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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Xiaoduo Fan, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier:
NCT00981526
First received: September 18, 2009
Last updated: August 12, 2013
Last verified: August 2013
  Purpose

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 Intervention Phase
Schizophrenia
Schizoaffective Disorder
Drug: Telmisartan
Drug: Placebo
Drug: Clozapine
Drug: Olanzapine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Telmisartan as an Adjunctive Treatment for Metabolic Problems in Patients With Schizophrenia

Resource links provided by NLM:


Further study details as provided by University of Massachusetts, Worcester:

Primary Outcome Measures:
  • Metabolism, weight, food intake, energy, and body composition [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cognition and psychopathology [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 57
Study Start Date: March 2009
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00981526

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

No publications provided

Responsible Party: Xiaoduo Fan, Principal Investigator, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT00981526     History of Changes
Other Study ID Numbers: 2008-P-000790
Study First Received: September 18, 2009
Last Updated: August 12, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Schizophrenia
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Olanzapine
Clozapine
Telmisartan
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Antihypertensive Agents
Cardiovascular Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Serotonin Antagonists
GABA Antagonists

ClinicalTrials.gov processed this record on September 18, 2014