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Sarasota, Florida

  • Bipolar I Disorder

Purpose:

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.


Criteria:

Inclusion Criteria: - A diagnosis of Bipolar I Disorder, Most recent episode Manic (296.4x), or Bipolar I Disorder, Most Recent Episode Depressed (296.5x), or Bipolar I Disorder, Most recent Episode Mixed (296.6x), with or without psychotic features, as defined by Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition (DSM-IV) - At least 1 manic, depressed, or mixed episode in the 2 years prior to the index episode. - Able to understand and comply with the requirements of the study. Exclusion Criteria: - Diagnosis of an anxiety disorder as defined by DSM-IV, which was treated with medication within the past year. - Known intolerance or lack of response to quetiapine fumarate or to the assigned mood stabilizer, as judged by the investigator. - Previously randomized into this study or D1447C00126


Study is Available At:


Original ID:

D1447C00126


NCT ID:

NCT00107731


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

A Multicenter, Randomized, Parallel-Group, Double-Blind, Phase 3 Comparison of the Efficacy & Safety of Quetiapine Fumarate to Placebo When Used as Adjunct to Mood Stabilizers (Lithium or Valproate) in the Maintenance Treatment of Bipolar I Disorder i


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

AstraZeneca


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

710


Enrollment Type:


Overall Contact Information

Official Name:AstraZeneca Seroquel Medical Science Director, MD
Study Director
AstraZeneca

Study Dates

Start Date:April 2004
Completion Date:October 2006
Completion Type:Actual
Verification Date:March 2009
Last Changed Date:March 24, 2009
First Received Date:April 7, 2005

Study Outcomes

Outcome Type:Primary Outcome
Measure:Evaluate the efficacy of quetiapine versus placebo when used as adjunct therapy to mood stabilizer in increasing time to recurrence of a mood event.
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Evaluate the efficacy of quetiapine versus placebo when used as a adjunct therapy to mod stabilizer in increasing time to recurrence of a manic event
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:quetiapine fumarate
Intervention Type:Drug
Name:lithium
Intervention Type:Drug
Name:divalproex

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:AstraZeneca

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: April 03, 2020

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