drugset / Trial / NCT00981526
Telmisartan as an Adjunctive Treatment for Metabolic Problems in Patients With Schizophrenia
Phase 4
Completed
66 enrolled
University of Massachusetts, Worcester
National Institutes of Health (NIH) · collab
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2009-03
- Primary completion
- 2012-05
- Completion
- 2012-05
Publications
- Fan X, Copeland P, Nawras S, Harrington A, Freudenreich O, Goff DC, Henderson DC. Adjunctive telmisartan treatment on body metabolism in clozapine or olanzapine treated patients with schizophrenia: a randomized, double blind, placebo controlled trial. Psychopharmacology (Berl). 2019 Jun;236(6):1949-1957. doi: 10.1007/s00213-019-5181-z. Epub 2019 Feb 12.
- Fan X, Song X, Zhao M, Jarskog LF, Natarajan R, Shukair N, Freudenreich O, Henderson DC, Goff DC. The effect of adjunctive telmisartan treatment on psychopathology and cognition in patients with schizophrenia. Acta Psychiatr Scand. 2017 Nov;136(5):465-472. doi: 10.1111/acps.12799. Epub 2017 Aug 29.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Telmisartan | Other / unclassified | 80 mg | — |
| Background | Clozapine | Other / unclassified | — | — |
| Background | Olanzapine | Small molecule | — | — |