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The New England Journal of MedicineDuration of Adjunctive Antidepressant Maintenance in Bipolar I Depression

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.


  • 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.

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