Phase 4
Completed N=56
Pioglitazone as a Treatment for Lipid and Glucose Abnormalities In Patients With Schizophrenia
Source: ClinicalTrials.gov NCT00231894 ↗Enrolled (actual)
56
Serious AEs
0.0%
Results posted
Dec 2017
Primary outcomePrimary: Change From Baseline in Serum Triglycerides at 3 Months ( 3 Months-baseline) US Sample — -49.65; 30.99 mg/dL
◆ Published Evidence
Established
53citations · ~4 / year
Effects of pioglitazone on metabolic abnormalities, psychopathology, and cognitive function in schizophrenic patients treated with antipsychotic medication: a randomized double-blind study.
Summary
This is a study with an approved drug for treating type 2 diabetes, for its effects on treating glucose and lipid abnormalities in patients being treated with first or second-generation antipsychotics, and comparison of effects of this drug with another treatment lifestyle modification. Patients who meet inclusion criteria will be treated with pioglitazone for 12 weeks. They will be evaluated for fasting glucose and lipids, glucose-tolerance tests, and neurocognitive battery and tests of verbal memory at baseline and during treatment with pioglitazone.
Linked Publications
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Effects of pioglitazone on metabolic abnormalities, psychopathology, and cognitive function in schizophrenic patients treated with antipsychotic medication: a randomized double-blind study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Serum Triglycerides at 3 Months ( 3 Months-baseline) US Sample |
-49.65; 30.99 | — |
| PRIMARY Change From Baseline in Serum HDL at 3 Months (3 Months-baseline) US Sample |
4.62; -2.59 | — |
| PRIMARY Change From Baseline in Serum Glucose at 3 Months (3 Months-baseline) US Sample |
0.02; 24.20 | — |
| PRIMARY 2 Hour Glucose From Glucose Tolerance Test US Sample |
-24.19; 15.19 | — |
| SECONDARY Change in RBANS List Recognition Scores at 3 Months (3 Months-baseline) US Sample |
0.27; -1.11 | — |
| SECONDARY Change From Baseline in Serum Glucose at 3 Months ( 3 Months -Baseline) China Sample |
-13.33; -11.5 | — |
| SECONDARY Change From Baseline in Serum Triglycerides at 3 Months (3 Months-baseline) China Sample |
32.56; -79.12 | — |
| SECONDARY 2 Hour Glucose From Glucose Tolerance Test China Sample |
-6.82; -40.72 | — |
| SECONDARY Change From Baseline in Serum HDL at 3 Months (3 Months-baseline) China Site |
6.52; 7.72 | — |
Eligibility Criteria
Inclusion Criteria
- Patients will be males or females, 18-70 yrs of age, with a diagnosis of schizophrenia or schizoaffective disorder, and currently being treated with olanzapine or clozapine.
- Patients will have evidence of:
- glucose levels indicating at least impaired fasting glucose: fasting glucose 100 mg/dL or 2 hr glucose tolerance test 140 mg/dL, or current treatment with oral antidiabetic drugs with history of hyperglycemia;
- Triglyceride levels > 120 mg/dL and/or HDL levels 200 mg/dL plus 2 hr glucose on GTT >200 mg/dL; (these patients may need more immediate treatment with antidiabetic drugs and it is less certain if weight-lifestyle treatment would be effective in treating such high glucose levels);
- Patients with active liver disease with clinical abnormalities which need current treatment, or liver enzymes (Alt) 3 times upper limit for normal values in chart records in last year, or patients who are recorded as positive for hepatitis C;
- Congestive heart failure (Class III or IV cardiac status) or history of MI in medical record (because pioglitazone can increase blood volume slightly);
- Hematocrit greater than 10% below normal (hematocrit may be decreased 2 to 4% due to increased plasma volume);
- Female patients on current oral contraceptives (because pioglitazone may interfere with effects of some oral contraceptives);
- Patients taking ketoconazole,
- Patients who have started on atorvastatin or gemfibrozil in the past 2 months or have had a dose increase in atorvastatin in the last month (since these drugs can also lower triglycerides and raise HDL, recent start of therapy with these drugs could be a confound).
- Patients are not concomitantly treated with aripiprazole or ziprasidone.
Data sourced from ClinicalTrials.gov (NCT00231894) and the linked publication. 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.