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
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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