Pioglitazone as a Treatment for Lipid and Glucose Abnormalities In Patients With Schizophrenia

NCT00231894 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2017-12-11

Study results available
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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.

Conditions

Interventions

DRUG

Pioglitazone

pioglitazone 30-45 mg/day

BEHAVIORAL

Life style diet group

life style diet education group 1x/week

OTHER

Placebo

placebo comparator capsules

Sponsors & Collaborators

  • Nathan Kline Institute for Psychiatric Research

    lead OTHER

Principal Investigators

  • Robert C Smith, MD PhD · NYU School of Medicine & Nathan Kline Institute for Psychiatric Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-05-31
Primary Completion
2010-01-31
Completion
2010-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00231894 on ClinicalTrials.gov