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

NCT00981526 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2018-06-19

Study results available
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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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • University of Massachusetts, Worcester

    lead OTHER

Principal Investigators

  • Xiaoduo Fan, MD, MPH, MS · UMass Medical School

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2012-05-31
Completion
2012-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00981526 on ClinicalTrials.gov