Quetiapine Fumarate Bipolar Maintenance Monotherapy

Bipolar Disorder Clinical Trial

— SPaRCLe  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00314184
• Other study ID #: D1447C00144
• Secondary ID: EUDRACT 2004-000
• Status: Completed
• Phase: Phase 3
• First received: April 11, 2006
• Last updated: December 19, 2008
• Start date: March 2005
• Est. completion date: July 2007

Study information

• Verified date: December 2008
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaBulgaria: Bulgarian Drug AgencyChile: Instituto de Salud Pública de ChileColombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y AlimentosIndia: Ministry of HealthLithuania: State Medicine Control Agency - Ministry of HealthMalaysia: Ministry of HealthMexico: Federal Commission for Protection Against Health RisksPeru: General Directorate of Pharmaceuticals, Devices, and DrugsPhilippines: Bureau of Food and DrugsRomania: State Institute for Drug ControlRussia: Pharmacological Committee, Ministry of HealthTaiwan: Department of HealthUkraine: State Pharmacological Center - Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1255
• Est. completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

Drug:
• quetiapine fumarate

Locations

Country	Name	City	State
Argentina	Research Site	Capital Federal
Argentina	Research Site	Cordoba
Argentina	Research Site	La Plata
Argentina	Research Site	Lanus
Argentina	Research Site	Mendoza
Argentina	Research Site	Rosario
Bulgaria	Research Site	Bourgas
Bulgaria	Research Site	Plovdiv
Bulgaria	Research Site	Sofia
Colombia	Research Site	Antioquia
Colombia	Research Site	Barranquilla
Colombia	Research Site	Bogota
Colombia	Research Site	Pereira
India	Research Site	Ahmedabad
India	Research Site	Chennai
India	Research Site	Jaipur
India	Research Site	Kanpur
India	Research Site	Lucknow
India	Research Site	Mangalore
India	Research Site	Manipal
India	Research Site	Mumbai
India	Research Site	New Delhi
India	Research Site	Visakhapatnam
Lithuania	Research Site	Kaunas
Lithuania	Research Site	Klaipeda
Lithuania	Research Site	Vilnius
Malaysia	Research Site	Kuala Lumpur
Malaysia	Research Site	Sarawak
Mexico	Research Site	Leon
Mexico	Research Site	Mexico
Mexico	Research Site	San Luis Potosi
Peru	Research Site	Lima
Philippines	Research Site	Cebu City
Philippines	Research Site	Davao City
Philippines	Research Site	Mandaluyong City
Philippines	Research Site	Manila
Philippines	Research Site	Quezon City
Romania	Research Site	Arad
Romania	Research Site	Brasov
Romania	Research Site	Bucuresti
Romania	Research Site	Cluj-Napoca
Romania	Research Site	Com Jebel
Romania	Research Site	Craiova
Romania	Research Site	Iasi
Romania	Research Site	Oradea
Romania	Research Site	Pitesti
Romania	Research Site	Sibiu
Romania	Research Site	Targoviste
Romania	Research Site	Targu Mures
Russian Federation	Research Site	Kazan
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	St. Petersburg
Taiwan	Research Site	Kaohsiung Hsien
Taiwan	Research Site	Taipei
Taiwan	Research Site	Taoyuan City
Taiwan	Research Site	Taoyuan Hsien
Thailand	Research Site	Bangkok
Ukraine	Research Site	Dnepropetrovsk
Ukraine	Research Site	Kharkiv
Ukraine	Research Site	Kiev
Ukraine	Research Site	Kyiv
Ukraine	Research Site	Lviv
Ukraine	Research Site	Odessa
Ukraine	Research Site	Simferopol
Ukraine	Research Site	Vinnitsa
United States	Research Site	Atlanta	Georgia
United States	Research Site	Austin	Texas
United States	Research Site	Bellevue	Washington
United States	Research Site	Cerritos	California
United States	Research Site	Clementon	New Jersey
United States	Research Site	Eagle	Idaho
United States	Research Site	Fargo	North Dakota
United States	Research Site	Flowood	Mississippi
United States	Research Site	Gainesville	Florida
United States	Research Site	Hoffman Estates	Illinois
United States	Research Site	Jacksonville	Florida
United States	Research Site	Kirkland	Washington
United States	Research Site	Lake Jackson	Texas
United States	Research Site	Las Vegas	Nevada
United States	Research Site	Memphis	Tennessee
United States	Research Site	North Miami	Florida
United States	Research Site	Orlando	Florida
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Portland	Oregon
United States	Research Site	Raleigh	North Carolina
United States	Research Site	Richmond	Virginia
United States	Research Site	Rochester	New York
United States	Research Site	Salem	Oregon
United States	Research Site	San Diego	California
United States	Research Site	Santa Ana	California
United States	Research Site	Seattle	Washington
United States	Research Site	Shreveport	Louisiana
United States	Research Site	St. Charles	Missouri
United States	Research Site	Terre Haute	Indiana
United States	Research Site	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Argentina,  Bulgaria,  Colombia,  India,  Lithuania,  Malaysia,  Mexico,  Peru,  Philippines,  Romania,  Russian Federation,  Taiwan,  Thailand,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time from randomization to recurrence of a mood event
Secondary	Time from randomization to recurrence of a manic event
Secondary	Time from randomization to recurrence of a depressed event

External Links

•   AstraZeneca Clinical Trial Information - Outside US