NCT00981526

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: University of Massachusetts, Worcester · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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. Approximately 70 subjects will be enrolled.

Detailed 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 telmisartan's effects on lipids, body composition, and waist/hip ratio. 3. Examine telmisartan's effects on inflammatory biomarkers including C-reactive protein (CRP) and interleukin 6 (IL-6).

Conditions

• Schizophrenia
• Schizoaffective Disorder

Interventions

Type	Name	Description
DRUG	Telmisartan	Telmisartan 40mg/day for the first 2 weeks. Telmisartan 80mg/day for the next 10 weeks.
DRUG	Placebo	Placebo (plus existing clozapine or olanzapine treatment) for 12 weeks.
DRUG	Clozapine	Clozapine (plus telmisartan or placebo) for 12 weeks.
DRUG	Olanzapine	Olanzapine (plus telmisartan or placebo) for 12 weeks.

Timeline

• Start date: 2009-03-01
• Primary completion: 2012-05-01
• Completion: 2012-05-01
• First posted: 2009-09-22
• Last updated: 2018-06-19
• Results posted: 2018-06-19

Locations

1 site across 1 country: United States