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This is a 12-week, randomized, double-blinded, placebo-controlled trial of telmisartan 80 mg/day as an adjunctive to clozapine or olanzapine therapy, in 70 schizophrenia subjects to examine telmisartan's effect on glucose metabolism, weight, food intake, resting energy expenditure, and body composition. In addition, the study will examine insulin's effects on psychopathology and cognition.
Potential subjects will be identified by their clinicians at the Freedom Trail Clinic, or Massachusetts General Hospital. A total of 70 subjects will be enrolled.
The specific aims include:
1. Examine the efficacy of telmisartan added to regular doses of clozapine or olanzapine in improving insulin resistance.
2. Examine the efficacy of telmisartan in reducing fasting triglycerides.
1. Examine the effects of telmisartan on negative symptoms, positive symptoms, and cognitive function.
2. Examine the efficacy of telmisartan in improving glucose metabolism as measured by glucose effectiveness (SG) and the acute insulin response to glucose (AIRG).
3. Examine telmisartan's effects on lipids, body composition, waist circumference, and waist/hip ratio.
4. Examine telmisartan's effects on weight, food intake and resting energy expenditure.
5. Characterize the relationships between changes in CRP, IL-6, and changes in fasting insulin and glucose, SI, SG, and AIRG from FSIVGTT.
6. Characterize the relationships between changes in fasting insulin and glucose, SI, SG, and AIRG from FSIVGTT, CRP, IL-6, and changes in negative symptoms, positive symptoms and cognitive function.
7. Examine telmisartan's effects on inflammatory biomarkers including C-reactive protein (CRP) and interleukin 6 (IL-6).
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Massachusetts General Hospital
Massachusetts General Hospital
Published on BioPortfolio: 2014-08-27T03:19:11-0400
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An effect usually, but not necessarily, beneficial that is attributable to an expectation that the regimen will have an effect, i.e., the effect is due to the power of suggestion.
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