at the cavernous
bed, via 5HT1B, 5HT1D, and the non-receptor mechanism of serotonylation, therefore leading to
erectile dysfunction 31.
The common phenomenon of sexual dysfunction associated with antidepressant treatment 25
smuggest some overlap in mechanisms underlying response to antidepressant treatment with
mechanisms underlying sexual functioning. Also, affective symptoms were reported to reduce
compliance with pharmacological treatment of sexual dysfunction. It has proven difficult to accurately
identify the incidence of antidepressant treatment-emergent sexual dysfunction (encompassing both
the worsening of pre-existing problems and the development of new sexual difficulties in previously
untroubled patients) 32. However, studies of the prevalence of sexual dysfunction in patients who were
prescribed either on SSRI or serotonin-noradrenaline reuptake inhibitor (SNRI) indicated that between
27 and 65% of female patients and 26 and 57% of male patients experienced either a worsening of
pre-existing difficulties or the emergence of new sexual difficulties in the early weeks of treatment
33,34. It is worth noting that some antidepressants can have a therapeutic effect in some patients with
sexual dysfunction. Patients with persistent premature ejaculation can benefit from treatment with
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either clomipramine or SSRIs 35. A daily, or on-demand dose, of dapoxetine was found to be beneficial
36. High daily doses of paroxetine (150-200 mg), were also found beneficial in treating psychogenic
erectile dysfunction 37.
A meta-analysis (of studies with different designs, n=14) found that treatment emergent sexual
dysfunction was not more common than with placebo for the antidepressants agomelatine,
amineptine, bupropion, moclobemide, mirtazapine or nefazodone: by contrast, other antidepressants
had significantly more negative impact than placebo, affecting all phases of sexual function. The study
found sexual dysfunction was associated with the following antidepressants, in decreasing order of
impact: sertraline, venlafaxine, citalopram, paroxetine, fluoxetine, imipramine, phenelzine,
duloxetine, escitalopram, and fluvoxamine, with sexual dysfunction rates ranging from 25.8% to 80.3%
38. A more recent meta-analysis (n= 58 randomised controlled trials and 5 observational studies) found
relative disadvantages for paroxetine and venlafaxine, and relative advantages for bupropion, but
there were only minor differences between antidepressants 39. The relationship between anxiety
disorders, sexual dysfunction and dissatisfaction has not been explored extensively. Little is known
about the prevalence of sexual dysfunction in patients with anxiety disorders, or its association with
demographic and other clinical factors 40.
Management of sexual dysfunction in mood disorders
Commonly adopted approaches include: dose reduction, drug holiday, switching of antidepressants
have been instigated only modestly 641. risk of symptomatic relapse and discontinuation symptoms 42.
Adjuvant treatments have little supporting evidence from placebo-controlled investigations. Some
studies have found some benefits with bupropion, olanzapine 43, topical testosterone gel 65 and
aripiprazole 45. Phosphodiesterase 5 (PDE-5) inhibitors were found to be efficacious (for both males
and females) in resolving sexual dysfunction with antidepressants 46,47. The effect of antidepressants
persistence on sexual dysfunction continues to be unclear.
METHODS
Ethics
This project received the required ethical approvals from Hampshire Research Ethics Committee (REC
reference:16/SC/0038); UK Health Research Authority (HRA) (IRAS project ID: 170365); and Medicinal
Health Research Authority (MHRA) (EudraCT number:2016-000337-48).
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Recruitment and assessments
Details of the recruitment process were published somewhere else 48. Recruited patients (age 20-60
years) had the primary diagnosis of an anxiety disorder or anxiety-related disorder, defined according
to Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria (American
Psychiatric Association 2013) 49, and were competent to provide written consent. Patients were
excluded from the study if they were: did not have a primary diagnosis of an anxiety disorder, unable
to provide written, informed consent, have a clinically significant alcohol or substance use in the
previous three months, pregnancy and breast feeding, diagnosed with any acute physical health
condition or have been prescribed medication which is deemed to influence sexual function (beta
adrenoreceptor antagonists, centrally-acting alpha agonists, diuretics, alpha adrenergic drugs,
angiotensin II receptor antagonist) 50.
Assessment tools
Patients were assessed using the Arizona Sexual Dysfunction Scale 51, Hospital Anxiety and Depression
Scale (HADS) 52, Clinical Global Impression of Illness Severity (CGI-S) 53, Warwick-Edinburgh Mental
Well-Being Scale (WEMWEBS) 54 and Emotional Quality of the Relationship Scale (EQR) and Sexual
Activity and Satisfaction Scales (SAS) 55 and Oxford Questionnaire of Emotional Side Effects of
Antidepressants (OQuESA) 56, at Baseline (Week 0), after 6 weeks of being stabilised on their usual
treatments (Week 6), and assessments were repeated after further 6 weeks (at Week 12). Treatment
adherence was determined by patient report and tablet count. Blood samples were collected from
participants (with their consent) for prolactin levels analysis at Baseline (Week 0), Week 6 and Week
12.
The Arizona Sexual Dysfunction Scale (ASEX)
This comprises five items, which quantify sex drive, arousal, vaginal lubrication/penile erection, ability
to reach orgasm, and satisfaction from orgasm. It has well-documented reliability and validity, is
concise, and easy to administer in clinical settings 57. Possible total scores range from 5 to 30, higher
scores indicating greater sexual dysfunction. ASEX designates ‘sexual dysfunction’, with a total score
of 19 or more; any single item with a score of 5 or more; or any three items with a score of 4 or more
51. The ASEX has been used in many cross-sectional prevalence studies and in randomised controlled
trials of pharmacological treatment, but there is some uncertainty about its utility in other clinical
settings. The ASEX scale appears to have excellent internal consistency and scale reliability and strong
testretest reliability. Furthermore, ASEX scores appear to correlate well with factors and related
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items on other validated questionnaires for assessing sexual dysfunction. ASEX has very high
sensitivity and specificity, and very high positive and negative predictive values.
Warwick-Edinburgh Mental Well-Being Scale (WEMWBS)
This was developed to enable monitoring of mental wellbeing in the general population and the
evaluation of projects, programmes and policies which aim to improve mental wellbeing. WEMWBS is
a 14-item scale with 5 response categories, summed to provide a single score ranging from 14-70.
National survey reports have been published by Warwick medical school, and they show population
norms for England 2011 (https://warwick.ac.uk/fac/sci/med/research/platform
/wemwbs/researchers/interpretations/wemwbs_population_norms_in_health_survey_for_england
_data_2011.pdf). The items are all worded positively and cover both feeling and functioning aspects
of mental wellbeing. The scale has good content validity and a Cronbach’s α of 0.91. WEMWBS has a
high correlation with mental health and well-being but lower correlations with overall health. Its
distribution is near normal and the scale did not show ceiling effects. It discriminated between
population groups in a way that is largely consistent with the results of other population surveys. Test-
retest reliability at one week was high (0.83). Social desirability bias was lower or similar to that of
other comparable scales 53.
Hospital Anxiety and Depression Scale (HADS)
This questionnaire comprises seven questions for anxiety and seven questions for depression. Anxiety
and depression questions are interspersed within the questionnaire; these are scored separately. Each
item has a possible score of 0-3. A total score of 8-10 indicates a borderline case and a score of 11-21
indicates a probable case 52.
The mean correlations between HADS-A and HADS-D is 0.56. The mean Cronbach’s α for HADS-A is
0.83 and 0.82 for HADS-D. An optimal balance between sensitivity and specificity was achieved when
caseness was defined by a score of 8 or above on both HADS-A and HADS-D. The sensitivity and
specificity for both HADS-A and HADS-D of approximately 0.80 are very similar to the sensitivity and
specificity achieved by the General Health Questionnaire (GHQ-28). Correlations between HADS and:
BDI; GHQ-28; Clinical Anxiety Scale (SCI); Spielberger’s State-Trait Anxiety Inventory (STAI); Symptom
Checklist (SCL-90) and subscales of Anxiety and Depression Montgomery Asberg Depression Rating
Scale, were in the range 0.49 to 0.83 58.
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Clinical Global Impression (CGI)
This is an assessment of the clinician's view of the patient's global functioning prior to and after
initiating a treatment. It provides an overall clinician-determined summary measure that considers all
available information, including a knowledge of the patient's history, psychosocial circumstances,
symptoms, behaviour, and the impact of the symptoms on the patient's ability to function. The CGI
comprises two parts; one item measures the severity of psychopathology (CGI-S) and the second
measures change from the initiation of treatment (CGI-I). Each domain has a possible score of 1-7 54.
CGI ratings are positively correlated with self-reported and clinician-administered measures in
patients with social anxiety. The CGI-I was found to be highly correlated (r=0.71), with measures of
change from Health of the Nation Outcomes Scales (HONOS), the Michigan Hand Outcomes
Questionnaire (MHQ) and Depression Anxiety Stress Scales (DASS-2) 84. The limitations of this simple
and short scale are poor distribution properties, and a presumably restricted significance of change
ratings has been recognised 59.
Emotional Quality of the Relationship Scale (EQR)
This measures affection, emotional intimacy, communication and satisfaction with these areas of the
relationship as a whole. It has 7 sub-domains and items are scored on a four-point ordinal scale ranging
from 4 (very great) to 1 (very poor). Scores are summed resulting in a composite score that ranges
from a minimum score of 7 to a maximum of 28. Higher scores indicate that the emotional quality of
the relationship is stronger 55. Internal consistency of the EQR is High (α=0.85). The EQR is significantly
(p<0.01) and moderately correlated with the: Sexual Behaviour Scale (r=0.45); Hospital Anxiety and
Depression Scale (HADS) (r=-0.38) and the Quality of Life Visual Analog Scale (r=0.37). No cut-points
or normative data have been established 55.
Sexual Activity and Satisfaction Scales (SAS)
This is a sub-scale of the EQRS which was developed by Kreuter at al., 1996 to investigate sexual
activity and satisfaction for patients with spinal injury and their partners. The first item investigates
the frequency of sexual activity, with or without intercourse, which is scored on the scale of 1-8; the
second and third items investigate sexual satisfaction and satisfaction of the relationship as a whole,
each is scored on the scale of 1-4. Higher scores indicate greater sexual activity and satisfaction.
Internal consistency is high for the SAS scale (Cronbach’s α=0.87). In patients with spinal injury, SAS
was found to be correlated with, EQRS r=0.57. No cut-points or normative data have been established
55.
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Oxford Questionnaire of Emotional Side Effects of Antidepressants (OQuESA)
This was developed to measure emotional symptoms present in patients treated with antidepressants
56. It has 26 items; each has a possible scored of 1-5. OQuESA items are sub-classified into four
dimensions: not caring (NC), emotional detachment (ED), reduction in positive emotions (RP), and
general reduction in emotions (GR). A further attributional dimension can be scored: antidepressant
as cause (AC). RP and NC may be closely related to the phenomenon of depression as well as to the
phenomenon of antidepressant-associated emotional blunting, whereas the two remaining
dimensions (GR & ED) are less closely related to depression. For participants whose gold standard
response increased by one or more, the mean increase in OQuESA total score was 2.81, but this did
not reach statistical significance (mean increase 2.81, 95% Cis 5.72 to −0.99, t=1.96, df=36, p= 0.058.
For participants whose gold standard response did not change, the total score increased by 0.980,
which was not statistically significant (mean increase 0.980, 95% Cis −1.06 to 3.01, t=0.956, df=98,
p=0.342) 56.
Enzyme-linked immunosorbent assay for serum prolactin levels
An 8-10ml sample of venous blood was collected by venepuncture into a serum separator tube (SST)
vacutainer (gold top, with gel as a separator) under sterile conditions by trainer staff and as per the
National Health Service (NHS) standards. Blood samples were sent to the University Hospital of
Southampton pathology laboratory for analysis. The sample was obtained from blood cells and serum
supernatant after centrifugation (1750 g for 10 minutes). A human prolactin standard is provided to
generate a standard curve for the Enzyme-linked immunosorbent assay (ELISA). We used the
commercially available kit from R&D system (Minneapolis, MN, USA). The kit has a reported high
sensitivity and excellent specificity for detection of human Prolactin. No significant cross-reactivity or
interference between human Prolactin and analogues was observed. The kit manufacturer reported a
standard curve range of 15.6-1000 pg/ml, sensitivity of 12.5 pg/ml, inter-assay coefficients of
variability (CV%) of <10% and Intra Assay CV of <8%. Standards or diluted samples (10% bovine serum
albumin (BSA)); were pipetted into a clear microtiter plate coated with a monoclonal antibody to
capture the prolactin present. After a 2 hours’ incubation, the plate is washed (with 25X concentrated
solution of buffered surfactant with preservative), and a peroxidase-conjugated prolactin polyclonal
antibody is added. The plate is again incubated for 2 hours and washed (4 times). 200 µL of Anti-G
substrate (stabilized tetramethylbenzidine) is then added to the plate, which reacts with the bound
prolactin antibody conjugate. After a third, 30 min, incubation, the reaction is stopped by adding 50
µL of the stop solution (2N sulphuric acid), and the intensity of the generated colour is detected in a
microtiter plate reader capable of measuring at 450 nm.
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DATA ANALYSIS
As per protocol, participants underwent tests at Baseline (before treatment), 6 weeks and 12 weeks
of treatment. Some participants preferred not to provide answers to some questionnaires at Baseline,
but collaborated on other tests. Data were analysed using IBM SPSS® Statistics 26.0.
RESULTS
Some potential participants dropped out following the initial explanation of the study (53 males [39%],
82 females [61%]: mean age, 34 years). The attrition rate from expressing interest in taking part to
providing an informed consent was 76%. Reasons for dropping out were as follows: feeling too unwell
to take part in the study (22% [too anxious 21%, too depressed 1%]); concerns about time
commitments (15%); the lack of financial compensation/reward (14%); not feeling comfortable talking
about sexual life (10%); and no reason given (39%).
Thirty-five participants consented to take part in this study. 12 (35%) were males and 23 (65%) were
females (mean age 32.46 years, standard error of mean [SEM] 2.175) (Table 1). All participants had
English as their first language: 29 were white British, four Asian British, and one black British. Twenty
participants (57%) were professionally active at the time of enrolment; and 25 participants (71%)
reported being in a stable relationship at the time of enrolment. Nineteen participants (54.3%) were
within the range of healthy body mass index (BMI) (18.5-24.9) but 13 (37.1%) were overweight and 3
(8.6%) were underweight. Participants received six weeks of ‘treatment as usual’, from their usual
clinician. At Week 6, nineteen patients (57.7%) had undergone treatment with an SSRI; six patients
(18.3%) with an SNRI; three patients with a noradrenergic and specific serotonergic antidepressant
(NASSA) (9%); two patients (6%) with cognitive behavioural therapy (CBT); and a single patient with a
β-Blocker (3%): two patients (6%) had not undergone any treatment by the Week 6 review. And
undergone further six weeks of treatment (n=27) by Week 12.
ASEX performance properties
ASEX reliability analysis found statistically significant mean inter-item correlations (Table 3) at Baseline
(Week 0) (0.757, minimum 0.655, maximum 0.877, range 0.222 variance 0.004); at Week 6 (0.548,
minimum 0.3, maximum 0.745, range 0.445 variance 0.016); and at Week 12 (0.741, minimum 0.642,
maximum 0.798, range 0.155 variance 0.003). Cronbach’s α was 0.939 at Baseline (Week 0); 0.853 at
Week 6 and 0.934 at Week 12. Factor analysis found a relatively larger Eigen value for the first ASEX
item (sexual desire) (Table 2).
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Pre-treatment/Baseline findings
The mean scores and SEM on rating scales at Baseline (Week 0) were as follows: WEMWBS 27 (SEM
1.81); HADS-A 15.42 (SEM 0.88); HADS-D 13 (SEM 0.82); EQRS 18.4 (SEM 1.04); SAS 7.88 (SEM 0.58);
CGI-S 4.56 (SEM 0.22). OQUESA-GR 15.5 (SEM 1.17); OQUESA-RP 22.18 (SEM 0.75); OQUESA-ED 15.09
(SEM 3.17) and OQUESA-NC 18 (SEM 1.27).
The ASEX total mean score for male participants (n=12) at Baseline (Week 0) was 14.17 (SEM 2.25).
ASEX item mean scores were as follows: item 1 (sex drive), 3.8 (SEM 0.56); item 2 (arousal), 3.8 (SEM
0.56); item 3 (erection), 2.75 (SEM 0.48); item 4 (ability to reach orgasm), 2.58 (SEM 0.4) and item 5
(orgasm satisfaction), 2.67 (SEM 0.48). The ASEX total mean score for female participants (n=23) at
Baseline (Week 0) was 19.09 (SEM 1.33). ASEX item mean scores were as follows: item 1 (sex drive),
3.83 (SEM 0.3); item 2 (arousal), 3.83 (SEM 0.3); item 3 (vaginal lubrication), 3.7 (SEM 0.33); item 4
(ability to reach orgasm), 4.17 (SEM 0.26) and item 5 (orgasm satisfaction), 3.78 (SEM 0.33).
Categorisation of sexual dysfunction in the study sample using ASEX criteria identified 20 participants
(57.1%) with sexual dysfunction: 5 (25%) males and 15 (75%) females. The 15 participants who were
not classified as having sexual dysfunction were more balanced in gender (7 males [46.7%], 8 females
[53.3%]).
Canonical multivariate correlation analysis of multiple-X multiple-Y correlation found a statistically
significant correlation between ASEX total mean score and CGI-S mean score (p=0.048), HADS-D mean
score (p=0.01) and a statistically significant inverse correlation with WEMWBS mean score (p=0.00),
SAS mean score (p=0.01). These correlations remained statistically significant after adjusting for age
and gender, using logistic regression partial correlation. After further adjustment for EQRS and SAS,
ASEX total mean score had statistically significant correlations with HADS-D mean score (p=0.00). After
further adjustment for EQRS and SAS, ASEX total mean score had statistically significant correlations
with HADS-D mean score (p=0.00) and with OQUESA-ED (p=0.00). After further adjustment for HADS-
D, no statically significant correlations between ASEX and any of the tested parameters were found.
Effects of 6 weeks of treatment
By Week 6, thirty-three participants received six weeks of ‘treatment as usual’, from their usual
clinician. The mean psychometric scores at Week 6 were as follows: WEMWBS 33.30 (SEM 1.75);
HADS-A 13.70 (SEM 0.73); HADS-D 10.82 (SEM 0.68); EQRS 20.08 (SEM 0.93); SAS 7.77 (SEM 0.59);
CGI-S 4.27 (SEM 0.23); CGI-I 2.69 (SEM 0.16); OQUESA-GR 16.30 (SEM 0.75); OQUESA-RP 18.97 (SEM
0.95); OQUESA-ED 11.06 (SEM 0.87); OQUESA-NC 16.10 (SEM 0.86); and OQUESA-AC 14.48 (SEM
1.25). The mean scores of HADS-A and HADS-D decreased from Baseline (Week 0) to Week 6. Paired
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sample t test found non-statistically significant changes in mean psychometric scores for anxiety
symptoms (HADS-A) (p=0.069) and depression symptoms (HADS-D) (p=0.338).
The mean ASEX total score for male participants (n=11) at Week 6 was 18.27 (SEM 1.73). ASEX sub-
item scores were as follows: Item 1 (sex drive) 4.27 (SEM 0.36); Item 2 (arousal) 3.64 (SEM 0.34); Item
3, (erection) 2.91 (SEM 0.27); Item 4 (ability to reach orgasm) 4.18 (SEM 0.46) and Item 5 (orgasm
satisfaction) 3.64 (SEM 0.54).
The mean ASEX total score for female participants (n=22) at Week 6 was 21.14 (SEM 1.12). ASEX sub-
item scores were as follows: Item 1 (sex drive) 4.64 (SEM 0.28); Item 2 (arousal) 4.09 (SEM 0.28); Item
3, (vaginal lubrication) 3.73 (SEM 0.31); Item 4 (ability to reach orgasm) 4.55 (SEM 0.24) and Item 5
(orgasm satisfaction) 4.14 (SEM 0.32).
At Week 6, 75.1% of the participants were found to have sexual dysfunction (as defined by ASEX
criteria), compared to 57.1% at Baseline (Week 0). Canonical multivariate correlation analysis of
multiple-X multiple-Y between ASEX scores at Baseline (Week 0) and Week 6 found statistically
significant correlations for the mean scores of ASEX-total (p=0.02), Item 2 (arousal) (p=0.01) and Item
4 (ability to reach orgasm) (p=0.00). Pearson’s correlation analysis found that ASEX total score at Week
6 was positively and significantly correlated with ASEX-total score at Baseline (Week 0) (r=0.407,
p=0.019). Regression found a positive predictability of ASEX total score at Week 6 from ASEX total
score at Baseline (Week 0).
ASEX total mean score increased from Baseline (Week 0) to Week 6, with a mean change 3.15 (SEM
1.22, p=0.01). Some ASEX item scores changed significantly from Baseline (Week 0) to Week 6: Item 1
(sexual drive) 1.061 (SEM 0.298, p=0.001) and Item 4 (ability to reach orgasm) 0.82 (SEM 0.28, p=0.01).
The changes in other items were non-significant: Item 2 (arousal) 0.45 (SEM 0.26, p=0.10); Item 3
(erection/vaginal lubrication) 0.18 (SEM 0.25, p=0.47); Item 5 (orgasm satisfaction) 0.64 (SEM 0.34,
p=0.07). Analysis by gender found a statistically significant increase in mean scores for female
participants: ASEX total score 2.23 SEM 1.09 (p=0.03) and Item 4 (ability to reach orgasm) 2.215 SEM
0.2 (p=0.04).
Effect of twelve weeks of treatment persistence
By Week 12 testing, twenty-seven patient participants had received further six weeks of treatment as
The mean psychometric scores at Week 12 were as follows: WEMWBS 39.85 (SEM 2.691); HADS-A
11.37 (SEM .968); HADS-D 8.52 (SEM .826); EQRS 20.95 (SEM 1.014); SAS 8.32 (SEM .599); CGI-S 3.26
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(SEM .211); CGI-I 2.43 (SEM .249); OQUESA-GR 14.84 (SEM 1.061); OQUESA-RP 15.54 (SEM 1.112);
OQUESA-ED 10.38 (SEM .967); OQUESA-NC 14.58 (SEM 1.126); and OQUESA-AC 11.57 (SEM 1.110).
The mean ASEX total score at Week 12 for male participants (n=9) was 16.89 (SEM 2.42). ASEX item
scores were as follows: Item 1 (sex drive) 3.67 (SEM 0.62); Item 2 (arousal) 3.11 (SEM 0.51); Item 3,
(erection) 3.22 (SEM 0.57); Item 4 (ability to reach orgasm) 4 (SEM 0.58) and Item 5 (orgasm
satisfaction) 3.22 (SEM 0.68). The mean ASEX total score at Week 12 for female participants (n=18)
was 17.44 (SEM 1.45). ASEX item scores were as follows: Item 1 (sex drive) 3.78 (SEM 0.33); Item 2
(arousal) 3.44 (SEM 0.37); Item 3, (vaginal lubrication) 3.39 (SEM 0.34); Item 4 (ability to reach orgasm)
3.53 (SEM 0.3) and Item 5 (orgasm satisfaction) 3.33 (SEM 0.3).
At Week 12 39.3% of the participants were found to have sexual dysfunction (as defined by ASEX
criteria), compared to: 75.1% at Week 6 and 57.1% at Baseline (Week 0).
Canonical multivariate correlation analysis of multiple-X multiple-Y correlation found statistically
significant correlation between ASEX total mean score and: HADS-A total mean score (p=0.042); SAS
total mean score (p<0.0001); CGI-S total mean score (p=0.001) and OQUESA-RP total mean score
(p=0.002). Adjusting for age, ASEX total mean score continued to be correlated with SAS total mean
score (p=0.01).
ASEX mean scores decreased from Week 6 to Week 12 with a change in ASEX 2.44 (SEM 1.22, p=0.01).
Paired t-sample test found statistically significant decrease from Week 6 in item 1 (sexual drive) 2.94
(p=0.07); item 2 (arousal) 2.56 (p=0.017) and item 4 (ability to reach orgasm) 3.06 (p=0.005). Analysis
by gender found a statistically significant decrease in female participants with a change in: Item 1
(sexual drive) 2.27 SEM 0.27 (p=03), Item 5 (orgasm satisfaction) 2.15 SEM 0.26 (p=0.046), ASEX total
2.77 SEM 0.0 (p=0.1). Paired sample correlations for ASEX scores at Baseline (Week 0), Week 6 and
Week 12, found ASEX scores were significantly correlated in female participants, except for Item 5
(orgasm satisfaction) Table (3).
Prolactin levels
ELISA plasma prolactin, found within normal range (57.5-276 mu/L for males and 57.5-561 mu/L for
females) concentrations at: Baseline (Week 0) (male [n=1], female [n=6]); Week 6 (male [n=8], female
[n=18]) and Week 12 (male [n=6], female [n=16]) Table 8. Paired t test analyses found changes in mean
plasma prolactin concentrations from Baseline (Week 0) to Week 6 and to Week 12, did not meet
statistical significance.
Elnazer HY. Sexual dysfunction and anxiety treatment.
14
Discussion
Through the course of this study, ASEX was administered 92 times. Analysis of psychometric properties
indicated high internal consistency and high reliability in this patient group. Factor analysis found item
1 (sexual desire) accounts for 64%-80.6% of variance, which suggests that the scale items are
unidimensional. This might be because the sexual response is a sequential process triggered by the
initiation step of sexual desire. ASEX criteria of sexual dysfunction as, total score of 19 (criteria 1) or
more was fulfilled 13 times; any single item with a score of 5 (criteria 2) or more was fulfilled 12 times
and any three items with a score of 4 (criteria 3) or more was fulfilled 13 times. Ten patients met more
than one ASEX criterion of sexual dysfunction. Criteria 1 and 2 combined were met 11 times; criteria
1, 2 and 3 combined were fulfilled 11 times; criteria 2 and 3 combined were fulfilled 11 times; and
criteria 3 and 1 combined were fulfilled 12 times. Most patients with sexual dysfunction met more
than one ASEX criterion at every time point. The study found that at each time point, each participant
with sexual dysfunction moved between different ASEX-defined sexual dysfunction criteria.
More than half patient participants struggled with sexual dysfunction at Baseline (57%). The severity
of sexual dysfunction (ASEX) was correlated with the severity of anxiety illness (CGI-S) and was
inversely correlated with well-being (WEMWBS), regardless of age or gender. Sexual dysfunction
(ASEX) was found to be correlated with emotional detachment (OQUESA-ED) (after adjusting for
emotional quality of relationship [EQRS]). This might suggest a two-way relationship between sexual
function and well-being; severity of anxiety and emotional detachment.
Participants continued to be troubled by significant anxiety symptoms at Week 6, although less than
at Baseline (HADS-A). Patient quality of life improved from Baseline to Week 6 (WEMWBS). This study
found worsened sexual function (ASEX) at Week 6 and positive predictability of ASEX total score at
Week 6 from ASEX total score at Baseline (ASEX-total post treatment Week 6 = 0.316 × [ASEX-total at
Baseline] + 14.807). overall sexual function and ability to reach orgasm were particularly worse in
female patients after 6 weeks of treatment.
At Week 12, there was improved sexual function (ASEX) and severity of anxiety symptom (CGI-S).
Improved overall sexual function, sexual drive and orgasm satisfaction, were more statistically
significant in female patients.
These findings suggest that in patients with a diagnosis of anxiety disorders at Baseline, there was a
significant correlation between sexual dysfunction (ASEX scores) and depressive symptoms (HADS-D)
and with emotional detachment (OQUESA-ED). This continued to be statistically significant after
Elnazer HY. Sexual dysfunction and anxiety treatment.
15
adjusting for age, gender, and quality of relationship. The findings suggest no statistically significant
correlation between anxiety symptoms (HADS-A) and ASEX scores. The small sample number did not
allow further sub-analysis. Further research in this area to include demographic and clinical factors is
essential to identify implicated mechanisms of emergent sexual dysfunction. A possible implicated
mechanism is through the arachidonic acid pathway. There is evidence that the SSRI citalopram
attenuates the release of thromboxane A2 42. This would lead to a loss of negative feedback on the
limb of the pathway and subsequently to decreased production of prostaglandins peripherally. This
proposed model suggests a potential for identifying new targets for treating sexual dysfunction and
for better understanding of different pathogenesis pathways of anxiety disorders. For example, if it is
the case that erectile dysfunction associated with SSRI is due to a peripheral mechanism increasing
serotonin release from platelets, a trial of metergoline (a 5-HT antagonist) could potentially reverse
the process.
CONCLUSION
This study shows that patients with anxiety disorders who suffer sexual dysfunction are likely to
struggle with dysfunction in more than one sexual domain. Findings suggests initial improvement in
anxiety symptoms but worsened sexual function with 6 weeks of treatment. Persistence with
treatment for 12 weeks resulted further improvement in anxiety symptoms and improvement of
sexual function (particularly in female patients).
Sexual dysfunction was correlated with the severity of anxiety symptoms and inversely correlated with
mental wellbeing. Clinicians might educate patients regarding their course of treatment and what they
might expect. Investigating sexual dysfunction in this patient group, as an integral part of overall
clinical assessment, can provide the patient with a better opportunity for effective management of
their anxiety symptoms; sexual function and enhancing their overall wellbeing.
Elnazer HY. Sexual dysfunction and anxiety treatment.
16
Authors Contributions
The authors meet the criteria of authorship described by The International Committee of Medical
Journal Editors (ICMJE).
Financial support
This research received no specific grant from any funding agency, commercial or not-for-profit sectors.
Statement of interest
None.
Ethical standards
The authors assert that all procedures contributing to this work comply with the ethical standards of
the relevant national and institutional committees on human experimentation and with the Helsinki
Declaration of 1975, as revised in 2008.
Financial support
This research received no specific grant from any funding agency, commercial or not-for-profit sectors.
Acknowledgement
The author acknowledges the guidance and support during his doctorate studies from Professor David
Baldwin and Professor Antony Sampson (University of Southampton, UK).
Elnazer HY. Sexual dysfunction and anxiety treatment.
17
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23
Table 1 Participants demographics
Gender
Mean
N
Std.
Deviation
Std. Error of
Mean
Range
Maximum
Variance
Male
38.6667
12
11.46008
3.30824
32.00
56.00
131.333
Female
29.2174
23
12.58410
2.62397
40.00
60.00
158.360
Total
32.4571
35
12.87118
2.17563
40.00
60.00
165.667
Elnazer HY. Sexual dysfunction and anxiety treatment.
24
Table 2 ASEX total variance analysis
Baseline
Component
Initial Eigenvalues
Extraction Sums of Squared Loadings
Total
% of Variance
Cumulative %
Total
% of Variance
Cumulative %
1
4.029
80.579
80.579
4.029
80.579
80.579
2
.472
9.440
90.019
3
.223
4.465
94.484
4
.175
3.494
97.978
5
.101
2.022
100.000
Extraction Method: Principal Component Analysis.
Week 6
Component
Initial Eigenvalues
Extraction Sums of Squared Loadings
Total
% of Variance
Cumulative %
Total
% of Variance
Cumulative %
1
3.200
63.993
63.993
3.200
63.993
63.993
2
.865
17.297
81.290
3
.457
9.146
90.436
4
.262
5.232
95.668
5
.217
4.332
100.000
Extraction Method: Principal Component Analysis.
Week 12
Component
Initial Eigenvalues
Extraction Sums of Squared Loadings
Total
% of Variance
Cumulative %
Total
% of Variance
Cumulative %
1
3.965
79.305
79.305
3.965
79.305
79.305
2
.421
8.430
87.735
3
.250
4.995
92.730
4
.212
4.242
96.972
5
.151
3.028
100.000
Extraction Method: Principal Component Analysis.
Elnazer HY. Sexual dysfunction and anxiety treatment.
25
Table 3 ASEX scores paired samples correlations
Females
Males
N
Correlation
Sig.
N
Correlation
Sig.
Pair 1
ASEX-1 W0 & ASEX-1 W6
22
.472
.026
11
-.032
.926
Pair 2
ASEX-1 W6 & ASEX-1 W12
18
.649
.004
9
.721
.028
Pair 3
ASEX-2 W0 & ASEX-2 W6
22
.646
.001
11
.134
.695
Pair 4
ASEX-2 W6 & ASEX-2 W12
18
.784
.000
9
.624
.072
Pair 5
ASEX-3 W0 & ASEX-3 W6
22
.704
.000
11
.276
.412
Pair 6
ASEX-3 W6 & ASEX-3 W12
18
.666
.003
9
.557
.119
Pair 7
ASEX-4 W0 & ASEX-4 W6
22
.664
.001
11
-.239
.479
Pair 8
ASEX-4 W6 & ASEX-4 W12
17
.774
.000
9
.409
.275
Pair 9
ASEX-5 W0 & ASEX-5 W6
22
.398
.067
11
-.014
.966
Pair 10
ASEX-5 W6 & ASEX-5 W12
18
.672
.002
9
.321
.400
Pair 11
ASEX-Total W0 & ASEX-Total
W6
22
.603
.003
11
-.001
.998
Pair 12
ASEX-Total W6 & ASEX-Total
W12
18
.785
.000
9
.522
.150
ResearchGate has not been able to resolve any citations for this publication.
Article
Full-text available
Background Approximately 40% of women and 30% of men describe sexual dysfunction, although recognition in medical settings is suboptimal, due to problems in reporting and eliciting concerns relating to sexual function and satisfaction. Screening questionnaires may help to support this aspect of clinical practice. The Arizona sexual experiences scale (ASEX) includes items that quantify sex drive, arousal, vaginal lubrication or penile erection, ability to reach orgasm, and satisfaction from orgasm. Method We investigated the validity and other psychometric properties of the ASEX, and the findings from the populations in which it has been employed, by searching MEDLINE, EMBASE, and Google Scholar using the terms, Arizona sexual experiences scale, Arizona Sexual Experience Questionnaire, and ASEX. We eliminated duplications, letters, and papers not available in English, and grouped the remaining papers into the categories of psychometric, epidemiological, and outcome‐based studies. Results After elimination of letters and duplicates, papers not in English, and preclinical and irrelevant studies, 104 papers were analyzed. The ASEX has excellent internal consistency, scale reliability and strong test–retest reliability. Analyses of variance reveal significant differences in total ASEX scores between patients and controls and between females and males. ASEX appears to be useful in a range of clinical situations including patients with primary sexual dysfunction, specific psychiatric disorders, specific physical illnesses, and treatment emergent sexual dysfunction. Discussion The ASEX appears to be a reliable instrument for identifying and quantifying sexual dysfunction across a range of populations in various clinical settings. Little is known about its utility in patients with anxiety disorders or relationships between ASEX scores and biological parameters.
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Sexual dysfunction often accompanies severe psychiatric illness and can be due to both the mental disorder itself and the use of psychotropic treatments. Many sexual symptoms resolve as the mental state improves, but treatment-related sexual adverse events tend to persist over time, and are unfortunately under-recognized by clinicians and scarcely investigated in clinical trials. Treatment-emergent sexual dysfunction adversely affects quality of life and may contribute to reduce treatment adherence. There are important differences between the various compounds in the incidence of adverse sexual effects, associated with differences in mechanisms of action. Antidepressants with a predominantly serotonergic activity, antipsychotics likely to induce hyperprolactinaemia, and mood stabilizers with hormonal effects are often linked to moderate or severe sexual dysfunction, including decreased libido, delayed orgasm, anorgasmia, and sexual arousal difficulties. Severe mental disorders can interfere with sexual function and satisfaction, while patients wish to preserve a previously satisfactory sexual activity. In many patients, a lack of intimate relationships and chronic deterioration in mental and physical health can be accompanied by either a poor sexual life or a more frequent risky sexual behaviour than in the general population. Here we describe the influence of psychosis and antipsychotic medications, of depression and antidepressant drugs, and of bipolar disorder and mood stabilizers on sexual health, and the optimal management of patients with severe psychiatric illness and sexual dysfunction.
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Objective It is unclear whether selective serotonin-reuptake inhibitors (SSRIs) can significantly increase the prolactin level. The purpose of this study was to identify the relationship between the prolactin level and the administration of SSRIs such as escitalopram and sertraline. An additional purpose was to determine whether the elevation of prolactin differs between escitalopram and sertraline treatment. Methods Serum prolactin levels were measured at baseline and after 3 months in 23 patients who received SSRI monotherapy with escitalopram (n=18) (ESC group) or sertraline (n=5) (SERT group) for 3 months. Results The prevalence of hyperprolactinemia at posttreatment was 34.8% (8/23). The overall pretreatment and posttreatment prolactin levels were 21.86±20.21 and 19.89±12.03 ng/mL (mean±SD), respectively, with ranges of 6.85–86.20 and 5.19–47.61 ng/mL. The pretreatment and posttreatment prolactin levels were 20.66±15.92 and 21.97±12.33 ng/mL, respectively, in the ESC group, and 26.18±33.75 and 12.43±7.76 ng/mL in the SERT group. Conclusion Clinicians should be aware that hyperprolactinemia can appear in patients receiving escitalopram or sertraline, even though they do not need routine monitoring for prolactin levels.
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Background Hair cortisol concentration (HCC) can be used to periodically assess hypothalamic–pituitary–adrenal (HPA) axis function, and appears correlated with prolonged exposure to stress. Methods Serial assessment (at Baseline, Week 6 and Week 12) of participants ( n = 35) with anxiety disorders by psychopathological rating scales, with assays of HCC and levels of peripheral anti- and pro-inflammatory cytokines. Patients underwent antidepressant treatment for an initial 6 weeks, followed by cyclo-oxygenase inhibitor-2 (COX-2) inhibitor (celecoxib) augmentation or ‘treatment as usual’ for a further 6 weeks. Results At Baseline ( n = 35), HCC was elevated in patients with single-episode but not recurrent-episode anxiety disorders, mean IL-12p70 levels were low, and mean TNF-α levels were elevated. Following 6 weeks of antidepressant treatment ( n = 33), mean HCC was within the normal range but mean IL-2 level was low. Celecoxib augmentation ( n = 18) was associated with a reduction in anxiety symptoms and normalisation of mean IL-2 levels. Limitations Small sample size. Not all participants were assessed at all time points. Conclusion Serial assessment of HCC is practicable in patients with anxiety disorders. These preliminary findings warrant further investigation in larger samples.
Article
Objectives: To assess sexual behaviour, prevalence of ICD-10 diagnosed sexual dysfunction, associations between sexual and psychological problems, and help seeking for sexual problems in people attending general practice; to assess predictors of ICD-10 diagnosis of sexual dysfunction. Design: Cross sectional study. Setting: 13 general practices in London. Participants: 1065 women and 447 men attending general practices. Main outcome measure: Prevalence and predictors of ICD-10 diagnoses of sexual dysfunction. Results: 97 (22%, 95% confidence interval 18% to 25%) men and 422 (40%, 37% to 43%) women received at least one ICD-10 diagnosis, but only 3-4% had an entry relating to sexual problems in their general practice notes. The most common problems were erectile failure and lack or loss of sexual desire in men and lack or loss of sexual desire and failure of orgasmic response in women. Increasing age and being unemployed predicted sexual problems in women, and bisexual orientation, being non-white, and being unemployed were demographic predictors in men. No practice note factors predicted sexual problems in women, but high consulting rate predicted problems in men. The main clinical predictors were poor physical function and dissatisfaction with current sex life in both sexes and higher psychological morbidity in women. When all factors were considered, increasing age (odds ratio 1.01, 1.00 to 1.02), physical subscale score on the SF-12 (0.98, 0.97 to 0.99), sexual dissatisfaction (1.9, 1.5 to 2.4), and scoring over a 3/ 4 threshold score on the general health questionnaire (1.5, 1.1 to 1.9) independently predicted an ICD-10 sexual dysfunction diagnosis in women. Being bisexual (4.1, 1.3 to 12.8) was the only independent predictor of an ICD-10 diagnosis in men. Conclusions: Sexual difficulties are common in people attending general practitioners, and many people are prepared to talk about them with their doctors.
Article
Little is known about the associations between common mental disorders and sexual dissatisfaction in the general population. To assess the associations between the presence of 12-month and remitted (lifetime minus 12-month) mood, anxiety and substance use disorders and sexual dissatisfaction in the general population of The Netherlands. A total of 6646 participants, aged 18-64, took part in a face-to-face survey using the Composite International Diagnostic Interview 3.0. Childhood trauma, somatic disorders and sexual dissatisfaction were also assessed in an additional questionnaire. Associations were assessed with multivariate regression analyses. In total, 29% reported some sexual dissatisfaction. Controlling for demography, somatic disorders and childhood trauma, significant associations with 12-month mood disorder (B = 0.31), substance use disorder (B = 0.23) and anxiety disorder (B = 0.16) were found. Specifically, relatively strong associations were found for alcohol dependence (B = 0.54), bipolar disorder (B = 0.45) and drug dependence (B = 0.44). The association between remitted disorders and sexual dissatisfaction showed significance for the category substance use disorder. People with mood, anxiety and substance use disorders show elevated scores on sexual dissatisfaction, even when relevant confounders are controlled for. Sexual satisfaction appears to be reduced most by alcohol and drug dependence and bipolar disorder. Once remitted, substance use disorder shows a persisting association with present sexual dissatisfaction.