Telmisartan as an Adjunctive Treatment for Metabolic Problems in Patients With Schizophrenia
Information source: Massachusetts General Hospital
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Schizophrenia; Schizoaffective Disorder
Intervention: Telmisartan (Drug); Placebo (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Massachusetts General Hospital Official(s) and/or principal investigator(s):
Xiaoduo Fan, M.D., Principal Investigator, Affiliation: Massachusetts General Hospital
Overall contact:
Karina Tsatourian, Ph.D., Phone: 617-912-7837, Email: ktsatourian@partners.org
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. A total of 70 subjects will be enrolled.
Clinical Details
Official title: Telmisartan as an Adjunctive Treatment for Metabolic Problems in Patients With Schizophrenia
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment
Primary outcome: Metabolism, weight, food intake, energy, and body composition
Secondary outcome: Cognition and psychopathology
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 the efficacy of telmisartan in improving glucose metabolism as measured by
glucose effectiveness (SG) and the acute insulin response to glucose (AIRG).
3. Examine telmisartan's effects on lipids, body composition, waist circumference, and
waist/hip ratio.
4. Examine telmisartan's effects on weight, food intake and resting energy expenditure.
5. Characterize the relationships between changes in CRP, IL-6, and changes in fasting
insulin and glucose, SI, SG, and AIRG from FSIVGTT.
6. Characterize the relationships between changes in fasting insulin and glucose, SI, SG,
and AIRG from FSIVGTT, CRP, IL-6, and changes in negative symptoms, positive symptoms
and cognitive function.
7. Examine telmisartan's effects on inflammatory biomarkers including C-reactive protein
(CRP) and interleukin 6 (IL-6).
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Age 18-65 years
2. Diagnosis of schizophrenia, any subtype or schizoaffective disorder, any subtype
3. Treatment with clozapine or olanzapine for at least 6 months
4. Stable dose of antipsychotic agent for at least one month
5. Well establish compliance with out-patient medications
6. 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 Criteria:
1. Inability to provide informed consent
2. Current substance abuse
3. Psychiatrically unstable
4. Significant medical illness including severe cardiovascular, hepatic, renal disease
5. Current insulin treatment of diabetes
6. History of immunosuppression
7. Current or recent radiation or chemotherapy treatment for cancer
8. Chronic use of steroids
9. Pregnancy or breast feeding
10. Use of diuretics, digoxin, warfarin because the possible drug-drug interaction of
telmisartan
Locations and Contacts
Karina Tsatourian, Ph.D., Phone: 617-912-7837, Email: ktsatourian@partners.org
Massachusetts General Hospital, Boston, Massachusetts 02116, United States; Recruiting
Xiaduo Fan, M.D., Principal Investigator
Additional Information
Starting date: March 2009
Ending date: December 2010
Last updated: September 21, 2009
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