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Study of Aripiprazole in Patients With Bipolar I Disorder

Primary Purpose

Bipolar Disorder

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
aripiprazole
Sponsored by
Otsuka Pharmaceutical Development & Commercialization, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Disorder focused on measuring Bipolar Mania

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Clinical diagnosis of bipolar I disorder, manic or mixed episode Exclusion Criteria: First manic or mixed episode Allergic, intolerant, or unresponsive to lithium and valproate or to aripiprazole Participation in a previous clinical trial within the past month or ever participated in a trial with aripiprazole

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Outcomes

Primary Outcome Measures

Change from baseline to endpoint in a mania rating scale

Secondary Outcome Measures

Response rate and Clinical Global Impression Scale at endpoint

Full Information

First Posted
November 23, 2005
Last Updated
November 7, 2013
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborators
Otsuka America Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT00257972
Brief Title
Study of Aripiprazole in Patients With Bipolar I Disorder
Official Title
Efficacy of Aripiprazole in Combination With Valproate or Lithium in the Treatment of Mania in Patients With Bipolar I Disorder Partially Nonresponsive to Valproate or Lithium Monotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborators
Otsuka America Pharmaceutical

4. Oversight

5. Study Description

Brief Summary
The purpose of this research study is to compare the efficacy of aripiprazole with placebo in combination with lithium or valproate monotherapy, in the treatment of bipolar I patients with manic or mixed episodes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder
Keywords
Bipolar Mania

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
400 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
aripiprazole
Primary Outcome Measure Information:
Title
Change from baseline to endpoint in a mania rating scale
Secondary Outcome Measure Information:
Title
Response rate and Clinical Global Impression Scale at endpoint

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of bipolar I disorder, manic or mixed episode Exclusion Criteria: First manic or mixed episode Allergic, intolerant, or unresponsive to lithium and valproate or to aripiprazole Participation in a previous clinical trial within the past month or ever participated in a trial with aripiprazole
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution
City
Little Rock
State/Province
Arkansas
Country
United States
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Local Institution
City
Riverside
State/Province
California
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United States
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Deerfield Beach
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Florida
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United States
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Jacksonville
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Florida
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United States
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Maitland
State/Province
Florida
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United States
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Local Institution
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Hoffman Estates
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Illinois
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United States
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Local Institution
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Oakbrook
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Illinois
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United States
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Newton
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Kansas
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United States
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Newton
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Massachusetts
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United States
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New York
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New York
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United States
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Staten Island
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New York
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United States
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Raleigh
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North Carolina
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United States
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Dayton
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Ohio
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United States
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Media
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Pennsylvania
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United States
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Norristown
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Pennsylvania
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United States
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Philadelphia
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Pennsylvania
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United States
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Columbia
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South Carolina
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United States
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Memphis
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Tennessee
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United States
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Austin
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Texas
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United States
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Bellevue
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Washington
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United States
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Epping
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Victoria
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Australia
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Rousse
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Bulgaria
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Sofia
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Bulgaria
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Varna
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Bulgaria
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Brno - Bohunice
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Czech Republic
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Hradec Kralove
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Czech Republic
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Opava
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Czech Republic
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Praha 2
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Czech Republic
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Parnu
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Estonia
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Tallinn
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Estonia
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Tartu
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Estonia
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Viljandi Maakond
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Estonia
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Voru Maakond
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Estonia
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Bordeaux
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France
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Dole
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France
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Grenoble
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France
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Jonzac Cedex
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France
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La Rochelle Cedex 1
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France
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Limoges Cedex
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France
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Marseille Cedex 05
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France
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Nimes
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France
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Pessac
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France
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Rennes Cedex
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France
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Berlin
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Germany
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Jena
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Germany
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Magdeburg
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Germany
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Meunchen
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Germany
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Westersted
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Germany
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Budapest
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Hungary
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Gyula
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Hungary
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Kecskemet
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Hungary
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Nagykallo
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Hungary
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Bassano Del Grappa
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Italy
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Cagliari
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Italy
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Firenze
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Italy
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Pisa
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Italy
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Roma
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Italy
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Sassari
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Italy
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Trieste
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Italy
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Voghera -Pavia
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Italy
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Retranchement
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Netherlands
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Zaandam
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Netherlands
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Choroszcz
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Poland
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Koscian
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Poland
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Krakow
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Poland
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Poznan
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Poland
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Torun
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Poland
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Tuszyn
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Poland
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Lisboa
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Portugal
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Lisbon
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Portugal
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Leningrad Region
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Russian Federation
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Moscow
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Russian Federation
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Saint Petersburg
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Russian Federation
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Smolensk
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Russian Federation
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Port Elizabeth
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Eastern Cape
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South Africa
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Westdene
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Free State
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South Africa
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Pretoria
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Gauteng
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South Africa
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Vereeniging
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Gauteng
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South Africa
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Welkom
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Gauteng
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South Africa
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Durban
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Kwa Zulu Natal
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South Africa
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Observatory
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Western Cape
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South Africa
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Barcelona
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Spain
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Madrid
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Spain
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Valencia
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Spain
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Vitoria
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Spain
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Herisau
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Switzerland
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Glasgow
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Dumbartonshire
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United Kingdom
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London
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Greater London
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United Kingdom
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Burnley
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Lancashire
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United Kingdom
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South Wales
State/Province
Mid Glamorgan
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United Kingdom
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Local Institution
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Surbiton
State/Province
Middlesex
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
18381903
Citation
Vieta E, T'joen C, McQuade RD, Carson WH Jr, Marcus RN, Sanchez R, Owen R, Nameche L. Efficacy of adjunctive aripiprazole to either valproate or lithium in bipolar mania patients partially nonresponsive to valproate/lithium monotherapy: a placebo-controlled study. Am J Psychiatry. 2008 Oct;165(10):1316-25. doi: 10.1176/appi.ajp.2008.07101560. Epub 2008 Apr 1.
Results Reference
background
PubMed Identifier
20429835
Citation
Vieta E, Owen R, Baudelet C, McQuade RD, Sanchez R, Marcus RN. Assessment of safety, tolerability and effectiveness of adjunctive aripiprazole to lithium/valproate in bipolar mania: a 46-week, open-label extension following a 6-week double-blind study. Curr Med Res Opin. 2010 Jun;26(6):1485-96. doi: 10.1185/03007991003779380.
Results Reference
derived

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Study of Aripiprazole in Patients With Bipolar I Disorder

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