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Telmisartan as an Adjunctive Treatment for Metabolic Problems in Patients With Schizophrenia

2014-08-27 03:19:11 | BioPortfolio

Summary

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.

Description

The specific aims include:

Primary Aims:

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.

Secondary Aims:

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).

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Schizophrenia

Intervention

Telmisartan, Placebo

Location

Massachusetts General Hospital
Boston
Massachusetts
United States
02116

Status

Recruiting

Source

Massachusetts General Hospital

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:19:11-0400

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A chronic form of schizophrenia characterized primarily by the presence of persecutory or grandiose delusions, often associated with hallucination.

A type of schizophrenia characterized by abnormality of motor behavior which may involve particular forms of stupor, rigidity, excitement or inappropriate posture.

An obsolete concept, historically used for childhood mental disorders thought to be a form of schizophrenia.

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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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