BEAM-BD
Trial question
What is the role of 52 weeks of adjunctive antidepressant therapy in patients with bipolar I disorder who recently had remission of a depressive episode?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
52.0% female
48.0% male
N = 177
177 patients (92 female, 85 male).
Inclusion criteria: patients with bipolar I disorder who recently had remission of a depressive episode.
Key exclusion criteria: receipt of other psychotropic medications; except benzodiazepines; current substance use disorder.
Interventions
N=90 adjunctive therapy for 52 weeks (adjunctive escitalopram or bupropion XL therapy for 52 weeks).
N=87 adjunctive therapy for 8 weeks (adjunctive escitalopram or bupropion XL therapy for 8 weeks, switch to placebo for remaining 44 weeks).
Primary outcome
Occurrence of any mood episode at week 52
31%
46%
46.0 %
34.5 %
23.0 %
11.5 %
0.0 %
Adjunctive therapy for 52
weeks
Adjunctive therapy for 8
weeks
No significant
difference ↔
No significant difference in the occurrence of any mood episode at week 52 (31% vs. 46%; HR 0.68, 95% CI 0.43 to 1.1).
Secondary outcomes
No significant difference in episode of mania or hypomania at week 52 (12% vs. 6%; HR 2.28, 95% CI 0.86 to 6.08).
Significant decrease in recurrence of depression at week 52 (17% vs. 40%; HR 0.43, 95% CI 0.25 to 0.75).
Borderline significant increase in Montgomery-Asberg Depression Rating Scale or Young Mania Rating Scale score of ≤ 8 (60% vs. 45%; AD 15%, 95% CI 0 to 30.9).
Safety outcomes
No significant difference in adverse events.
Significant difference in weight gain ≥ 7% of body weight (14% vs. 7%).
Conclusion
In patients with bipolar I disorder who recently had remission of a depressive episode, adjunctive therapy for 52 weeks were not superior to adjunctive therapy for 8 weeks with respect to the occurrence of any mood episode at week 52.
Reference
Lakshmi N Yatham, Shyam Sundar Arumugham, Muralidharan Kesavan et al. Duration of Adjunctive Antidepressant Maintenance in Bipolar I Depression. N Engl J Med. 2023 Aug 3;389(5):430-440.
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