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MEDTECH How effective is prolonged antidepressant maintenance in preventing mood episode relapses in bipolar I depression?
Antidepressants have been a cornerstone in treating acute depression in bipolar I disorder patients. However, the long-term efficacy of these drugs as a maintenance treatment post-remission remains a subject of debate. This study delves into the effects of prolonged antidepressant therapy versus a shorter duration in preventing mood episode relapses.
Study Design:
- Multisite, double-blind, randomized, placebo-controlled trial.
- Ninety (90) patients were assigned to the 52-week antidepressant group and 87 to the 8-week placebo group.
- Participants: 209 patients with bipolar I disorder participated in an open-label treatment phase. Out of these, 150 who had remission of depression were enrolled in the double-blind phase, along with 27 patients enrolled directly.
- Intervention: Patients were randomized 1:1 to either continue with antidepressants (escitalopram or bupropion XL) for 52 weeks post-remission or switch to placebo at 8 weeks.
- Primary Outcome: Any mood episode, determined by scores on scales measuring symptoms of hypomania, mania, depression, suicidality, mood-episode severity, additional treatment/hospitalization for mood symptoms, or attempted/completed suicide.
- Secondary Outcomes: Time to an episode of mania, hypomania, or depression.
Key Findings:
- By 52 weeks, 31% (28 patients) in the 52-week group and 46% (40 patients) in the 8-week group had a primary-outcome event.
- Hazard ratio for time to any mood episode in the 52-week group vs. the 8-week group was 0.68 (95% CI, 0.43 to 1.10; P=0.12).
- 12% (11 patients) in the 52-week group vs. 6% (5 patients) in the 8-week group experienced mania or hypomania.
- 17% (15 patients) in the 52-week group vs. 40% (35 patients) in the 8-week group had a recurrence of depression.
- Adverse event incidence was comparable between the two groups.
Conclusion:
- For bipolar I disorder patients with a recently remitted depressive episode, extending adjunctive treatment with escitalopram or bupropion XL to 52 weeks did not significantly outperform an 8-week treatment in preventing mood episode relapses. The trial’s premature termination was due to slow recruitment and funding constraints.
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Did You Know?
According to the World Health Organization, bipolar disorder affects approximately 60 million people worldwide, with depressive episodes often being more frequent and longer-lasting than manic episodes.
