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Effect on Cognitive Function of a Treatment With Aripiprazole

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ClinicalTrials.gov Identifier: NCT00329810
Recruitment Status : Completed
First Posted : May 25, 2006
Last Update Posted : November 8, 2013
Sponsor:
Collaborator:
Otsuka America Pharmaceutical
Information provided by:
Otsuka Pharmaceutical Development & Commercialization, Inc.

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

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Aripiprazole Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 500 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : March 2005
Actual Primary Completion Date : March 2006
Actual Study Completion Date : March 2006

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Switch Drug: Aripiprazole
Tablets, oral, 15 mg, once daily, 12 weeks.
Other Name: Abilify




Primary Outcome Measures :
  1. Clinical Global Impression scale at endpoint

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00329810


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

Additional Information:
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
First Posted: May 25, 2006    Key Record Dates
Last Update Posted: November 8, 2013
Last Verified: February 2012

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Aripiprazole
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs