A Study of Adjunctive Treatment of Aripiprazole in Schizophrenic Patients

November 7, 2013 updated by: Otsuka Pharmaceutical Development & Commercialization, Inc.

A Multicenter, Comparative, Randomized, Double-Blind, Placebo Controlled Study on the Effect on Weight of Adjunctive Treatment With Aripiprazole in Patients With Schizophrenia.

The purpose of this study is to evaluate the effect on patient weight of adjunctive therapy of aripiprazole with clozapine versus clozapine monotherapy, in schizophrenic patients who are not optimally controlled on clozapine.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria
        • Local Institution
      • Innsbruck, Austria
        • Local Institution
      • Wien, Austria
        • Local Institution
  • Czech Republic
      • Brno - Bohunice, Czech Republic
        • Local Institution
      • Hradec Kralove, Czech Republic
        • Local Institution
      • Litomerice, Czech Republic
        • Local Institution
      • Opava, Czech Republic
        • Local Institution
      • Praha, Czech Republic
        • Local Institution
  • Finland
      • Helsingin Kaupunki, Finland
        • Local Institution
      • Tampere, Finland
        • Local Institution
      • Turku, Finland
        • Local Institution
  • France
      • Brumath Cedex, France
        • Local Institution
      • Bully Les Mines, France
        • Local Institution
      • Clermont-Ferrand Cedex, France
        • Local Institution
      • Limoges Cedex, France
        • Local Institution
      • Lyon Cedex 08, France
        • Local Institution
      • Nimes, France
        • Local Institution
      • Paris Cedex 14, France
        • Local Institution
      • Rennex Cedex 7, France
        • Local Institution
      • Sotteville Les Rouen, France
        • Local Institution
  • Germany
      • Augsburg, Germany
        • Local Institution
      • Berlin, Germany
        • Local Institution
      • Duisburg, Germany
        • Local Institution
      • Haar, Germany
        • Local Institution
      • Heidelberg, Germany
        • Local Institution
      • Mannheim, Germany
        • Local Institution
  • Hungary
      • Budapest, Hungary
        • Local Institution
      • Szolnok, Hungary
        • Local Institution
  • Poland
      • Krakow, Poland
        • Local Institution
      • Leszno, Poland
        • Local Institution
      • Skorzewo, Poland
        • Local Institution
      • Torun, Poland
        • Local Institution
      • Warszawa, Poland
        • Local Institution
  • South Africa
    • Gauteng
      • Soweto, Gauteng, South Africa
        • Local Institution
      • Vereeniging, Gauteng, South Africa
        • Local Institution
    • Kwa Zulu Natal
      • Durban, Kwa Zulu Natal, South Africa
        • Local Institution
    • Western Cape
      • Bellville, Western Cape, South Africa
        • Local Institution
      • Cape Town, Western Cape, South Africa
        • Local Institution
  • Sweden
      • Bromma, Sweden
        • Local Institution
      • Falkoping, Sweden
        • Local Institution
      • Linkoping, Sweden
        • Local Institution
      • Lulea, Sweden
        • Local Institution
      • Malmo, Sweden
        • Local Institution
      • Solna, Sweden
        • Local Institution
      • Uppsala, Sweden
        • Local Institution
      • Varberg, Sweden
        • Local Institution
      • Vastra Frolunda, Sweden
        • Local Institution
  • Switzerland
      • Bern 60, Switzerland
        • Local Institution
  • Turkey
      • Antalya, Turkey
        • Local Institution
      • Istanbul, Turkey
        • Local Institution
      • Izmir, Turkey
        • Local Institution
  • United Kingdom
      • London, United Kingdom
        • Local Institution
    • Devon
      • Exeter, Devon, United Kingdom
        • Local Institution
      • Teignmouth, Devon, United Kingdom
        • Local Institution
    • Hertfordshire
      • Welwyn Garden City, Hertfordshire, United Kingdom
        • Local Institution
    • North Yorkshire
      • Hull, North Yorkshire, United Kingdom
        • Local Institution
    • Tayside
      • Dundee, Tayside, United Kingdom
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with schizophrenia treated with clozapine (200-900 mg/day), who gained at least 2.5 kg while on clozapine.

Exclusion Criteria:

  • Patients known to be allergic to aripiprazole
  • Hospitalized patients
  • Patients who have previously received study medication in an aripiprazole clinical study or who have participated in any clinical trial with an investigational agent within the past month.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A1
Drug: aripiprazole
Tablets, Oral, 5 mg, 10 mg, 15 mg, once daily, 16 weeks followed by 12 weeks of Open-Label extension phase (optional).
Other Names:
  • Abilify
Placebo Comparator: A2
Drug: Placebo
Tablets, Oral, 0 mg, once daily, 16 weeks followed by 12 weeks of Open-Label extension phase (optional)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Evaluate effect on patient weight of adjunctive therapy of aripiprazole with clozapine versus clozapine mono-therapy in schizophrenic patients who are not optimally controlled on clozapine.
The mean change from baseline in patient weight at Week 16 (LOCF) will be compared between the 2 groups.

Secondary Outcome Measures

Outcome Measure
Safety
Efficacy (PANSS, CGI)
Effectiveness (IAQ, GAF)
Patient Reported Outcomes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Collaborators

Otsuka America Pharmaceutical

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2005

Primary Completion (Actual)

July 1, 2007

Study Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

March 8, 2006

First Submitted That Met QC Criteria

March 8, 2006

First Posted (Estimate)

March 10, 2006

Study Record Updates

Last Update Posted (Estimate)

November 8, 2013

Last Update Submitted That Met QC Criteria

November 7, 2013

Last Verified

June 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CN138-170

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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