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
  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 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
  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

No publications provided by AstraZeneca

Additional 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 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.

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Quetiapine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on April 21, 2014