Telmisartan as an Adjunctive Treatment for Metabolic Problems in Patients With Schizophrenia
1 other identifier
interventional
66
1 country
1
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 schizophrenia
Started Mar 2009
Typical duration for phase_4 schizophrenia
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
September 18, 2009
CompletedFirst Posted
Study publicly available on registry
September 22, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedResults Posted
Study results publicly available
June 19, 2018
CompletedJune 19, 2018
May 1, 2018
3.2 years
September 18, 2009
October 20, 2016
May 21, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Insulin Resistance
Insulin resistance as estimated by homeostasis model of assessment of insulin resistance (HOMA-IR) at week 12 in both the experimental and placebo arm. Insulin resistance is a condition in which cells fail to respond to the normal action of the hormone in the body. The HOMA-IR is calculated using a subject's fasting plasma insulin and glucose levels. The higher the score, the higher the level of insulin resistance.
12 weeks
Triglycerides
Fasting triglycerides assessed in both experimental and placebo arm at week 12.
12 weeks
Secondary Outcomes (4)
Lipid Metabolism - LDL-cholesterol and HDL-cholesterol
12 weeks
Psychopathology - PANSS Total, PANSS - Negative Score, PANNS - Positive Score and SANS - Total Scores.
12 weeks
Body Composition: Waist to Hip Ratio
12 weeks
Body Composition: Percent Total Body Fat
12 weeks
Study Arms (2)
A: Telmisartan
EXPERIMENTAL(existing Clozapine or Olanzapine treatment) + (Telmisartan)
B: Placebo
PLACEBO COMPARATOR(existing Clozapine or Olanzapine treatment) + (Placebo)
Interventions
Telmisartan 40mg/day for the first 2 weeks. Telmisartan 80mg/day for the next 10 weeks.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Massachusetts Medical School
Worcester, Massachusetts, 01605, United States
Related Publications (2)
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.
PMID: 30747254DERIVEDFan 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.
PMID: 28851055DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Xiaoduo Fan
- Organization
- UMass Medical School
Study Officials
- PRINCIPAL INVESTIGATOR
Xiaoduo Fan, MD, MPH, MS
UMass Medical School
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 18, 2009
First Posted
September 22, 2009
Study Start
March 1, 2009
Primary Completion
May 1, 2012
Study Completion
May 1, 2012
Last Updated
June 19, 2018
Results First Posted
June 19, 2018
Record last verified: 2018-05