Quetiapine Fumarate (SEROQUEL) Compared to Placebo in the Treatment of Children & Adolescents with Bipolar I Mania - ANCHOR 149

Study identifier:D1441C00149

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A 3-wk, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Phase 3b Study of the Efficacy & Safety of Quetiapine Fumarate (SEROQUEL™) Immediate-release Tablets in the Treatment of Children & Adolescents with Bipolar I Mania (abbreviated)

Medical condition

Bipolar Disorder

Phase

Phase 3

Healthy volunteers

No

Study drug

quetiapine fumarate

Sex

All

Actual Enrollment

220

Study type

Interventional

Age

10 Years - 17 Years

Date

Study Start Date: 01 Jul 2004
Primary Completion Date: -
Study Completion Date: 01 Jul 2006

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