Clinical trial NCT00107731: Efficacy & Safety of Seroquel Plus Mood Stabilizer in the Maintenance of Bipolar I Disorder
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bipolar I Disorder
Keywords: Bipolar I Disorder
Manic Depressive Disorder
Manic Depression
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-04-08
Enrollment: 710
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: 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 outcomes:
measure: 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
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Beverly Hills
country: United States
facility: Research Site
state: California
city: Chula Vista
country: United States
facility: Research Site
state: California
city: Redlands
country: United States
facility: Research Site
state: California
city: San Francisco
country: United States
facility: Research Site
state: California
city: Santa Ana
country: United States
facility: Research Site
state: California
city: Gainesville
country: United States
facility: Research Site
state: Florida
city: Jacksonville
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Research Site
state: Florida
city: Sarasota
country: United States
facility: Research Site
state: Florida
city: Tampa
country: United States
facility: Research Site
state: Florida
city: Winter Park
country: United States
facility: Research Site
state: Florida
city: Granite City
country: United States
facility: Research Site
state: Illinois
city: Libertyville
country: United States
facility: Research Site
state: Illinois
city: Schaumburg
country: United States
facility: Research Site
state: Illinois
city: Wichita
country: United States
facility: Research Site
state: Kansas
city: Metairie
country: United States
facility: Research Site
state: Louisiana
city: Glen Burnie
country: United States
facility: Research Site
state: Maryland
city: Kalamazoo
country: United States
facility: Research Site
state: Michigan
city: St. Charles
country: United States
facility: Research Site
state: Missouri
city: St. Louis
country: United States
facility: Research Site
state: Missouri
city: Brooklyn
country: United States
facility: Research Site
state: New York
city: Olean
country: United States
facility: Research Site
state: New York
city: Rochester
country: United States
facility: Research Site
state: New York
city: Morganton
country: United States
facility: Research Site
state: North Carolina
city: Raleigh
country: United States
facility: Research Site
state: North Carolina
city: Oklahoma City
country: United States
facility: Research Site
state: Oklahoma
city: Portland
country: United States
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state: Oregon
city: Havertown
country: United States
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state: Pennsylvania
city: Media
country: United States
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state: Pennsylvania
city: Philadelphia
country: United States
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state: Pennsylvania
city: Conroe
country: United States
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state: Texas
city: Houston
country: United States
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state: Texas
city: Richmond
country: United States
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state: Virginia
city: Seattle
country: United States
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state: Washington
city: Milwaukee
country: United States
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state: Wisconsin
city: Greenwich
country: Australia
facility: Research Site
state: New South Wales
city: Brisbane
country: Australia
facility: Research Site
state: Queensland
city: Everton Park
country: Australia
facility: Research Site
state: Queensland
city: Southport
country: Australia
facility: Research Site
state: Queensland
city: Glenside
country: Australia
facility: Research Site
state: South Australia
city: Box Hill
country: Australia
facility: Research Site
state: Victoria
city: Dandenong
country: Australia
facility: Research Site
state: Victoria
city: Epping
country: Australia
facility: Research Site
state: Victoria
city: Richmond
country: Australia
facility: Research Site
state: Victoria
city: Assebroek
country: Belgium
facility: Research Site
city: Brussels
country: Belgium
facility: Research Site
city: Gent
country: Belgium
facility: Research Site
city: Kortenberg
country: Belgium
facility: Research Site
city: Manage
country: Belgium
facility: Research Site
city: St-Denijs-Westrem
country: Belgium
facility: Research Site
city: Waregem
country: Belgium
facility: Research Site
city: Kardjali
country: Bulgaria
facility: Research Site
city: Rousse
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Varna
country: Bulgaria
facility: Research Site
city: Jeseník
country: Czech Republic
facility: Research Site
city: Litomolice
country: Czech Republic
facility: Research Site
city: Olomouc
country: Czech Republic
facility: Research Site
city: Praha 10
country: Czech Republic
facility: Research Site
city: Praha 2
country: Czech Republic
facility: Research Site
city: Praha 6
country: Czech Republic
facility: Research Site
city: Praha 8
country: Czech Republic
facility: Research Site
city: Pterova
country: Czech Republic
facility: Research Site
city: Espoo
country: Finland
facility: Research Site
city: Harjavalta
country: Finland
facility: Research Site
city: Helsinki
country: Finland
facility: Research Site
city: Kellokoski
country: Finland
facility: Research Site
city: Seinajoki
country: Finland
facility: Research Site
city: Besancon
country: France
facility: Research Site
city: Bourg En Bresse
country: France
facility: Research Site
city: La Rochelle Cedex 1
country: France
facility: Research Site
city: Marseille Cedex 9
country: France
facility: Research Site
city: Montpellier
country: France
facility: Research Site
city: NIMES Cedex 4
country: France
facility: Research Site
city: Paris Cedex 12
country: France
facility: Research Site
city: Strasbourg Cedex
country: France
facility: Research Site
city: Toulouse
country: France
facility: Research Site
city: Augsburg
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Heidelberg
country: Germany
facility: Research Site
city: Homburg
country: Germany
facility: Research Site
city: Köln
country: Germany
facility: Research Site
city: München
country: Germany
facility: Research Site
city: Regensburg
country: Germany
facility: Research Site
city: Saarbrucken
country: Germany
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Fuzesabony
country: Hungary
facility: Research Site
city: Gyor
country: Hungary
facility: Research Site
city: Kecskemet
country: Hungary
facility: Research Site
city: Kistarcsa
country: Hungary
facility: Research Site
city: Pecs
country: Hungary
facility: Research Site
city: Bari
country: Italy
facility: Research Site
city: Bergamo
country: Italy
facility: Research Site
city: Brescia
country: Italy
facility: Research Site
city: Cagliari
country: Italy
facility: Research Site
city: Civitanova Marche
country: Italy
facility: Research Site
city: Firenze
country: Italy
facility: Research Site
city: Genova
country: Italy
facility: Research Site
city: La Spezia
country: Italy
facility: Research Site
city: Milano
country: Italy
facility: Research Site
city: Napoli
country: Italy
facility: Research Site
city: Padova
country: Italy
facility: Research Site
city: Pisa
country: Italy
facility: Research Site
city: Roma
country: Italy
facility: Research Site
city: Siena
country: Italy
facility: Research Site
city: Trieste
country: Italy
facility: Research Site
city: Bergen
country: Norway
facility: Research Site
city: Bodo
country: Norway
facility: Research Site
city: Bryne
country: Norway
facility: Research Site
city: Namsos
country: Norway
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city: Oslo
country: Norway
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city: Ottestad
country: Norway
facility: Research Site
city: Skien
country: Norway
facility: Research Site
city: Bialystok
country: Poland
facility: Research Site
city: Bydgoszcz
country: Poland
facility: Research Site
city: Choroszcz
country: Poland
facility: Research Site
city: Gdansk
country: Poland
facility: Research Site
city: Gorlice
country: Poland
facility: Research Site
city: Janów Lubelski
country: Poland
facility: Research Site
city: Krakow
country: Poland
facility: Research Site
city: Lipno
country: Poland
facility: Research Site
city: Lodz
country: Poland
facility: Research Site
city: Lublin
country: Poland
facility: Research Site
city: Nowy Targ
country: Poland
facility: Research Site
city: Poznan
country: Poland
facility: Research Site
city: Starogard Gdanski
country: Poland
facility: Research Site
city: Szczecin
country: Poland
facility: Research Site
city: Torun
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Zubki
country: Poland
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Saratov
country: Russian Federation
facility: Research Site
city: St. Petersburg
country: Russian Federation
facility: Research Site
city: Bloemfontein
country: South Africa
facility: Research Site
city: Durban
country: South Africa
facility: Research Site
city: Johannesburg
country: South Africa
facility: Research Site
city: Krugersdorp
country: South Africa
facility: Research Site
city: Pretoria
country: South Africa
facility: Research Site
city: Oviedo
country: Spain
facility: Research Site
state: Asturias
city: Sama de Langreo
country: Spain
facility: Research Site
state: Asturias
city: Terrassa
country: Spain
facility: Research Site
state: Barcelona
city: Puerto Real
country: Spain
facility: Research Site
state: Cádiz
city: Barcelona
country: Spain
facility: Research Site
city: Bilbao
country: Spain
facility: Research Site
city: Granada
country: Spain
facility: Research Site
city: Guadalajara
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Oviedo
country: Spain
facility: Research Site
city: Santiago de Compostela
country: Spain
facility: Research Site
city: Sevilla
country: Spain
facility: Research Site
city: Vigo
country: Spain
facility: Research Site
city: Falkoping
country: Sweden
facility: Research Site
city: Linköping
country: Sweden
facility: Research Site
city: Ludvika
country: Sweden
facility: Research Site
city: Sollentuna
country: Sweden
facility: Research Site
city: Stockholm
country: Sweden
facility: Research Site
city: Sundsvall
country: Sweden
facility: Research Site
city: Adana
country: Turkey
facility: Research Site
city: Ankara
country: Turkey
facility: Research Site
city: Istanbul
country: Turkey
facility: Research Site
city: Izmir
country: Turkey
facility: Research Site
city: Birmingham
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: Oxford
country: United Kingdom
facility: Research Site
city: Runcorn
country: United Kingdom
facility: Research Site
city: Ryhope
country: United Kingdom
facility: Research Site
city: Surbiton
country: United Kingdom
facility: Research Site
city: Welwyn Garden City
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Seroquel Medical Science Director, MD
role: STUDY_DIRECTOR
References:
citation: Suppes T, Vieta E, Gustafsson U, Ekholm B. Maintenance treatment with quetiapine when combined with either lithium or divalproex in bipolar I disorder: analysis of two large randomized, placebo-controlled trials. Depress Anxiety. 2013 Nov;30(11):1089-98. doi: 10.1002/da.22136. Epub 2013 Jun 12.