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Effect on Cognitive Function of a Treatment With Aripiprazole

This study has been completed.
Sponsor:
Collaborator:
Otsuka America Pharmaceutical
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00329810
First received: September 12, 2005
Last updated: February 16, 2012
Last verified: February 2012
History of Changes
  Purpose

To evaluate the effectiveness of Aripiprazole after 12 weeks of therapy for Schizophrenic patients.


Condition Intervention Phase
Schizophrenia
 Drug: Aripiprazole
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Clinical Global Impression scale at endpoint

Secondary Outcome Measures:
  • Change in Clinical Global Impression scale and cognition scales at endpoint

Enrollment: 500
Study Start Date: March 2005
Study Completion Date: March 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Switch Drug: Aripiprazole
Tablets, oral, 15 mg, once daily, 12 weeks.
Other Name: Abilify

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00329810

Sponsors and Collaborators
Bristol-Myers Squibb
Otsuka America Pharmaceutical
Investigators
Principal Investigator: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

No publications provided by Bristol-Myers Squibb

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00329810     History of Changes
Other Study ID Numbers: CN138-166
Study First Received: September 12, 2005
Last Updated: February 16, 2012
Health Authority: Belgium: Institutional Review Board

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Aripiprazole
Antipsychotic Agents
Tranquilizing Agents
 Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on May 19, 2013