Efficacy & Safety of Seroquel Plus Mood Stabilizer in the Maintenance of Bipolar I Disorder

Bipolar I Disorder Clinical Trial

Official title:

A Multicenter, Randomized, Parallel-Group, Double-Blind, Phase 3 Comparison of the Efficacy & Safety of Quetiapine Fumarate to Placebo When Used as Adjunct to Mood Stabilizers (Lithium or Valproate) in the Maintenance Treatment of Bipolar I Disorder in Adult Patients (Abbreviated)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00107731
• Other study ID #: D1447C00126
• Status: Completed
• Phase: Phase 3
• First received: April 7, 2005
• Last updated: March 24, 2009
• Start date: April 2004
• Est. completion date: October 2006

Study information

• Verified date: March 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether quetiapine when used as adjunct to lithium or divalproex is safe and effective in the maintenance treatment of adult patients with Bipolar I Disorder. The study consists of enrollment and 2 phases, the Open-label treatment Phase and the Randomized treatment Phase.

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: 710
• Est. completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• A diagnosis of Bipolar I Disorder, Most recent episode Manic (296.4x), or Bipolar I Disorder, Most Recent Episode Depressed (296.5x), or Bipolar I Disorder, Most recent Episode Mixed (296.6x), with or without psychotic features, as defined by Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition (DSM-IV)

• At least 1 manic, depressed, or mixed episode in the 2 years prior to the index episode.

• Able to understand and comply with the requirements of the study.

Exclusion Criteria:

• Diagnosis of an anxiety disorder as defined by DSM-IV, which was treated with medication within the past year.

• Known intolerance or lack of response to quetiapine fumarate or to the assigned mood stabilizer, as judged by the investigator.

• Previously randomized into this study or D1447C00126

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Bipolar I Disorder
• Disease

Intervention

Drug:
• quetiapine fumarate

• lithium

• divalproex

Locations

Country	Name	City	State
Australia	Research Site	Box Hill	Victoria
Australia	Research Site	Brisbane	Queensland
Australia	Research Site	Dandenong	Victoria
Australia	Research Site	Epping	Victoria
Australia	Research Site	Everton Park	Queensland
Australia	Research Site	Glenside	South Australia
Australia	Research Site	Greenwich	New South Wales
Australia	Research Site	Richmond	Victoria
Australia	Research Site	Southport	Queensland
Belgium	Research Site	Assebroek
Belgium	Research Site	Brussels
Belgium	Research Site	Gent
Belgium	Research Site	Kortenberg
Belgium	Research Site	Manage
Belgium	Research Site	St-Denijs-Westrem
Belgium	Research Site	Waregem
Bulgaria	Research Site	Kardjali
Bulgaria	Research Site	Rousse
Bulgaria	Research Site	Sofia
Bulgaria	Research Site	Varna
Czech Republic	Research Site	Jeseník
Czech Republic	Research Site	Litomolice
Czech Republic	Research Site	Olomouc
Czech Republic	Research Site	Praha 10
Czech Republic	Research Site	Praha 2
Czech Republic	Research Site	Praha 6
Czech Republic	Research Site	Praha 8
Czech Republic	Research Site	Pterova
Finland	Research Site	Espoo
Finland	Research Site	Harjavalta
Finland	Research Site	Helsinki
Finland	Research Site	Kellokoski
Finland	Research Site	Seinajoki
France	Research Site	Besancon
France	Research Site	Bourg En Bresse
France	Research Site	La Rochelle Cedex 1
France	Research Site	Marseille Cedex 9
France	Research Site	Montpellier
France	Research Site	NIMES Cedex 4
France	Research Site	Paris Cedex 12
France	Research Site	Strasbourg Cedex
France	Research Site	Toulouse
Germany	Research Site	Augsburg
Germany	Research Site	Berlin
Germany	Research Site	Heidelberg
Germany	Research Site	Homburg
Germany	Research Site	Köln
Germany	Research Site	München
Germany	Research Site	Regensburg
Germany	Research Site	Saarbrucken
Hungary	Research Site	Budapest
Hungary	Research Site	Fuzesabony
Hungary	Research Site	Gyor
Hungary	Research Site	Kecskemet
Hungary	Research Site	Kistarcsa
Hungary	Research Site	Pecs
Italy	Research Site	Bari
Italy	Research Site	Bergamo
Italy	Research Site	Brescia
Italy	Research Site	Cagliari
Italy	Research Site	Civitanova Marche
Italy	Research Site	Firenze
Italy	Research Site	Genova
Italy	Research Site	La Spezia
Italy	Research Site	Milano
Italy	Research Site	Napoli
Italy	Research Site	Padova
Italy	Research Site	Pisa
Italy	Research Site	Roma
Italy	Research Site	Siena
Italy	Research Site	Trieste
Norway	Research Site	Bergen
Norway	Research Site	Bodo
Norway	Research Site	Bryne
Norway	Research Site	Namsos
Norway	Research Site	Oslo
Norway	Research Site	Ottestad
Norway	Research Site	Skien
Poland	Research Site	Bialystok
Poland	Research Site	Bydgoszcz
Poland	Research Site	Choroszcz
Poland	Research Site	Gdansk
Poland	Research Site	Gorlice
Poland	Research Site	Janów Lubelski
Poland	Research Site	Krakow
Poland	Research Site	Lipno
Poland	Research Site	Lodz
Poland	Research Site	Lublin
Poland	Research Site	Nowy Targ
Poland	Research Site	Poznan
Poland	Research Site	Starogard Gdanski
Poland	Research Site	Szczecin
Poland	Research Site	Torun
Poland	Research Site	Warszawa
Poland	Research Site	Zubki
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Saratov
Russian Federation	Research Site	St. Petersburg
South Africa	Research Site	Bloemfontein
South Africa	Research Site	Durban
South Africa	Research Site	Johannesburg
South Africa	Research Site	Krugersdorp
South Africa	Research Site	Pretoria
Spain	Research Site	Barcelona
Spain	Research Site	Bilbao
Spain	Research Site	Granada
Spain	Research Site	Guadalajara
Spain	Research Site	Madrid
Spain	Research Site	Oviedo
Spain	Research Site	Oviedo	Asturias
Spain	Research Site	Puerto Real	Cádiz
Spain	Research Site	Sama de Langreo	Asturias
Spain	Research Site	Santiago de Compostela
Spain	Research Site	Sevilla
Spain	Research Site	Terrassa	Barcelona
Spain	Research Site	Vigo
Sweden	Research Site	Falkoping
Sweden	Research Site	Linköping
Sweden	Research Site	Ludvika
Sweden	Research Site	Sollentuna
Sweden	Research Site	Stockholm
Sweden	Research Site	Sundsvall
Turkey	Research Site	Adana
Turkey	Research Site	Ankara
Turkey	Research Site	Istanbul
Turkey	Research Site	Izmir
United Kingdom	Research Site	Birmingham
United Kingdom	Research Site	London
United Kingdom	Research Site	Oxford
United Kingdom	Research Site	Runcorn
United Kingdom	Research Site	Ryhope
United Kingdom	Research Site	Surbiton
United Kingdom	Research Site	Welwyn Garden City
United States	Research Site	Beverly Hills	California
United States	Research Site	Birmingham	Alabama
United States	Research Site	Brooklyn	New York
United States	Research Site	Chula Vista	California
United States	Research Site	Conroe	Texas
United States	Research Site	Gainesville	Florida
United States	Research Site	Glen Burnie	Maryland
United States	Research Site	Granite City	Illinois
United States	Research Site	Havertown	Pennsylvania
United States	Research Site	Houston	Texas
United States	Research Site	Jacksonville	Florida
United States	Research Site	Kalamazoo	Michigan
United States	Research Site	Libertyville	Illinois
United States	Research Site	Media	Pennsylvania
United States	Research Site	Metairie	Louisiana
United States	Research Site	Miami	Florida
United States	Research Site	Milwaukee	Wisconsin
United States	Research Site	Morganton	North Carolina
United States	Research Site	Oklahoma City	Oklahoma
United States	Research Site	Olean	New York
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Portland	Oregon
United States	Research Site	Raleigh	North Carolina
United States	Research Site	Redlands	California
United States	Research Site	Richmond	Virginia
United States	Research Site	Rochester	New York
United States	Research Site	San Francisco	California
United States	Research Site	Santa Ana	California
United States	Research Site	Sarasota	Florida
United States	Research Site	Schaumburg	Illinois
United States	Research Site	Seattle	Washington
United States	Research Site	St. Charles	Missouri
United States	Research Site	St. Louis	Missouri
United States	Research Site	Tampa	Florida
United States	Research Site	Wichita	Kansas
United States	Research Site	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Bulgaria,  Czech Republic,  Finland,  France,  Germany,  Hungary,  Italy,  Norway,  Poland,  Russian Federation,  South Africa,  Spain,  Sweden,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the efficacy of quetiapine versus placebo when used as adjunct therapy to mood stabilizer in increasing time to recurrence of a mood event.
Secondary	Evaluate the efficacy of quetiapine versus placebo when used as a adjunct therapy to mod stabilizer in increasing time to recurrence of a manic event