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Controlled Study of the Use of Quetiapine Fumarate in the Treatment of Patients With Bipolar Depression

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00083954
First received: June 3, 2004
Last updated: January 3, 2013
Last verified: January 2013
History of Changes
  Purpose

The purpose of this study is to determine the efficacy of quetiapine compared to placebo in the treatment for a major depressive episode in patients with bipolar disorder after receiving treatment for up to 8 weeks.


Condition Intervention Phase
Bipolar Disorder
 Drug: Quetiapine Fumarate
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Confirmatory Multicenter, Double-blind, Randomized, Placebo Controlled Study of the Use of Quetiapine Fumarate (SEROQUEL) in the Treatment of Patients With Bipolar Depression

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Change from baseline to week 8 in the Montgomery-Asberg Depression Rating Scale (MADRS) total score

Secondary Outcome Measures:
  • Evaluate the incidence of treatment-emergent mania compared to placebo

Estimated Enrollment: 530
Study Start Date: June 2004
Study Completion Date: August 2005
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Provision of informed consent before enrollment and any study-specific procedures. Patients deemed incapable of providing written consent will not be enrolled in this study; outpatient status

Exclusion Criteria:

  • More than 8 mood episodes in the past year from screen (visit 1);
  • A current Axis I disorder other than bipolar disorder within 6 months of screening;
  • patients with clinically significant abnormal laboratory findings in the investigator's judgment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00083954

  Show 36 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca Seroquel Medical Science Director, MD AstraZeneca
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00083954     History of Changes
Other Study ID Numbers: D1447C00135
Study First Received: June 3, 2004
Last Updated: January 3, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Bipolar I Disorder

Additional relevant MeSH terms:
Bipolar Disorder
Depression
Depressive Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Behavioral Symptoms
Quetiapine
 Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on June 18, 2013