Seroquel in Bipolar Depression Versus Lithium

NCT00206141 ↗

Phase 3 Completed 672 enrolled AstraZeneca

RandomizedParallel-groupDouble-blindTreatment

Summary

This study is being carried out to see if quetiapine fumarate (Seroquel) is effective in treating bipolar depression during an 8-week acute phase compared with placebo and lithium, followed by continuation treatment for 26 up to 52 with quetiapine fumarate (Seroquel) compared to placebo.

Timeline

Start: 2005-08
Primary completion: —
Completion: 2007-05

Outcome

Met primary endpoint

paper P < .001 for both quetiapine doses, P = .123 for lithium, vs placebo). PMID 20122369 ↗

paper Quetiapine (300 or 600 mg/d) was more effective than placebo for the treatment of episodes of acute depression in bipolar disorder. PMID 20122369 ↗

Publications

Young AH, McElroy SL, Bauer M, Philips N, Chang W, Olausson B, Paulsson B, Brecher M; EMBOLDEN I (Trial 001) Investigators. A double-blind, placebo-controlled study of quetiapine and lithium monotherapy in adults in the acute phase of bipolar depression (EMBOLDEN I). J Clin Psychiatry. 2010 Feb;71(2):150-62. doi: 10.4088/JCP.08m04995gre. Epub 2010 Jan 26.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Quetiapine	Small molecule	300 mg	—
Subject	Quetiapine	Small molecule	600 mg	—