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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Metabolic Syndrome, Schizophrenia

Intervention / Treatment
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* Drug: Aripiprazole
* Drug: Continued Antipsychotic (Risperidone or Quetiapine or Olanzapine)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: Aripiprazole<br>* Tablets, Oral, 5 to 30 mg, once daily, 16 weeks<br>* Other names: BMS-337039;|
| Active Comparator: B<br> | Drug: Continued Antipsychotic (Risperidone or Quetiapine or Olanzapine)<br>* Tablets, Oral, According to summary of product characteristics (SmPC)<br>|

What is the study measuring?
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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 | 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 | 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 | 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 |  | Baseline, Week 4, Week 8, Week 12, Week 16 | 
| Mean Change From Baseline in Body Weight Through Week 16 |  | Baseline, Week 4, Week 8, Week 12, Week 16 | 
| Median Change From Baseline in Body Mass Index (BMI) Through 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 | 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 | 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 | 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 |