Effect on Cognitive Function of a Treatment With Aripiprazole

This study has been completed.
Sponsor:
Collaborator:
Otsuka America Pharmaceutical
Information provided by:
Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier:
NCT00329810
First received: September 12, 2005
Last updated: November 7, 2013
Last verified: February 2012
  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:


Further study details as provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00329810

Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
Otsuka America Pharmaceutical
Investigators
Principal Investigator: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided by Otsuka Pharmaceutical Development & Commercialization, Inc.

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: November 7, 2013
Health Authority: Belgium: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 23, 2014