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Efficacy and Safety of Seroquel Plus Mood Stabilizer in the Maintenance of Bipolar I Disorder

NCT00081380 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 710

Last updated 2008-12-22

No results posted yet for this study

Summary

The purpose of this study is to determine whether quetiapine when used as adjunct to lithium or divalproex is safe and effective in the maintenance treatment of adult patients with Bipolar I Disorder. The study consists of enrollment and 2 phases, the Open-label treatment Phase and the Randomized treatment Phase.

PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.

Conditions

Interventions

DRUG

Seroquel®, quetiapine fumarate (atypical antipsychotic)

DRUG

lithium (mood stabilizer)

DRUG

divalproex (mood stabilizer)

Sponsors & Collaborators

Principal Investigators

  • AstraZeneca Seroquel Medical Science Director, MD · AstraZeneca

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-03-31
Completion
2006-09-30

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00081380 on ClinicalTrials.gov