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Phase III/Seroquel SR Bipolar Depression Monotherapy - US

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ClinicalTrials.gov Identifier: NCT00422214
Recruitment Status : Completed
First Posted : January 15, 2007
Last Update Posted : March 25, 2009
Information provided by:

Brief Summary:

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : December 2006
Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00422214

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

ClinicalTrials.gov Identifier: NCT00422214     History of Changes
Other Study ID Numbers: D144CC00002
First Posted: January 15, 2007    Key Record Dates
Last Update Posted: March 25, 2009
Last Verified: March 2009

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

Additional relevant MeSH terms:
Depressive Disorder
Psychotic Disorders
Mental Disorders
Bipolar Disorder
Affective Disorders, Psychotic
Behavioral Symptoms
Mood Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Bipolar and Related Disorders
Quetiapine Fumarate
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs