Quetiapine Fumarate Bipolar Maintenance Monotherapy (SPaRCLe)

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00314184
First received: April 11, 2006
Last updated: December 19, 2008
Last verified: December 2008

April 11, 2006
December 19, 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 ClinicalTrials.gov Archive Site
  • Time from randomization to recurrence of a manic event
  • Time from randomization to recurrence of a depressed event
Same as current
Not Provided
Not Provided
 
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
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1255
July 2007
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Bulgaria,   Colombia,   India,   Lithuania,   Malaysia,   Mexico,   Peru,   Philippines,   Romania,   Russian Federation,   Taiwan,   Thailand,   Ukraine
 
NCT00314184
D1447C00144, EUDRACT 2004-000915-25
Not Provided
Not Provided
AstraZeneca
Not Provided
Study Director: AstraZeneca CNS Medical Science Director, MD AstraZeneca
AstraZeneca
December 2008

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