Phase III/Seroquel SR Bipolar Depression Monotherapy - US

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00422214
First received: January 12, 2007
Last updated: March 24, 2009
Last verified: March 2009
  Purpose

The purpose of this study is to determine the safety and efficacy of sustained-release quetiapine fumarate (Seroquel®) in the treatment of patients with Acute Bipolar Depression for 8 weeks.

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


Condition Intervention Phase
Affective Psychosis, Bipolar
Depression, Bipolar
Manic-Depressive Psychosis
Psychoses, Manic-Depressive
Drug: Quetiapine fumarate (Seroquel) SR
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo-Controlled, Phase III Study of the Efficacy and Safety of Quetiapine Fumarate (Seroquel SR®) Sustained-Release as Monotherapy in Adult Patients With Acute Bipolar Depression

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Change from baseline in depression symptoms by final visit as measured by the MADRS total score

Secondary Outcome Measures:
  • Change from baseline to final visit on the MADRS total score MADRS item scores, CGI-BP-S, CGI-BP-C

Estimated Enrollment: 400
Study Start Date: December 2006
Study Completion Date: June 2007
  Eligibility

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

Inclusion Criteria:

  • Provision of written informed consent
  • Documented diagnosis of Bipolar 1 disorder or Bipolar 11 disorder
  • Outpatient status at enrollment

Exclusion Criteria:

  • Patients with >8 mood episodes during the past 12 years
  • Use of prohibited medications
  • Substance or alcohol abuse or dependence
  • Current suicide risk or suicide attempt within last 6 months.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00422214

  Show 54 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Catherine Datto, MD AstraZeneca
Study Director: Larisa Acevedo, Ph.D AstraZeneca
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00422214     History of Changes
Other Study ID Numbers: D144CC00002
Study First Received: January 12, 2007
Last Updated: March 24, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Bipolar Disorder
Bipolar Depression,
Manic Depression
Seroquel
Seroquel SR
quetiapine fumarate

Additional relevant MeSH terms:
Affective Disorders, Psychotic
Bipolar Disorder
Depression
Depressive Disorder
Mental Disorders
Psychotic Disorders
Depressive Disorder, Major
Mood Disorders
Behavioral Symptoms
Schizophrenia and Disorders with Psychotic Features
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 July 29, 2014