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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
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United States of America
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Arkansas
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California
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Illinois
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Kansas
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Massachusetts
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New York
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North Carolina
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Ohio
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Pennsylvania
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South Carolina
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Tennessee
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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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France
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Bordeaux
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France
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Dole
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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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Marseille Cedex 05
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France
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Nimes
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Pessac
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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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Netherlands
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Retranchement
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Zaandam
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Choroszcz
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Poland
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Koscian
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Krakow
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Poznan
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Torun
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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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Madrid
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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
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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
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.
Trial website
https://clinicaltrials.gov/study/NCT00257972
Trial related presentations / publications
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.
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.
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00257972