Seroquel in Bipolar Depression versus Lithium

Study identifier:D1447C00001

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

Multi-centre, Double-blind, Randomised, Parallel-group, Placebo-controlled, Phase 3 study of the Efficacy & Safety of Quetiapine Fumarate & Lithium as Monotherapy in Adult Patients with Bipolar Depression for 8 weeks & Quetiapine in Continuation (abbreviated)

Medical condition

Bipolar Disorder

Phase

Phase 3

Healthy volunteers

No

Study drug

Quetiapine Fumarate (Seroquel™) drug, mood stabilizer (mood)

Sex

All

Actual Enrollment

672

Study type

Interventional

Age

18 Years - 65 Years

Date

Study Start Date: 01 Aug 2005
Primary Completion Date: -
Study Completion Date: 01 May 2007

Study design

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Nov 2013 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria