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

May 21, 2018 updated by: Xiaoduo Fan, University of Massachusetts, Worcester

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 telmisartan's effects on lipids, body composition, and waist/hip ratio.
  3. Examine telmisartan's effects on inflammatory biomarkers including C-reactive protein (CRP) and interleukin 6 (IL-6).

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Worcester, Massachusetts, United States, 01605
        • University of Massachusetts Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

Telmisartan 40mg/day for the first 2 weeks.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insulin Resistance
Time Frame: 12 weeks
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
Time Frame: 12 weeks
Fasting triglycerides assessed in both experimental and placebo arm at week 12.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lipid Metabolism - LDL-cholesterol and HDL-cholesterol
Time Frame: 12 weeks
Lipid metabolism - fasting low density lipoprotein (LDL) and high density lipoprotein (HDL) are estimated in both experimental and placebo arms at 12 weeks.
12 weeks
Psychopathology - PANSS Total, PANSS - Negative Score, PANNS - Positive Score and SANS - Total Scores.
Time Frame: 12 weeks
The Positive and Negative Syndrome Scale (PANSS) and Scale for the Assessment of Negative Symptoms (SANS) were used to assess the positive and negative symptoms in experimental and placebo arms at 12 weeks. The PANSS total scale includes positive and negative subscales. For both subscales, the score ranges from 7-49 and total PANSS score ranges from 30-210. The total scale is a summation of all the subscales. The SANS score ranges from 0-100. For all scales, a greater score represents a worse outcome.
12 weeks
Body Composition: Waist to Hip Ratio
Time Frame: 12 weeks
Body composition as estimated by waist to hip ratio in both experimental and placebo arms at 12 weeks.
12 weeks
Body Composition: Percent Total Body Fat
Time Frame: 12 weeks
Body composition estimated by percent total body fat as measured by a dual energy absorptiometry (DXA) scan in both experimental and placebo arms at 12 weeks.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Massachusetts, Worcester

Collaborators

National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Xiaoduo Fan, MD, MPH, MS, UMass Medical School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

September 18, 2009

First Submitted That Met QC Criteria

September 21, 2009

First Posted (Estimate)

September 22, 2009

Study Record Updates

Last Update Posted (Actual)

June 19, 2018

Last Update Submitted That Met QC Criteria

May 21, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008-P-000790

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Schizophrenia

Clinical Trials on Telmisartan

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ghana

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe