Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00257972




Registration number
NCT00257972
Ethics application status
Date submitted
23/11/2005
Date registered
24/11/2005
Date last updated
8/11/2013

Titles & IDs
Public title
Study of Aripiprazole in Patients With Bipolar I Disorder
Scientific 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
Secondary ID [1] 0 0
CN138-134
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bipolar Disorder 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Other mental health disorders
Mental Health 0 0 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from baseline to endpoint in a mania rating scale
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Response rate and Clinical Global Impression Scale at endpoint
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
* Clinical diagnosis of bipolar I disorder, manic or mixed episode
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2007
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Local Institution - Epping
Recruitment postcode(s) [1] 0 0
- Epping
Recruitment outside Australia
Country [1] 0 0
United States of America
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Arkansas
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United States of America
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California
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United States of America
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Florida
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United States of America
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Illinois
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Kansas
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United States of America
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Massachusetts
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New York
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United States of America
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North Carolina
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United States of America
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Ohio
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Pennsylvania
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South Carolina
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United States of America
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Tennessee
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United States of America
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Texas
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United States of America
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Washington
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Bulgaria
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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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Czech Republic
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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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Estonia
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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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France
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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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Germany
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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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Hungary
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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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Italy
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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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Netherlands
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Retranchement
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Netherlands
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Zaandam
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Poland
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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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Poznan
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Torun
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Poland
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Tuszyn
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Portugal
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Lisboa
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Portugal
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Lisbon
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Russian Federation
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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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South Africa
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Eastern Cape
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South Africa
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Free State
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South Africa
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Gauteng
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South Africa
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Kwa Zulu Natal
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South Africa
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Western Cape
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Spain
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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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Switzerland
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Herisau
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United Kingdom
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Dumbartonshire
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United Kingdom
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Greater London
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United Kingdom
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Lancashire
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United Kingdom
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Mid Glamorgan
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United Kingdom
State/province [82] 0 0
Middlesex

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Otsuka Pharmaceutical Development & Commercialization, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Otsuka America Pharmaceutical
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00257972