Omega-3 as an adjunctive therapy of sertraline and venlafaxine substantially improves symptoms of major depressive disorder: A double-blind, placebo-controlled study

Background: Due to the possible effect of omega-3 fatty acids on reducing depressive symptoms, in this study, we investigated these effects in combination with other antidepressants. Methods: The study was a double-blind clinical trial on 100 patients with major depressive disorder who were divided into four groups of 25 each and treated with 50 mg daily sertraline plus placebo, 50 mg daily sertraline plus two grams Omega 3 daily, 75 mg daily venlafaxine plus placebo, and 75 mg daily venlafaxine plus 2 g Omega 3 daily for 6 weeks. Results: The mean Hamilton depression rating score of sertraline and venlafaxine plus omega-3 after treatment were 4.42 and 4.23 respectively versus sertraline and venlafaxine plus placebo 14.4 and 14.2 respectively (P value=0.0001). Conclusion: Omega-3 enhanced the clinical function of sertraline and venlafaxine to reduce the severity of depression. Adding omega-3 to either sertraline or venlafaxine does not have a comparative advantage over each other in terms of the improvement of severity of depressive symptoms. Trial registration : number is IRCT20190302042885N1.

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Aripiprazole Augmentation in Major Depressive Disorder: A Double-Blind, Placebo-Controlled Study in Patients with Inadequate Response to Antidepressants

CNS Spectrums ◽

10.1017/s1092852900020216 ◽

2009 ◽

Vol 14 (4) ◽

pp. 197-206 ◽

Cited By ~ 157

Author(s):

Robert M. Berman ◽

Maurizio Fava ◽

Michael E. Thase ◽

Madhukar H. Trivedi ◽

René Swanink ◽

...

Keyword(s):

Major Depressive Disorder ◽

Depressive Symptoms ◽

Adverse Events ◽

Depressive Disorder ◽

Controlled Study ◽

Inadequate Response ◽

Completion Rates ◽

Madrs Total Score ◽

Major Depressive ◽

Double Blind

ABSTRACTIntroduction: Effective management of major depressive disorder (MDD) continues to be a challenging task for psychiatrists and primary care physicians. This trial evaluated the efficacy and safety of adjunctive aripiprazole versus antidepressant monotherapy in patients with MDD and independently replicated the positive findings of two similar trials.Methods: Patients (N=1, 147) with MDD experiencing a major depressive episode and a history of inadequate response to antidepressant monotherapy were enrolled (week 0); 827 received single-blind adjunctive placebo plus open-label antidepressant (escitalopram, fluoxetine, paroxetine controlled release, sertraline, or venlafaxine extended release) for 8 weeks to confirm inadequate response to antidepressants; 349 patients with inadequate response were randomized (1:1) to double-blind, adjunctive placebo (n=172) or adjunctive aripiprazole (n=177; 2–20 mg/day). Primary outcome was the mean change in Montgomery-Åsberg Depression Rating Scale (MADRS) Total score from baseline (week 8) to endpoint (week 14).Results: Clinically significant improvements in depressive symptoms as assessed by decreases in the MADRS Total score were greater with adjunctive aripiprazole (−10.1) than placebo (−6.4; P<.001). Remission rates were greater for adjunctive aripiprazole than for adjunctive placebo (week 14, 36.8% vs 18.9%; P<.001). Completion rates with adjunctive aripiprazole and placebo were high (83% vs. 87%) and discontinuations due to adverse events were low (6.2% vs 1.7%).Conclusion: For some patients with MDD who do not obtain adequate symptom relief with antidepressant monotherapy, adjunctive therapies can significantly improve depressive symptoms. As reported, adjunctive aripiprazole was associated with a two-fold higher remission rate than adjunctive placebo. This, and previous studies, have shown that discontinuations due to adverse events were low and completion rates were high, and has indicated that both antidepressant and aripiprazole in combination were relatively well-tolerated and safe. This is the third consecutive clinical trial, in the absence of a failed trial, to demonstrate that aripiprazole augmentation to antidepressants is an efficacious and well-tolerated treatment for patients with MDD who do not respond adequately to standard antidepressant monotherapy (ClinicalTrials.gov study NCT00105196).

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