CNS drugs··
Desvenlafaxine treatment in postmenopausal women with depression who did not improve after initial desvenlafaxine or escitalopram
Updated
Abstract
At final evaluation, mean reductions in depression scores were -11.33 and -11.41 for two groups receiving desvenlafaxine treatment.
- 56-58% of postmenopausal women achieved a significant response to treatment after 6 months of open-label desvenlafaxine.
- 41-48% of patients reached remission based on the Hamilton Rating Scale for Depression after the same period.
- The results for secondary outcome measures aligned with the primary efficacy findings.
- Adverse events reported were consistent with those from prior desvenlafaxine studies.
Simplified
BACKGROUND: Preliminary clinical evidence indicates that menopausal status might impact on the efficacy of certain classes of antidepressants.
OBJECTIVE: The aim of this study was to evaluate open-label desvenlafaxine treatment (administered as desvenlafaxine succinate) in postmenopausal women who did not achieve clinical response to acute, double-blind treatment with desvenlafaxine or escitalopram.
STUDY DESIGN: This phase IIIb, multicentre study included a 6-month open-label extension phase of patients who did not respond in the initial 8-week, randomized, double-blind acute phase.
PATIENTS: Postmenopausal women aged 40-70 years with a primary diagnosis of major depressive disorder were recruited. PRIMARY INTERVENTION: Non-responders to acute treatment with double-blind desvenlafaxine or escitalopram received flexible-dose, open-label desvenlafaxine 100-200 mg/day for the 6-month extension phase.
MAIN OUTCOME MEASURE: The primary efficacy assessment was the 17-item Hamilton Rating Scale for Depression (HAM-D(17)) total score. Secondary efficacy outcome measures were the Clinical Global Impressions-Improvement (CGI-I) and -Severity scales, Hamilton Rating Scale for Anxiety, Quick Inventory of Depressive Symptomatology-Self-Report, Visual Analogue Scale-Pain Intensity and the Montgomery-Åsberg Depression Rating Scale (MADRS). Secondary health assessments were the Changes in Sexual Functioning Questionnaire, 5-Dimension EuroQoL Index, Health State Today, Menopause Rating Scale, Sheehan Disability Scale, treatment response (≥ 50% decrease in total HAM-D(17) and MADRS score from acute-phase baseline and CGI-I total score ≤ 2), HAM-D(17) remission (total score ≤ 7) and safety. Descriptive statistics were used to summarize outcomes.
RESULTS: The efficacy analysis included 123 patients (desvenlafaxine/desvenlafaxine = 64; escitalopram/desvenlafaxine = 59). At final evaluation of the open-label extension phase, mean reductions from acute-phase baseline in HAM-D(17) total scores were -11.33 for the desvenlafaxine/desvenlafaxine group and -11.41 for the escitalopram/desvenlafaxine group. HAM-D(17) response or remission after 6 months of open-label extension phase desvenlafaxine treatment were achieved in 56-58% and 41-48% of patients, respectively. The results of the other secondary efficacy outcome measures and other definitions of treatment response were generally consistent with the primary analyses. The observed adverse events were similar to those reported during previous desvenlafaxine clinical trials.
CONCLUSIONS: Postmenopausal women with major depressive disorder who did not respond to acute, double-blind treatment with escitalopram or desvenlafaxine achieved modest, continued improvement with long-term, open-label desvenlafaxine therapy. Further interpretation of these findings is limited by aspects of the study design (i.e. open-label, non-placebo-controlled) and the lack of randomized comparison groups in the extension phase, which prevents statistical assessment of the efficacy of longer term treatment with desvenlafaxine. Clinicaltrials.gov identifier: NCT00406640.
Related papers
Aug '09
Desvenlafaxine 50 and 100 mg/day for treating major depression: an 8-week controlled trial and combined analysis of three studies
cited by 51 papers
randomized controlled trial
Apr '15
Desvenlafaxine’s effectiveness for treating major depression in women during and after menopause
top 10% journal
cited by 26 papers
research support, non-u.s. gov't
Aug '10
Short-term benefits and safety of desvenlafaxine for depression in women during and after menopause in a controlled trial
top 10% journal
cited by 51 papers
randomized controlled trial
May '07
Desvenlafaxine’s safety and effectiveness for treating major depression in a controlled study
top 10% journal
cited by 79 papers
randomized controlled trial
Dec '07
Desvenlafaxine treatment compared to placebo in adults with major depression
top 10% journal
cited by 48 papers
randomized controlled trial
Jan '14
Effectiveness and safety of desvenlafaxine 50 mg/day in treating major depression in women around and after menopause
top 20% journal
cited by 20 papers
randomized controlled trial
Nov '13
Effectiveness and safety of 50 mg desvenlafaxine in treating major depression in women around and after menopause
top 10% journal
cited by 55 papers
randomized controlled trial
Nov '09
Desvenlafaxine 50 mg daily for treating major depression: results from two placebo-controlled trials for doctors
cited by 8 papers
systematic review
Oct '07
Desvenlafaxine's effects compared to placebo in treating major depression in a controlled clinical trial
cited by 68 papers
randomized controlled trial