Citalopram for Acute and Preventive Efficacy in Bipolar Depression (CAPE-BD): A Randomized, Double-Blind, Placebo-Controlled Trial

Abstract

Objective: To assess the efficacy and safety of citalopram in the acute and maintenance phases of bipolar depression in a randomized, double-blind, placebo-controlled trial. Method: 119 subjects with acute major depressive episodes diagnosed with bipolar disorder, type I or type II, were randomized blindly to citalopram versus placebo, added to standard mood stabilizers. They were followed for 6 weeks for acute efficacy (primary outcome) and up to one year for maintenance efficacy (secondary outcome), using Montgomery Asberg Depression Scale (MADRS) and Mania Rating Scale (MRS) scores. The study was powered for a clinically meaningful effect size. Results: MADRS scores changed from baseline of 27.4 ± 9.1 to 13.1 ± 8.4 for citalopram versus 27.4 ± 7.3 to 15.2 ± 9.9 for placebo, a clinically and statistically non-significant difference. Maintenance efficacy also was not better with citalopram than placebo. Acute manic/hypomanic episodes were similar in both groups, and type II subjects did not have better outcomes than type I subjects. In maintenance treatment, MRS scores were greater overall, especially in rapid-cycling subjects, with citalopram versus placebo. Conclusion: Citalopram, added to standard mood stabilizers, did not have clinically meaningful benefit versus placebo for both acute and maintenance treatment of bipolar depression. Acute mania did not worsen with citalopram, but maintenance treatment led to worsened manic symptoms, especially in rapid-cycling subjects.