Mood Stabilizer (MS)+ Antidepressant vs MS + Placebo in Maintenance of Bipolar Disorder.

Summary

Patients with bipolar I disorder (BD) experience depression 3 times more frequently than mania, and antidepressants are prescribed as adjuncts to mood stabilizers in up to 70% of patients. However, no placebo-controlled trials have assessed the efficacy or safety of modern antidepressants in combination with mood stabilizers in the maintenance treatment of BD. The investigators propose a multicentre, randomized, double-blind clinical trial comparing mood stabilizer plus antidepressant (escitalopram or bupropion XL) to mood stabilizer plus placebo in the maintenance treatment of BD. The investigators hypothesize that in clinically representative patients with bipolar disorder, who respond to acute treatment with a newer antidepressant medication in conjunction with a mood stabilizing medication, continuing the antidepressant for 12 months will reduce the risk of relapse into any mood episode, including depression, mania, and hypomania, compared to stopping the antidepressant after 8 weeks.

Timeline

Start

2010-11

Primary completion

2020-03-31

Completion

2020-05-20

Publications

• Yatham LN, Arumugham SS, Kesavan M, Ramachandran K, Murthy NS, Saraf G, Ouyang Y, Bond DJ, Schaffer A, Ravindran A, Ravindran N, Frey BN, Daigneault A, Beaulieu S, Lam RW, Kondapuram N, Reddy MS, Bhandary RP, Ashok MV, Ha K, Ahn YM, Milev R, Wong H, Reddy YCJ; BEAM-BD Trial Group. Duration of Adjunctive Antidepressant Maintenance in Bipolar I Depression. N Engl J Med. 2023 Aug 3;389(5):430-440. doi: 10.1056/NEJMoa2300184.

Drugs

Indications