Status:
COMPLETED
Telmisartan as an Adjunctive Treatment for Metabolic Problems in Patients With Schizophrenia
Lead Sponsor:
University of Massachusetts, Worcester
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Schizophrenia
Schizoaffective Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief 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 telmisarta...
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 telmisar...
Eligibility Criteria
Inclusion
- Age 18-65 years
- Diagnosis of schizophrenia, any subtype or schizoaffective disorder, any subtype
- Treatment with clozapine or olanzapine for at least 6 months
- Stable dose of antipsychotic agent for at least one month
- Well establish compliance with out-patient medications
- Females subjects will be eligible to participate in the study if they are of non-childbearing potential or of child-bearing potential and willing to practice appropriate birth control methods (complete abstinence from sexual intercourse, female sterilization, sterilization of male partner, implants of levonorgestrel, injectable progestogen, oral contraceptives, intrauterine devices, or double barrier methods of contraception using spermicide with either a condom or diaphragm) during the study.
Exclusion
- Inability to provide informed consent
- Current substance abuse
- Psychiatrically unstable
- Significant medical illness including severe cardiovascular, hepatic, renal disease
- Current insulin treatment of diabetes
- History of immunosuppression
- Current or recent radiation or chemotherapy treatment for cancer
- Chronic use of steroids
- Pregnancy or breast feeding
- Use of diuretics, digoxin, warfarin because the possible drug-drug interaction of telmisartan
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT00981526
Start Date
March 1 2009
End Date
May 1 2012
Last Update
June 19 2018
Active Locations (1)
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1
University of Massachusetts Medical School
Worcester, Massachusetts, United States, 01605