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

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ClinicalTrials.gov Identifier: NCT00981526
Recruitment Status : Completed
First Posted : September 22, 2009
Last Update Posted : August 21, 2013
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment Phase
Schizophrenia Schizoaffective Disorder Drug: Telmisartan Drug: Placebo Drug: Clozapine Drug: Olanzapine Phase 4

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).

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Telmisartan as an Adjunctive Treatment for Metabolic Problems in Patients With Schizophrenia
Study Start Date : March 2009
Primary Completion Date : May 2012
Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: A: Experimental
(existing Clozapine or Olanzapine treatment) + (Drug)
Drug: Telmisartan

Telmisartan (plus existing clozapine or olanzapine treatment) 40mg/day for the first 2 weeks.

Telmisartan (plus existing clozapine or olanzapine treatment) 80mg/day for the next 10 weeks.

Drug: Clozapine
Clozapine (plus telmisartan or placebo) for 12 weeks.
Drug: Olanzapine
Olanzapine (plus telmisartan or placebo) for 12 weeks.
Placebo Comparator: B: Placebo
(existing Clozapine or Olanzapine treatment) + (Placebo)
Drug: Placebo
Placebo (plus existing clozapine or olanzapine treatment) for 12 weeks.
Drug: Clozapine
Clozapine (plus telmisartan or placebo) for 12 weeks.
Drug: Olanzapine
Olanzapine (plus telmisartan or placebo) for 12 weeks.


Outcome Measures

Primary Outcome Measures :
  1. Metabolism, weight, food intake, energy, and body composition [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Cognition and psychopathology [ Time Frame: 12 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00981526


Locations
United States, Massachusetts
University of Massachusetts Medical School
Worcester, Massachusetts, United States, 01605
Sponsors and Collaborators
University of Massachusetts, Worcester
National Institutes of Health (NIH)
Investigators
Principal Investigator: Xiaoduo Fan, MD, MPH, MS UMass Medical School
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Xiaoduo Fan, Principal Investigator, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT00981526     History of Changes
Other Study ID Numbers: 2008-P-000790
First Posted: September 22, 2009    Key Record Dates
Last Update Posted: August 21, 2013
Last Verified: August 2013

Keywords provided by Xiaoduo Fan, University of Massachusetts, Worcester:
Schizophrenia
Cognition
Metabolism
Antipsychotics
Psychopathology

Additional relevant MeSH terms:
Schizophrenia
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Olanzapine
Clozapine
Telmisartan
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Serotonin Antagonists
GABA Antagonists
GABA Agents