Mood Stabilizer (MS)+ Antidepressant vs MS + Placebo in Maintenance of Bipolar Disorder.
Status:
Completed
Trial end date:
2020-03-31
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
University of British Columbia
Collaborators:
Canadian Institutes of Health Research (CIHR) GlaxoSmithKline Lundbeck Canada Inc.