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Abstract

Background: Aripiprazole is a novel antipsychotic medication that has been tried in the treatment of several psychiatric disorders. In an open clinical study, we evaluated the safety and efficacy of aripiprazole in patients with obsessive compulsive disorder resistant to normal regimen of treatment. Method: A total of nine hundred and sixty one patients were admitted over three year period of time (January 2012- December 2014) to the psychiatric department of Al Ain hospital, United Arab Emirates. All patients whose been fulfilled DSM-IV diagnosis of obsessive compulsive disorder (OCD) (36 patients) screened for further assessment. Patients with a diagnosis of schizophrenia (22 patients) and one patient with eating disorder were excluded. Thirteen patients were contacted to be involved in the study. Participants were unstable although they were adherent to their medications (SSRIs) when seen in the outpatient clinic two weeks after their discharge. One patient refused to participate in the study. A final number of 12 agreed to participate in the study. twelve patients aged 22 to 65 years who had DSM-IV diagnosis of OCD were treated with aripiprazole besides their normal treatment for a period of three months with daily doses ranging from ten to 20 mg daily. Results: a positive clinical response was noted in eight of the 12 patients within three months of study recruitment according to the Clinical Global Impression-Improvement scale. Aripiprazole was well tolerated by most of the patients. The most commonly reported side effect was headache. Conclusion: our findings suggest that aripiprazole may be an effective adjuvant and safe treatment for resistant OCD.
Aripiprazole Augmentation in Treatment of
Resistant Obsessive Compulsive Disorder
Karim Abdel Aziz1, Nisrin M El-Saadouni2, Mohammed Hashim E. Elamin3, Dina Aly El-Gabry4,
and Hamdy F Moselhy1
1. College of Medicine, UAE University, UAE, AL Ain P O Box 17 666
2. Faculty of Medicine, Mansoura University, Egypt
3. Behavior Sciences Institute, Al Ain Hospital, UAE, AL Ain P O Box 17 666
4. Institute of Psychiatry, Ain Shams University, Egypt
* Email: hamdy.fouad@uaeu.ac.ae
Abstract
Background: Aripiprazole is a novel antipsychotic medication that has been tried in the treatment of several
psychiatric disorders. In an open clinical study, we evaluated the safety and efficacy of aripiprazole in patients
with obsessive compulsive disorder resistant to normal regimen of treatment.
Method: A total of nine hundred and sixty one patients were admitted over three year period of time (January
2012- December 2014) to the psychiatric department of Al Ain hospital, United Arab Emirates. All patients
whose been fulfilled DSM-IV diagnosis of obsessive compulsive disorder (OCD) (36 patients) screened for
further assessment. Patients with a diagnosis of schizophrenia (22 patients) and one patient with eating disorder
were excluded. Thirteen patients were contacted to be involved in the study. Participants were unstable although
they were adherent to their medications (SSRIs) when seen in the outpatient clinic two weeks after their
discharge. One patient refused to participate in the study. A final number of 12 agreed to participate in the study.
twelve patients aged 22 to 65 years who had DSM-IV diagnosis of OCD were treated with aripiprazole besides
their normal treatment for a period of three months with daily doses ranging from ten to 20 mg daily.
Results: a positive clinical response was noted in eight of the 12 patients within three months of study
recruitment according to the Clinical Global Impression-Improvement scale. Aripiprazole was well tolerated by
most of the patients. The most commonly reported side effect was headache.
Conclusion: our findings suggest that aripiprazole may be an effective adjuvant and safe treatment for resistant
OCD.
Key words: OCD, aripiprazole, augmentation therapy
Introduction
Obsessive compulsive disorder (OCD) is an illness that considerably influences social, occupational, and
families of patients. Current treatments for OCD rely on serotonergic mechanisms. Many authors have
recommended serotonergic antidepressants (SSRIs) for obsessive compulsive disorder [1]. However, their use
raises some problems. Drug effects do not last beyond a few months, relapses are common after drug
withdrawal [2] and side effects can be a problem [3]. In addition, 30% of patients do not respond to serotonin
reuptake inhibitors and remain chronically ill [4]. In a recently published study [4], 8-week, single-blind,
randomized trial comparing risperidone versus olanzapine augmentation of serotonin reuptake inhibitors in
treatment-resistant OCD, found that patient in both groups responded significantly, without differences between
the two treatment groups. Fineberg et al [5] reviewed the evidence for co-administration of antipsychotics in
SRI-resistant cases of OCD, based upon, whenever possible, randomized controlled trials. They concluded that
the results favour the use of second generation antipsychotics such as risperidone and quetiapine as a first-line
strategy for augmentation in resistant OCD. Several reports have suggested successful augmentation with
aripiprazole in SRI refractory patients with OCD [6, 7, 8, 9, 10]. This article reports on the open clinical
experience of treating 12 patients who had an obsessive compulsive disorder with aripiprazole, as adjuvant
medication. Participants and Procedure:
A total of nine hundred and sixty one patients were admitted over three year period of time (January
2012- December 2014) to the psychiatric department of Al Ain hospital, United Arab Emirates. All
patients whose been fulfilled DSM-IV diagnosis of obsessive compulsive disorder (OCD) (36
patients) screened for further assessment. Patients with a diagnosis of schizophrenia (22 patients) and
one patient with eating disorder were excluded. Thirteen patients were contacted to be involved in
the study. Participants were unstable although they were adherent to their medications (SSRIs) when
seen in the outpatient clinic two weeks after their discharge. One patient refused to participate in the
study. A final number of 12 agreed to participate in the study. The nature and scope of the study were
Karim Abdel Aziz et al./ International Journal of Pharma Sciences and Research (IJPSR)
ISSN : 0975-9492
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77
discussed with each subject and written informed consent was obtained from all subjects prior to
distribution of the questionnaire.
Participants were interviewed in the outpatient at Al Ain teaching Hospital, in Al Ain city, United
Arab Emirates in accordance with the Al Ain Medical District Human Research Ethics Committee.
Diagnosis was based on the Diagnostic and Statistical Manual of Mental disorders 4th Edition Text
Revision (DSM-IV-TR) clinical criteria (APA 2000) by way of a semi-structured interview,
comprehensive medical and psychiatric history taking, mental state examination and collateral
information from family members.
The subjects' age ranged from 22years to 65years (mean=37.7 years), eight males and four females. There was a
wide variation in ethnicity: two patients were Syrian, two were Pakistani, and two were German, one Jordanian,
two Indonesian and three Egyptians. Mean duration of obsessive compulsive disorder was 12.7 years. The
duration of any SRI medication prior to add aripiprazole was at least 3 months without response. All the patients
were in contact with service for an average of two years. Informed consent was constantly obtained from the
patients, and Declaration of Helsinki guidelines were followed.
Diagnosis was made according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition
(DSM IV) [11]. Comorbid diagnoses were ruled out during the interview for common psychiatric diagnoses.
Principal measure for OCD severity of symptoms was Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
[12]. During the initial evaluation, the mean Y-BOCS scores for the responder group were 25.5; this
corresponds to a global severity in the severe range. OCD was present in all the patients (4 had the 'obsessions'
subtype and eight had the combination of obsession and compulsions subtype of OCD) (Table 1).
Aripiprazole treatment was started in doses of ten mg once daily and increased gradually (in increments of five
per two weeks) to a maximum of 20 mg per day. Clinical efficacy was assessed on a fortnightly basis using
Clinical Global Impression-Improvement scale (CGI-I) (13), and patients were prompted to report commonly
observed side effects such as insomnia, headaches, fatigue, dizziness, nausea, vomiting, sedation, and dyspepsia
and extrapyramidal side effects. Results
Clinical improvement was noted in eight patients within six weeks of recruitment into the study (table 1): scores
on CGI-I showed mild improvement (score of +1) in three patients (cases 5, 7, 10), moderate improvement
(score of +2) in five (cases 2, 8, 9, 11, 12), significant improvement (score of +3) in one (case 6) and no change
(score 0) in two (cases 3, 4). Symptoms were reported to be worse (score of -1) in one patient (case 1). The
mean Y- BOCS score of the responder group at the end of the three months was 9; this corresponds to a global
severity in the mild range.
Aripiprazole was effective in improving OCD, either obsessions or the combined form of obsessions and
compulsions. A headache was reported in three patients, requiring reduction in dosage but not discontinuation.
The other side effects reported included tiredness and insomnia. No patients experienced extrapyramidal
symptoms. However, one patient developed tremors, but she was on clomipramine as well. Those who showed a
positive clinical response were followed up for periods ranging from 4-12 months.
Discussion
Although SSRI remain the mainstay of pharmacologic treatment for OCD, they may not be tolerated by some
patients, may be ineffective in some, and in yet others may exacerbate a comorbid medical condition such as
nausea and delayed orgasm [3]. Furthermore, side effect profile of the conventional antidepressant
(clomipramine) used in this situation includes symptoms typical of both potent 5-HT reuptake inhibitors and
tricyclics. In our cohort, aripiprazole was used for periods of up to 12 months with no undesirable effects.
However, it is important to evaluate the longer-term effectiveness and safety of aripiprazole in this population.
Aripiprazole has been noted to be useful for controlling acute agitation in patients with schizophrenia or
schizoaffective disorder [14, 15] and bipolar disorder [16] and in primary and comorbid anxiety symptoms [17].
Our findings showed that aripiprazole was effective in improving both obsessions and compulsions in OCD.
These suggest that aripiprazole has promise for treatment of patients with OCD disorder. Furthermore, there was
improvement in coexisting anxiety and agitation problems. The drug was well tolerated by the patients in dosage
used (10-20 mg). The most common side effect reported by patients was headaches in three patients, followed
by tiredness and insomnia in one patient each.
There have been few controlled evaluations of pharmacological approaches to OCD patients who have not
responded to an adequate trial of a 5-HT reuptake inhibitor alone. In an open case series, some OCD patients
seemed to benefit from the addition of low doses of antipsychotic medication to SSRI treatment [18].
Meanwhile, other reports suggest that some atypical antipsychotics may have obsessogenic as well as
antiobsessional effects. Given their higher affinity for serotonin 5HT2 receptors than dopamine D2 receptors, it
has been speculated that atypical antipsychotics may induce obsessive-compulsive symptoms, even at low
Karim Abdel Aziz et al./ International Journal of Pharma Sciences and Research (IJPSR)
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doses, on account of high 5HT2 antagonism, whereas improvement in obsessive-compulsive symptoms is
assumed to occur only at high doses in consequence of high D2 antagonism [19]. However, aripiprazole is a
novel antipsychotic agent, is assumed to be a “dopamine-serotonin system stabilizer”. According to preclinical
studies, aripiprazole exerts partial agonist on D2 and 5-HT1A receptors. Thus, it may block a receptor if it is
over stimulated and stimulate a receptor when activity is needed. It also has the antagonist properties at 5-HT2A
receptors [20]. In our cohort there was no effect on 2 cases but symptoms were slightly exacerbated in one case
which supports the uniqueness of action of aripiprazole compared with other antipsychotic medications.
Substantial methodological limitations, particularly the lack of double-blind placebo for a randomly assigned
control, preclude any current generalizations from these findings. Further double blind placebo controlled
studies will be needed to support this work. References
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obsessive compulsive disorder. Turk Psikiyatri Drg 2008; 19 (1): 38-45
[2] Thoren R, Asberg M, Cronholm B, Jonertedt L, and Traskman L. clomipramine treatment of obsessive compulsive disorder: a
controlled study. Arch Gen Psychiatry 1980; 37: 1281-1285
[3] Monteiro W, Lelliott P, Marks I and Noshirvani H. anorgasmia from clomipramine in obsessive compulsive disorder. Br J Psychiatry
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[4] Maina G, Pessina E, Albert U, Bogetto F. 8-week, single-blind, randomized trial comparing risperidone versus olanzapine
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[5] Fineberg NA, Gale TM, Sivakumaran T. a review of antipsychotics in the treatment of OCD. J Psychopharmacology 2006; 20 (1): 97-
103
[6] Storch EA, Lehmkuhl H, Geffken GR, Touchton A, Muephy TK. Aripiprazol augmentation of incomplete treatment response in an
adolescent male with obsessive-compulsive disorder. Depress Anxiety 2008; 25 (2): 172-174
[7] Conor KM, Payne VM, Gadde KM, Zhang W, Davidson JR. the use of aripiprazol in obsessive-compulsive disorder: preliminary
observations in eight patients. J Clin Psychiatry 2005, 66(1): 49-51
[8] Filardi da Roch F, Correa H. successful augmentation with aripiprazole in clomipramine-refractory OCD. Progress in Neuro-
Psychopharmacology and Biological Psychiatry 2007; 7: 1550-1551
[9] Marino J, Mascarenas CA, Saklad SR, Simpson JA. Case report: aripiprazole for treatment of resistant OCD. JCNP 2007: 1-5
[10] Sarkar R, Klein J, Kruger S. Aripiprazole augmentation in treatment refractory OCD. Psychopharmacology 2008; 197 (4): 687-688
[11] American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. Fourth Edition, Washington, DC: American
Psychiatric Association; 1994
[12] Guy W. ECDEU Assessment Manual for Psychopharmacology. US Dept Health, Education, and Welfare publication (ADM) 76-338.
Rockville, Md: National Institute of Mental Health; 1976: 218-222
[13] Goodman WK, Price LH, Rasmussen SA, Mazure C, Fleischmann R, Hill C, Heninger GR, Charney DS. The Yale-Brown Obsessive
Compulsive Scale (Y-BOCS): Part I. development, use and reliability. Arch Gen Psychiatry 1989; 46: 1006-1011
[14] Andrezina R, Josaiassen RC, Marcus RN, Oren DA, Manos G, Stock E, Carson WH, Iwamoto T. intramuscular aripiprazole for the
treatment of acute agitation in patients with schizophrenia or schizoaffective disorder: a double-blind, placebo-controlled comparison
with intramuscular haloperidol. Psychopharmacology 2006; 188(3): 281-292
[15] Tran-Johnson TK, Sack DA, Marcus RN, Auby P, Mcquade RD, Oren DA. Efficacy and safty of intramuscular aripiprazole in patients
with acute agitation: a randomized, double-blind, placebo-controlled trial. J Clin Psychiatry 2007; 68(1): 111-119
[16] Currier GW, Citrome LL, Zimbroff DL, Oren D, Manos G, McQuade R, Pikalov AA 3rd, Crandall DT. Intramuscular aripiprazole in
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[17] Gao K, Muzina D, Gajwani P, Calabrese JR. Efficy of typical and atypical antipsychotics for primary and comorbid anxiety symptoms
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[19] Ramasubbu R, Ravindran A, Lapierre Y. serotonin and dopamine antagonism in obsessive-compulsive disorder: effect of atypical
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6: 9-16
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Table 1: Characteristics of patients with OCD treated with aripiprazole
Patient Age
(years) Sex Initial complaints Pre-
YBOCS Post-
YBOCS Other
medications used
in combination
Aripiprazole Treatment Outcome (CSI-
score) Side effects
Dose Duration of
follow up in
months
1 36 F Checking gas, taps,
lights 19 21 Paroxetine
Duloxetine 10mg/d 4 Worsening of
rituals, drug
discontinued (-
1)
Worsening of
symptoms
(increased
checking
2 28 F excessive cleaning
for hands 18 7 Flouextine
Clomipramine 10mg/d 10 Improved (+2) Tremors
3 32 M Repetitive religious
thoughts 27 25 Escitalopram
Fluoxetine 10mg/d 12 No
improvement (0) Headaches
4 22 F Repeating prayers
a number of times 30 26 Paroxetine
Clomipramine 10mg/d 12 No
improvement (0)
drug
discontinued
None
5 54 M Counting rituals 31 15 Paroxetine
Sertraline 10-
15mg/d 12 Improved (+1) Headaches
6 32 M Checking doors
and windows 30 8 Fluoxetine
Clomipramine 10-
15mg/d 8 Improved (+3) Tiredness
7 65 F Repetitive
frightening
thoughts about
children
28 10 Paroxetine
clomipramine 10-
15mg/d 8 Improved (+1) None
8 41 M Repeating prayers
a number of times 20 6 Fluoxetine
Clomipramine 15-
20mg/d 9 Improved (+2)
None
9 27 M Repeating things a
number of times 30 8 Sertraline
Escitalopram 15-
20mg/d 12 Improved (+2) None
10 30 M Repeating thoughts
of harming others 23 22 Fluoxetine
Paroxetine 15/20m
g/d 9 Improved (+1) Insomnia
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11 38 M excessive cleaning
for hands 27 9 Clomipramine
Paroxetine 10-
15mg/d 7 Improved (+2) None
12 46 M Feeling of
incompleteness
related to religious
practice
20 10 Fluoxetine
Clomipramine 10mg/d 6 Improved (+2) Headaches
Abbreviation: OCD=obsessive compulsive disorder, CGI-I= Clinical Global Impression-Improvement scale, F=female, M=male
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