Phase 4
Completed N=38
Effectiveness of Aripiprazole for Improving Side Effects of Clozapine in the Treatment of People With Schizophrenia
Source: ClinicalTrials.gov NCT00345033 ↗Enrolled (actual)
38
Serious AEs
0.0%
Results posted
Sep 2012
Primary outcomePrimary: Change in Total Cholesterol — -15.3; 5.6 mg/dL — p=0.125
Summary
This study will evaluate the effects of combination treatment with aripiprazole and clozapine on insulin resistance, blood fat levels, and weight gain in people diagnosed with schizophrenia.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Total Cholesterol |
-15.3; 5.6 | 0.125 |
| PRIMARY Change in Weight |
-1.5; 0.3 | 0.109 |
| PRIMARY Change in Body Mass Index (BMI) |
-0.52; 0.03 | 0.229 |
| PRIMARY Change in Glucose Metabolism |
0.003; -0.005 | 0.010 sig |
| PRIMARY Change in Triglycerides |
-5.9; -7.3 | 0.982 |
| PRIMARY Change in Insulin Resistance |
0.6; 0.65 | 0.082 |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of schizophrenia (any subtype) or schizoaffective disorder (any subtype)
- Treatment with clozapine for at least 1 year
- Stable dose of clozapine for at least 1 month
- Well established compliance with outpatient medications
- Female participants of non-childbearing potential or of childbearing potential and willing to practice appropriate birth control methods (complete abstinence from sexual intercourse, female sterilization, sterilization of male partner, implants of levonorgestrel, injectable progestogen, oral contraceptives, intrauterine devices, or double barrier methods of contraception using spermicide with either a condom or diaphragm) during the study
Exclusion Criteria
- Current substance abuse
- Psychiatrically unstable
- Significant medical illness, including severe cardiovascular, hepatic, or renal disease
- History of immunosuppression
- Current or recent radiation or chemotherapy treatment for cancer
- Chronic use of steroids
- Pregnant or breastfeeding
Data sourced from ClinicalTrials.gov (NCT00345033). 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.