Back to resultsEffect on Cognitive Function of a Treatment With Aripiprazole
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Aripiprazole
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia
Eligibility Criteria
Inclusion Criteria: Diagnosis of Schizophrenia score of 2-6 in the CGI-S scale at basline ambulatory or hospitalized subjects having symptoms which requires antipsychotic treatment Exclusion Criteria: women of child bearing potential women pregnant or breast feeding patients with a score of 0,-1 or 7 substance use
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Switch
Arm Description
Outcomes
Primary Outcome Measures
Clinical Global Impression scale at endpoint
Secondary Outcome Measures
Change in Clinical Global Impression scale and cognition scales at endpoint
Full Information
NCT ID
NCT00329810
First Posted
September 12, 2005
Last Updated
November 7, 2013
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborators
Otsuka America Pharmaceutical
1. Study Identification
Unique Protocol Identification Number
NCT00329810
Brief Title
Effect on Cognitive Function of a Treatment With Aripiprazole
Official Title
A Prospective, Multicenter, Open-Label Study to Evaluate the Effectiveness and the Effect on Cognitive Function of a Treatment With Aripiprazole in a Board Range of Schizophrenic Patients
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
March 2006 (Actual)
Study Completion Date
March 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborators
Otsuka America Pharmaceutical
4. Oversight
5. Study Description
Brief Summary
To evaluate the effectiveness of Aripiprazole after 12 weeks of therapy for Schizophrenic patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
500 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Switch
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Aripiprazole
Other Intervention Name(s)
Abilify
Intervention Description
Tablets, oral, 15 mg, once daily, 12 weeks.
Primary Outcome Measure Information:
Title
Clinical Global Impression scale at endpoint
Secondary Outcome Measure Information:
Title
Change in Clinical Global Impression scale and cognition scales at endpoint
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of Schizophrenia
score of 2-6 in the CGI-S scale at basline
ambulatory or hospitalized subjects having symptoms which requires antipsychotic treatment
Exclusion Criteria:
women of child bearing potential
women pregnant or breast feeding
patients with a score of 0,-1 or 7
substance use
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
23018547
Citation
Bervoets C, Morrens M, Vansteelandt K, Kok F, de Patoul A, Halkin V, Pitsi D, Constant E, Peuskens J, Sabbe B. Effect of aripiprazole on verbal memory and fluency in schizophrenic patients : results from the ESCAPE study. CNS Drugs. 2012 Nov;26(11):975-82. doi: 10.1007/s40263-012-0003-4. Erratum In: CNS Drugs. 2012 Nov;26(11):1011-2.
Results Reference
derived
Learn more about this trial
Effect on Cognitive Function of a Treatment With Aripiprazole
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