Phase 4
Completed N=15
A Placebo-Controlled, Cross-Over Trial of Aripiprazole
Source: ClinicalTrials.gov NCT00351936 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Jan 2013
Primary outcomePrimary: Change From Baseline in Weight (Lbs) — -2.9; 2.1 lbs — p=0.003
Summary
This study is a ten-week, placebo-controlled, double-blind, cross-over, randomized trial of the novel antipsychotic agent, aripiprazole, added to 20 obese stable olanzapine-treated patients with schizophrenia or schizoaffective disorder. The advantage of the crossover design is that each subject will act as their own control and fewer subjects will be required than a between-group design.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Weight (Lbs) |
-2.9; 2.1 | 0.003 sig |
| PRIMARY Change From Baseline in Body Mass Index (BMI) |
-0.4; 0.3 | 0.003 sig |
| PRIMARY Change From Baseline in Waist-hip Ratio (WHR) |
0.0; 0.0 | 0.747 |
| PRIMARY Change From Baseline in Fasting Total Cholesterol |
-3; 9 | 0.208 |
| PRIMARY Change From Baseline in Low-density Lipoprotein (LDL) |
-0.2; 3.1 | 0.665 |
| PRIMARY Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) |
0.4; 0.6 | 0.999 |
| PRIMARY Change From Baseline in Triglycerides |
-51.7; 47.6 | 0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Male or female
- Age 18-65
- Diagnosis of schizophrenia, any subtype, or schizoaffective disorder, any sub-type
- Body mass index > 30 Kg/m2 or >27 Kg/m2 with other risk factors (HTN, Lipid abnormalities)
- Well established compliance with outpatient medications.
- Maintained on a stable dose of olanzapine for at least one month.
Exclusion Criteria
- Serious medical or neurological illness (unstable cardiac disease, malignancy, liver or renal impairment, etc.)
- Current substance abuse
- Psychiatrically unstable, which is defined as a score on the CGI's severity of illness question of 5 or greater or a baseline Total PANSS score > 75
- Pregnancy, nursing, or unwilling to use appropriate birth control measures during participation if female and fertile
- Serious suicidal or homicidal risk within the past three months
Data sourced from ClinicalTrials.gov (NCT00351936). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.