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

This study has been terminated.
(Slow Accrual)
Sponsor:
Collaborator:
Otsuka America Pharmaceutical
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00508157
First received: July 26, 2007
Last updated: November 20, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Metabolic Syndrome
Schizophrenia
Drug: Aripiprazole
Drug: Continued Antipsychotic (Risperidone or Quetiapine or Olanzapine)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Mean Percent Change From Baseline in Fasting Non-high Density Lipoprotein (HDL) Cholesterol at Week 16 [ Time Frame: Baseline, Week 16 ] [ Designated as safety issue: Yes ]
    Non-HDL cholesterol was calculated as fasting Total Cholesterol minus fasting HDL Cholesterol.


Secondary Outcome Measures:
  • Number of Participants Remaining on Metabolic Syndrome at Week 16 [ Time Frame: Week 16 ] [ Designated as safety issue: Yes ]
    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.

  • Mean Percent Change From Baseline in Fasting Lipid Parameters Through Week 16 [ Time Frame: Baseline, Week 4, Week 8, Week 12, Week 16 ] [ Designated as safety issue: Yes ]
    Mean percent change from baseline in total cholesterol, low-density lipoprotein (LDL), HDL, and triglycerides.

  • Mean Change From Baseline for Fasting Glucose Levels Through Week 16 [ Time Frame: Baseline, Week 4, Week 8, Week 12, Week 16 ] [ Designated as safety issue: Yes ]
  • Mean Change From Baseline in Body Weight Through Week 16 [ Time Frame: Baseline, Week 4, Week 8, Week 12, Week 16 ] [ Designated as safety issue: Yes ]
  • Median Change From Baseline in Body Mass Index (BMI) Through Week 16 [ Time Frame: Baseline, Week 4, Week 8, Week 12, Week 16 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 125
Study Start Date: November 2007
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00508157

Locations
Belgium
Local Institution
Brussels, Belgium, 1160
Czech Republic
Local Institution
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
France
Local Institution
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
Germany
Local Institution
Ellwangen, Germany, 73479
Local Institution
Werneck, Germany, 97440
Greece
Local Institution
Chania-Crete, Greece, 73300
Local Institution
Corfu, Greece, 49100
Hungary
Local Institution
Budapest, Hungary, 1125
Local Institution
Gyula, Hungary, 5700
Spain
Local Institution
Oviedo, Asturias, Spain, 33011
Local Institution
Barcelona, Spain, 08025
Local Institution
Barcelona, Spain, 08907
Local Institution
Barcelona, Spain, 08036
Switzerland
Local Institution
Wetzikon, Switzerland, 8620
Turkey
Local Institution
Izmir, Turkey, 35370
Sponsors and Collaborators
Bristol-Myers Squibb
Otsuka America Pharmaceutical
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00508157     History of Changes
Other Study ID Numbers: CN138-489, Eudract Number: 2007 001217 42
Study First Received: July 26, 2007
Results First Received: June 22, 2010
Last Updated: November 20, 2013
Health Authority: Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Belgium: Department Research and Development

Additional relevant MeSH terms:
Metabolic Syndrome X
Schizophrenia
Syndrome
Disease
Glucose Metabolism Disorders
Hyperinsulinism
Insulin Resistance
Mental Disorders
Metabolic Diseases
Pathologic Processes
Schizophrenia and Disorders with Psychotic Features
Antipsychotic Agents
Aripiprazole
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 22, 2014