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Awarded Trial: 04T-584

Grant ID

04T-584

Illness

Schizophrenia with Metabolic Abnormalities

Primary Drug/Intervention

Pioglitazone

Primary Dosage

30 mg

Secondary Drug Intervention

N/A

Secondary Dosage

N/A

Other Drug/Intervention

N/A

Other Dosage

N/A

Status

Completed

Investigator

Smith

Sample Size

40

Duration of Study Period for Each Subject

12 weeks

Outcome Measurements

Body mass index and related measures; glucose, lipids and related measures; PANSS, CGI, cognitive battery

Results

Fifty-four (54) patients with schizophrenia were randomized to adjunct pioglitazone or placebo for 12 weeks. The study was done at five sites in the U.S. and one in China. Patients on pioglitazone showed a significant improvement on the PANSS total score as well as improvement in some metabolic indicators, as expected. Pioglitzaone had no effect on cognition. Analysis of the data was complicated by the fact that results in the Chinese population differed somewhat that at the five U.S. sites.

Publication

Smith RC, Jin H, Li C, Bark N, Shekhar A, Dwivedi S, et al. Effects of Pioglitazone on Metabolic Abnormalities, Psychopathology, and Cognitive Function in Schizophrenic Patients Treated with Antipsychotic Medication: A Randomized Double-Blind Study. Shizophr Res 2013;143:18-24.

Link

N/A

PI Name

Robert Smith

Degree

MD

Center

Department of Psychiatry

Institution

NYU Medical School

Address

P.O. Box 316

City or Town

Hewlett

State or Province

NY

Zip or Postal Code

11557

Country

USA

Email Address

robert.smith@med.nyu.edu