Overview

Quetiapine Fumarate (Seroquel) as Mono-Therapy or Adjunct to Lithium in the Treatment of Patients With Acute Mania in Bipolar Disorder

Status:
Completed

Trial end date:
2009-07-01

Target enrollment:

Participant gender:

Summary

To compare the efficacy and safety of quetiapine fumarate given as mono-therapy or adjunct therapy to lithium in the treatment of patients with acute mania in bipolar disorder. Patients with a documented clinical diagnosis of bipolar mania according to DSM-IV criteria (296.4X Bipolar I Disorder, Most Recent Episode Manic; 296.0X Bipolar I Disorder, Single Manic Episode) are required to have a YMRS total score of ≥20 at enrolment and randomisation

Phase:

Phase 4

Details

Lead Sponsor:

AstraZeneca

Treatments:

Lithium Carbonate
Quetiapine Fumarate