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Effect on Cognitive Function of a Treatment With Aripiprazole

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Aripiprazole
Sponsored by
Otsuka Pharmaceutical Development & Commercialization, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    September 12, 2005
    Last Updated
    November 7, 2013
    Sponsor
    Otsuka Pharmaceutical Development & Commercialization, Inc.
    Collaborators
    Otsuka America Pharmaceutical
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    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

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    Effect on Cognitive Function of a Treatment With Aripiprazole

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