CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 66 enrolled
Drug / intervention
Telmisartan +3 moredrug
Likely dose
Telmisartan 40mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00981526
NCT00981526Phase 4Completed

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

University of Massachusetts, Worcester·interventional·Posted Sep 22, 2009·Updated Jun 19, 2018

In Brief

A Phase 4 clinical trial evaluating Telmisartan, Placebo, and 2 other interventions for Schizophrenia and Schizoaffective Disorder. Completed, enrolled 66 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 22, 2009
Enrollment StartMar 1, 2009
Primary CompletionMay 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 16.8 years ago

Interventions

Telmisartandrug

Telmisartan 40mg/day for the first 2 weeks. Telmisartan 80mg/day for the next 10 weeks.

Placebodrug

Placebo (plus existing clozapine or olanzapine treatment) for 12 weeks.

Clozapinedrug

Clozapine (plus telmisartan or placebo) for 12 weeks.

Olanzapinedrug

Olanzapine (plus telmisartan or placebo) for 12 weeks.