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
Information provided by:

April 11, 2006
April 13, 2006
December 22, 2008
March 2005
Not Provided
Time from randomization to recurrence of a mood event
Same as current
Complete list of historical versions of study NCT00314184 on Archive Site
  • Time from randomization to recurrence of a manic event
  • Time from randomization to recurrence of a depressed event
Same as current
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Quetiapine Fumarate Bipolar Maintenance Monotherapy
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

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.

Not Provided
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Bipolar Disorder
Drug: quetiapine fumarate
Other Name: Seroquel
Not Provided
Weisler RH, Nolen WA, Neijber A, Hellqvist A, Paulsson B; Trial 144 Study Investigators. Continuation of quetiapine versus switching to placebo or lithium for maintenance treatment of bipolar I disorder (Trial 144: a randomized controlled study). J Clin Psychiatry. 2011 Nov;72(11):1452-64. doi: 10.4088/JCP.11m06878. Erratum in: J Clin Psychiatry. 2014 Mar;75(3):290.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
July 2007
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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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Colombia,   Argentina,   Bulgaria,   India,   Lithuania,   Malaysia,   Mexico,   Peru,   Philippines,   Romania,   Russian Federation,   Taiwan,   Thailand,   Ukraine,   United States
EUDRACT 2004-000915-25
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Study Director: AstraZeneca CNS Medical Science Director, MD AstraZeneca
December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP