Quetiapine Fumarate Bipolar Maintenance Monotherapy (SPaRCLe)

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

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 Intervention Phase
Bipolar Disorder
Drug: quetiapine fumarate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

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

Secondary Outcome Measures:
  • Time from randomization to recurrence of a manic event
  • Time from randomization to recurrence of a depressed event

Enrollment: 1255
Study Start Date: March 2005
Study Completion Date: July 2007
Intervention Details:
    Drug: quetiapine fumarate
    Other Name: Seroquel

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  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: NCT00314184

  Show 95 Study Locations
Sponsors and Collaborators
Study Director: AstraZeneca CNS Medical Science Director, MD AstraZeneca
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00314184     History of Changes
Other Study ID Numbers: D1447C00144  EUDRACT 2004-000915-25 
Study First Received: April 11, 2006
Last Updated: December 19, 2008
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Bulgaria: Bulgarian Drug Agency
Chile: Instituto de Salud Pública de Chile
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
India: Ministry of Health
Lithuania: State Medicine Control Agency - Ministry of Health
Malaysia: Ministry of Health
Mexico: Federal Commission for Protection Against Health Risks
Peru: General Directorate of Pharmaceuticals, Devices, and Drugs
Philippines: Bureau of Food and Drugs
Romania: State Institute for Drug Control
Russia: Pharmacological Committee, Ministry of Health
Taiwan: Department of Health
Ukraine: State Pharmacological Center - Ministry of Health

Keywords provided by AstraZeneca:
Bipolar I disorder.

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

ClinicalTrials.gov processed this record on May 26, 2016