Continuation of escitalopram or bupropion XL in patients with bipolar I disorder and a recently remitted depressive episode did not show a significant benefit when used for 52 weeks as compared with treatment for 8 weeks in preventing relapse of any mood episode, researchers report. Conducted at sites in Canada, Korea, and India, the adjunctive antidepressant trial was stopped early because of slow recruitment and funding limitations.
The double-blind, randomized, placebo-controlled trial compared the maintenance of treatment with adjunctive escitalopram or bupropion XL as compared with discontinuation of antidepressant therapy in patients with bipolar I disorder who had recently had remission of a depressive episode. Participants were assigned to continue treatment with antidepressants for 52 weeks after remission or to switch to placebo at 8 weeks. Assessed in a time-to-event analysis, the primary outcome was any mood episode, depression, suicidality, and mood-episode severity; additional treatment or hospitalization for mood symptoms; or attempted or completed suicide.
“Of 209 patients with bipolar I disorder who participated in an open-label treatment phase, 150 who had remission of depression were enrolled in the double-blind phase in addition to 27 patients who were enrolled directly,” the authors report. “A total of 90 patients were assigned to continue treatment with the prescribed antidepressant for 52 weeks (52-week group) and 87 were assigned to switch to placebo at 8 weeks (8-week group). The trial was stopped before full recruitment was reached owing to slow recruitment and funding limitations. At 52 weeks, 28 of the patients in the 52-week group (31%) and 40 in the 8-week group (46%) had a primary-outcome event. The hazard ratio for time to any mood episode in the 52-week group relative to the 8-week group was 0.68 (95% confidence interval [CI], 0.43 to 1.10; P=0.12 by log-rank test). A total of 11 patients in the 52-week group (12%) as compared with 5 patients in the 8-week group (6%) had mania or hypomania (hazard ratio, 2.28; 95% CI, 0.86 to 6.08), and 15 patients (17%) as compared with 35 patients (40%) had recurrence of depression (hazard ratio, 0.43; 95% CI, 0.25 to 0.75). The incidence of adverse events was similar in the two groups.”