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Quetiapine Fumarate Bipolar Maintenance Monotherapy (SPaRCLe)
This study has been completed.
Sponsored by: AstraZeneca
Information provided by: AstraZeneca
ClinicalTrials.gov Identifier: NCT00314184
  Purpose

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 III

MedlinePlus related topics: Bipolar Disorder
Drug Information available for: Quetiapine Quetiapine fumarate Lithium carbonate Lithium citrate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00314184

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

AstraZeneca Clinical Trial Information - Outside US  This link exits the ClinicalTrials.gov site

Study ID Numbers: D1447C00144, EUDRACT 2004-000915-25
Study First Received: April 11, 2006
Last Updated: December 19, 2008
ClinicalTrials.gov Identifier: NCT00314184  
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica;   Bulgaria: Bulgarian Drug Agency;   Chile: Instituto de Salud Publica 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.

Study placed in the following topic categories:
Quetiapine
Affective Disorders, Psychotic
Mental Disorders
Bipolar Disorder
 Mood Disorders
Lithium Carbonate
Psychotic Disorders
Lithium

Additional relevant MeSH terms:
Tranquilizing Agents
Pathologic Processes
Disease
Therapeutic Uses
Physiological Effects of Drugs
 Psychotropic Drugs
Central Nervous System Depressants
Antipsychotic Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009



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