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Quetiapine Fumarate Bipolar Maintenance Monotherapy (SPaRCLe)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00314184
Recruitment Status : Completed
First Posted : April 13, 2006
Last Update Posted : December 22, 2008
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Brief Summary:

This is a multicenter, randomized, parallel-group, double-blind, placebo-controlled study to evaluate the efficacy and safety of quetiapine and lithium (comparator in the study) for up to 104 weeks of maintenance treatment in adult patients with Bipolar I Disorder.

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
Bipolar Disorder Drug: quetiapine fumarate Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1255 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multicenter, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Phase 3 Study of the Efficacy and Safety of Quetiapine Fumarate and Lithium as Monotherapy for up to 104 Weeks Maintenance Treatment of Bipolar I Disorder in Adult Patients
Study Start Date : March 2005
Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    Drug: quetiapine fumarate
    Other Name: Seroquel

Primary Outcome Measures :
  1. Time from randomization to recurrence of a mood event

Secondary Outcome Measures :
  1. Time from randomization to recurrence of a manic event
  2. Time from randomization to recurrence of a depressed event

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Signed informed consent
  • 18 years or older
  • A diagnosis of Bipolar I Disorder
  • Have a current manic, depressed or mixed episode
  • Have had a manic, depressed or mixed episode during the last 26 weeks that was treated with quetiapine
  • Female patients of childbearing potential must be using a reliable method of contraception

Exclusion Criteria:

  • Pregnancy
  • Substance or alcohol dependence at enrollment
  • Unstable thyroid function
  • Unstable Diabetes
  • Unstable or inadequately treated medical illness e.g., angina pectoris and hypertension
  • Use of an experimental drug within 30 days of enrollment

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 identifier (NCT number): NCT00314184

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Sponsors and Collaborators
Study Director: AstraZeneca CNS Medical Science Director, MD AstraZeneca

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00314184     History of Changes
Other Study ID Numbers: D1447C00144
EUDRACT 2004-000915-25
First Posted: April 13, 2006    Key Record Dates
Last Update Posted: December 22, 2008
Last Verified: December 2008

Keywords provided by AstraZeneca:
Bipolar I disorder.

Additional relevant MeSH terms:
Bipolar Disorder
Bipolar and Related Disorders
Mental Disorders
Quetiapine Fumarate
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs