Phase 4
Completed N=77
Ziprasidone for Improving Insulin Sensitivity in People With Schizophrenia Who Are at Risk for Diabetes
Schizophrenia · Metabolic Syndrome X · Insulin Resistance
Source: ClinicalTrials.gov NCT00338949 ↗
Enrolled (actual)
77
Serious AEs
5.5%
Results posted
Aug 2020
Primary outcomePrimary: Change in Insulin Sensitivity Index From Baseline to Week 26 ((1/mU/L) x 1/Min) — 0.072; 0.407 (1/mU/L) x 1/Min — p=0.228
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This study will evaluate the effectiveness of ziprasidone treatment versus treatment with a standard atypical antipsychotic drug in improving insulin sensitivity and reducing excess abdominal fat storage in people with schizophrenia who are at risk for diabetes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Insulin Sensitivity Index From Baseline to Week 26 ((1/mU/L) x 1/Min) |
0.072; 0.407 | 0.228 |
| PRIMARY Change in Visceral Fat Mass From Baseline to Week 26 |
315; 392 | 0.958 |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of schizophrenia or schizoaffective disorder
- Currently receiving antipsychotic therapy with risperidone or olanzapine
- Overweight
Exclusion Criteria
- Diagnosis of diabetes
- Hospitalization for schizophrenia or schizoaffective disorder within 90 days prior to study entry
- Refractory schizophrenia or schizoaffective disorder
- Currently receiving therapy with clozapine
- No stable residence and phone number for 90 days prior to study entry
- Prior unsuccessful treatment with ziprasidone
- Intolerance to ziprasidone
Data sourced from ClinicalTrials.gov (NCT00338949). 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.