A Phase 4 Study to Assess the Effects of Aripiprazole Versus Other Atypical Antipsychotics in the Treatment of Schizophrenic Patients With Metabolic Syndrome
- Conditions
- SchizophreniaMetabolic Syndrome
- Interventions
- Drug: Continued Antipsychotic (Risperidone or Quetiapine or Olanzapine)
- Registration Number
- NCT00508157
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 125
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
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description B Continued Antipsychotic (Risperidone or Quetiapine or Olanzapine) - A Aripiprazole -
- Primary Outcome Measures
Name Time Method Mean Percent Change From Baseline in Fasting Non-high Density Lipoprotein (HDL) Cholesterol at Week 16 Baseline, Week 16 Non-HDL cholesterol was calculated as fasting Total Cholesterol minus fasting HDL Cholesterol.
- Secondary Outcome Measures
Name Time Method Number of Participants Remaining on Metabolic Syndrome at Week 16 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.
Mean Percent Change From Baseline in Fasting Lipid Parameters Through Week 16 Baseline, Week 4, Week 8, Week 12, Week 16 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 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 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.
Mean Change From Baseline in Subjective Well-Being Under Neuroleptics Scale (SWN-short Form) Through Week 16 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.
Mean Change From Baseline in the Impact of Weight on Quality of Life (IWQoL-Lite) Scale Through Week 16 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.
Trial Locations
- Locations (1)
Local Institution
🇹🇷Izmir, Turkey