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

September 12, 2005
November 7, 2013
March 2005
March 2006   (final data collection date for primary outcome measure)
Clinical Global Impression scale at endpoint
Same as current
Complete list of historical versions of study NCT00329810 on ClinicalTrials.gov Archive Site
Change in Clinical Global Impression scale and cognition scales at endpoint
Same as current
Not Provided
Not Provided
 
Effect on Cognitive Function of a Treatment With Aripiprazole
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

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

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Schizophrenia
Drug: Aripiprazole
Tablets, oral, 15 mg, once daily, 12 weeks.
Other Name: Abilify
Experimental: Switch
Intervention: Drug: Aripiprazole
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
500
March 2006
March 2006   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00329810
CN138-166
Not Provided
Not Provided
Otsuka Pharmaceutical Development & Commercialization, Inc.
Otsuka America Pharmaceutical
Principal Investigator: Bristol-Myers Squibb Bristol-Myers Squibb
Otsuka Pharmaceutical Development & Commercialization, Inc.
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP