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.
- 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.
- 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.
- 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.
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.