| Trial ID: | L1947 |
| Source ID: | NCT00231894
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| Associated Drug: |
Pioglitazone
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| Title: |
Pioglitazone as a Treatment for Lipid and Glucose Abnormalities In Patients With Schizophrenia
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| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00231894/results
|
| Conditions: |
Diabetes|Schizophrenia|Insulin Resistance|Cognitive Impairment
|
| Interventions: |
DRUG: Pioglitazone|BEHAVIORAL: Life style diet group|OTHER: Placebo
|
| Outcome Measures: |
Primary: Change From Baseline in Serum Triglycerides at 3 Months ( 3 Months-baseline) US Sample, pre-treatment and during 3 months of treatment|Change From Baseline in Serum HDL at 3 Months (3 Months-baseline) US Sample, serum high density lipoprotein (HDL), pre-treatment and during 3 months of treatment|Change From Baseline in Serum Glucose at 3 Months (3 Months-baseline) US Sample, pretreatment and during 3 months of drug treatment|2 Hour Glucose From Glucose Tolerance Test US Sample, difference between 2 hr glucose for GTT test at baseline vs after 3 months of drug treatment, between baseline and 3 months of study drug treatment | Secondary: Change in RBANS List Recognition Scores at 3 Months (3 Months-baseline) US Sample, The scale is Repeatable Battery for the Assessment to Neuropsychological Status (RBANS). This scale measure cognitive function in patients with schizophrenia. Range for list learning sub-score is 0 to 20 . Higher values indicate better performance. For change score (3 months -baseline) positive values indicate improved performance for this cognitive function and negative values indicate poorer performance on this cognitive function., pre-treatment and 3 months of treatment|Change From Baseline in Serum Glucose at 3 Months ( 3 Months -Baseline) China Sample, pretreatment and during 3 months of drug treatment|Change From Baseline in Serum Triglycerides at 3 Months (3 Months-baseline) China Sample, pretreatment and during 3 months of drug treatment|2 Hour Glucose From Glucose Tolerance Test China Sample, difference between 2 hr glucose for GTT test at baseline vs after 3 months of drug treatment, between baseline and 3 months of study drug treatment|Change From Baseline in Serum HDL at 3 Months (3 Months-baseline) China Site, pretreatment and during 3 months of drug treatment
|
| Sponsor/Collaborators: |
Sponsor: Nathan Kline Institute for Psychiatric Research
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| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
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| Phases: |
PHASE4
|
| Enrollment: |
56
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2005-05
|
| Completion Date: |
2010-01
|
| Results First Posted: |
2017-12-11
|
| Last Update Posted: |
2017-12-11
|
| Locations: |
Nathan Kline Institute for Psychiatric Research, New York, New York, 10035, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00231894
|
