A Phase 4 Study to Assess the Effects of Aripiprazole Versus Other Atypical Antipsychotics in the Treatment of Schizophrenic Patients With Metabolic Syndrome

November 20, 2013 updated by: Bristol-Myers Squibb

A 16-Week, Multicenter, Randomized, Open-label Study to Assess the Effects of Aripiprazole Versus Other Atypical Antipsychotics in the Treatment of Schizophrenic Patients With Metabolic Syndrome

258 patients who have been treated for at least 3 months with oral olanzapine, risperidone or quetiapine in the treatment of schizophrenia and currently presenting with metabolic syndrome, will be randomized to: i) aripiprazole for 16 weeks, with flexible dosing within a range of 10 to 30 mg once daily (QD); or ii) continue for 16 weeks on the same atypical antipsychotic treatment prior to the study enrollment.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

125

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

  • Belgium
      • Brussels, Belgium, 1160
        • Local Institution
  • Czech Republic
      • Brno, Czech Republic, 625 00
        • Local Institution
      • Brno, Czech Republic, 602 00
        • Local Institution
      • Havirov, Czech Republic, 736 01
        • Local Institution
      • Hradec Kralove, Czech Republic, 500 05
        • Local Institution
      • Prague, Czech Republic, 190 00
        • Local Institution
      • Praha 10, Czech Republic, 100 00
        • Local Institution
      • Praha 6, Czech Republic, 160 00
        • Local Institution
      • Prerov, Czech Republic, 750 02
        • Local Institution
      • Roudnice Nad Labem, Czech Republic, 41301
        • Local Institution
  • France
      • Fains Veel, France, 55000
        • Local Institution
      • Lille Cedex, France, 59037
        • Local Institution
      • Limoges Cedex, France, 87025
        • Local Institution
      • Montpellier, France, 34295
        • Local Institution
      • Paris, France, 75013
        • Local Institution
      • Paris Cedex 14, France, 75674
        • Local Institution
      • Poitiers, France, 86000
        • Local Institution
      • Strasbourg, France, 67000
        • Local Institution
  • Germany
      • Ellwangen, Germany, 73479
        • Local Institution
      • Werneck, Germany, 97440
        • Local Institution
  • Greece
      • Chania-Crete, Greece, 73300
        • Local Institution
      • Corfu, Greece, 49100
        • Local Institution
  • Hungary
      • Budapest, Hungary, 1125
        • Local Institution
      • Gyula, Hungary, 5700
        • Local Institution
  • Spain
      • Barcelona, Spain, 08036
        • Local Institution
      • Barcelona, Spain, 08025
        • Local Institution
      • Barcelona, Spain, 08907
        • Local Institution
    • Asturias
      • Oviedo, Asturias, Spain, 33011
        • Local Institution
  • Switzerland
      • Wetzikon, Switzerland, 8620
        • Local Institution
  • Turkey
      • Izmir, Turkey, 35370
        • 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 being treated with olanzapine, risperidone, or quetiapine for at least 3 months
  • with diagnosis of metabolic syndrome
  • not treated for 1 of the parameters of metabolic syndrome

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: A
Drug: Aripiprazole
Tablets, Oral, 5 to 30 mg, once daily, 16 weeks
Other Names:
  • Abilify
  • BMS-337039
ACTIVE_COMPARATOR: B
Drug: Continued Antipsychotic (Risperidone or Quetiapine or Olanzapine)
Tablets, Oral, According to summary of product characteristics (SmPC)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Percent Change From Baseline in Fasting Non-high Density Lipoprotein (HDL) Cholesterol at Week 16
Time Frame: Baseline, Week 16
Non-HDL cholesterol was calculated as fasting Total Cholesterol minus fasting HDL Cholesterol.
Baseline, Week 16

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Remaining on Metabolic Syndrome at Week 16
Time Frame: Week 16
Metabolic syndrome is defined as the presence of at least 3 out of the following Adult Treatment Panel III-A (ATP III-A) criteria (all of which are to be assessed at the same visit): waist >102 cm in males, >88 cm in females; blood pressure (BP) systolic BP ≥130 or diastolic BP ≥85 mm Hg; fasting HDL <40 mg/dL in males, <50 mg/dL in females; fasting triglycerides ≥150 mg/dL; fasting glucose ≥100 mg/dL, and/or the start of a treatment for any of the parameters of metabolic syndrome during the course of the study.
Week 16
Mean Percent Change From Baseline in Fasting Lipid Parameters Through Week 16
Time Frame: Baseline, Week 4, Week 8, Week 12, Week 16
Mean percent change from baseline in total cholesterol, low-density lipoprotein (LDL), HDL, and triglycerides.
Baseline, Week 4, Week 8, Week 12, Week 16
Mean Change From Baseline for Fasting Glucose Levels Through Week 16
Time Frame: Baseline, Week 4, Week 8, Week 12, Week 16
Baseline, Week 4, Week 8, Week 12, Week 16
Mean Change From Baseline in Body Weight Through Week 16
Time Frame: Baseline, Week 4, Week 8, Week 12, Week 16
Baseline, Week 4, Week 8, Week 12, Week 16
Median Change From Baseline in Body Mass Index (BMI) Through Week 16
Time Frame: Baseline, Week 4, Week 8, Week 12, Week 16
Baseline, Week 4, Week 8, Week 12, Week 16
Mean Change From Baseline in Clinical Global Impression-Severity (CGI-S) Scale Through Week 16
Time Frame: Baseline, Week 4, Week 8, Week 12, Week 16
A CGI-S assessment (a 7-point scale to evaluate the severity of symptoms) was performed at baseline (1=normal; 7=among the most extremely ill patients). A decrease in value indicates improvement.
Baseline, Week 4, Week 8, Week 12, Week 16
Mean Change From Baseline in Subjective Well-Being Under Neuroleptics Scale (SWN-short Form) Through Week 16
Time Frame: Baseline, Week 4, Week 8,Week 12, Week 16
The SWN-short form is a 20-item self-report instrument that measures subjective well-being under neuroleptics. 10 positive and 10 negative items cover 5 health domains (subscales) (4 items each): emotional regulation, self-control, mental functioning, social integration, and physical functioning. Individual scores range from 1 (not at all) to 6 (very much). With negative item scores being reversed, Subscale scores range from 4 to 24 and Total score ranges from 20 to 120.
Baseline, Week 4, Week 8,Week 12, Week 16
Mean Change From Baseline in the Impact of Weight on Quality of Life (IWQoL-Lite) Scale Through Week 16
Time Frame: Baseline, Week 4, Week 8, Week 12, Week 16
IWQoL-Lite is a 31-item self-report inventory to assess the impact of weight on quality of life among patients with obesity. Subscales include: Physical Function, Self Esteem, Sexual Life, Public Distress and Work. The rescaled IWQoL-Lite Total Score is determined by the sum of the 1 to 5 scores on all 31 items and rescaling this sum to a 0-100 scoring with 0=the poorest and 100=the best quality of life. A change of 7.8 to 12.0 points on the rescaled IWQoL-Lite Total Score=a meaningful improvement. A change of -4.5 to -7.6 on the rescaled IWQoL-Lite Total Score=a meaningful deterioration.
Baseline, Week 4, Week 8, Week 12, Week 16

Collaborators and Investigators

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

Sponsor

Bristol-Myers Squibb

Collaborators

Otsuka America Pharmaceutical

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

November 1, 2007

Primary Completion (ACTUAL)

March 1, 2009

Study Completion (ACTUAL)

March 1, 2009

Study Registration Dates

First Submitted

July 26, 2007

First Submitted That Met QC Criteria

July 26, 2007

First Posted (ESTIMATE)

July 27, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

December 13, 2013

Last Update Submitted That Met QC Criteria

November 20, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CN138-489
  • Eudract Number: 2007 001217 42

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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