An Open-Label Evaluation of the Long-Term Safety of Oral Venlafaxine in Depressed Elderly Patients

Department of Psychiatry, University of Gent, Afsnee, Belgium.
Annals of Clinical Psychiatry (Impact Factor: 2.36). 09/1996; 8(3):169-78. DOI: 10.3109/10401239609147754
Source: PubMed


This open-label, multicenter study of depressed men and women > or = 65 years old was conducted at 18 European hospitals to evaluate the safety, efficacy, and clinical acceptability of venlafaxine in elderly depressed patients during 1 year. Patients received venlafaxine orally as 25-mg tablets two or three times daily for up to 12 months, Dosages were titrated upward during the first 15 days and then maintained between 50 and 150 mg/day. Safety was assessed on the basis of study events, vital signs, electrocardiograms tracings, and laboratory determinations. Efficacy was assessed using the Montgomery-Asberg Depression Rating Scale (MADRS), the Clinical Global Impressions (CGI) scale, and the Hospital Anxiety and Depression scale. Patients' subjective ratings of the drug's tolerability and efficacy were collected. Study events were reported by 62% of patients. Few clinically or statistically significant changes occurred in vital signs or electrocardiogram or laboratory findings. No serious study events, including three deaths, were considered unexpected given the nature of the population and the length of treatment. Most patients (81%) believed they had no side effects. Clinical response was achieved in 67% of patients by month 2 (as measured by improvement on the CGI) and by 64% of patients by month 3 (as measured by improvement on the MADRS), suggesting that venlafaxine demonstrates antidepressant efficacy. Eighty-five (73%) patients were still in the study after 6 months and 77 (66%) were still participating at 12 months. Overall, most patients (80%) felt much or very much improved at the end of the study. Venlafaxine was safe, effective, and clinically acceptable treatment for depression in elderly patients.

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    • "Patients with major depression have on average a higher body mass index (BMI) and tend to demonstrate a decreased improvement with antidepressant treatment, compared to patients with lower BMI (Kloiber et al. 2007). For treatment of elderly patients diagnosed with depression, venlafaxine has been shown to be effective (Allard et al. 2004; Amore et al. 1997; Dierick 1996; Gastó et al. 2003; Thase et al. 2001). This effectiveness might be attributed to the characteristic of venlafaxine, a dual action drug inhibiting the reuptake of both, serotonin and norepinephrine (Harvey et al. 2000; Holliday and Benfield 1995). "
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    ABSTRACT: Venlafaxine (VEN) is a modern antidepressant which exerts both serotonin and norepinephrine reuptake inhibition. In this study we examined the influence of age, sex, smoking, and co-medication on serum levels of VEN and its metabolite O-desmethylvenlafaxine (ODVEN) in patients treated with VEN under naturalistic conditions.We retrospectively evaluated 478 TDM analyses of VEN requested in the Pychiatric University Hospitals of Mainz, Regensburg, and Würzburg. The determination of serum levels was performed by virtually identical chromatographic methods in the TDM laboratories of the participating hospitals.Serum levels varied widely on each dose level. Women had about 30% higher dose-corrected serum levels of VEN and ODVEN than men (p<0.01), and patients older than 60 years showed about 46% higher levels of both compounds than younger ones (p<0.01). In smokers, mean serum levels of ODVEN were 21% lower than in non-smokers. Combining these variables a considerable increase of the differences between the subgroups was found indicating an additive effect. ANOVA over the 8 different groups was significant for ODVEN (p<0.01) and sum (p<0.01), but not for VEN (n.s.). Co-medication with other psychotropic drugs was associated with a decreasing ODVEN/VEN ratio indicating a reduced metabolism in patients receiving polypharmacy.These findings show that TDM is useful to identify factors affecting the pharmacokinetic properties of VEN. It is concluded that sex, age and smoking should be considered for optimal dosing of patients with VEN.
    Pharmacopsychiatry 03/2012; 45(6):229-35. DOI:10.1055/s-0031-1301366 · 1.85 Impact Factor
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    • "90 R55 60 RCT HAM-D 9 30% remission for duloxetine vs 13% for placebo; significant reduction in pain compared with placebo Venlafaxine Dierick 1996 [56] 116 R65 25–150 Open label CGI, MADRS 52 67% of patients achieved clinical response by 2 mo Abbreviations: CGI, Clinical Global Impression; HAM-D, Hamilton Rating Scale for Depression; "
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    ABSTRACT: Late-life depression is under-recognized and undertreated in older adults. Depressed older adults who are at an increased risk or undertreatment include patients older than 85 years, those with comorbid medical conditions, and older adults with cognitive impairment receiving home health care or living in nursing homes. Although the existing empirical treatment literature is limited, the available published treatment studies and expert consensus recommendations find that antidepressants are effective. In general the SSRIs and SNRIs pose a low risk for the most serious side effects. Treatment of psychotic depression has not been adequately investigated in older adults, although common practice includes treatment with an SSRI or SNRI in conjunction with an atypical antipsychotic. Treating with antidepressants augmented by psychotherapy can minimize relapse and disability in depressed patients. Continuation and maintenance treatment at an adequate dose and for an adequate length of time is critical in minimizing relapse. Empirical trials are needed that evaluate the selection and effectiveness of pharmacologic combination therapy and other treatment strategies for treatment resistant and partially responsive major depressive disorder in older adults.
    Psychiatric Clinics of North America 01/2006; 28(4):821-35, viii. DOI:10.1016/j.psc.2005.09.012 · 2.13 Impact Factor
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    ABSTRACT: One of the common mental disorders seen in elderly population is depression.Though the incidence of depression is similar to that seen in younger adults; when it occurs it is more likely to be severe with higher risk of suicide and frequently requires hospital admission. It leads to more number of consultations with the treating agencies. It also leads to significant burden on families. Early recognition, diagnosis, and initiation of treatment for depression in older people present opportunities for improving their quality of life, preventing suffering or premature death, and maintaining optimal levels of function and independence. Earlier diagnosis and effective treatment of depression in old age can lead to significant reduction in morbidity, mortality due to suicide and medical illnesses and health care costs. The purpose of these guidelines is to present a framework for the evaluation, treatment, and follow- up of geriatric patient, who present with depression. To a large extent these guidelines are evidence based. Most of the data presented in these guidelines is from the western countries, as there is only meager research from India and other developing countries. For the purpose of review of literature, the studies which have been reviewed have been limited to the population aged 60 or more. We hope that these guidelines would help in facilitating proper management and avoiding unnecessary expense and inconvenience. However it is to be remembered that these guidelines are not a substitute for professional knowledge and clinical judgement.
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