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

NCT ID: NCT00981526

Last Updated: 2018-06-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2012-05-31

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.

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).

Conditions

Schizophrenia; Schizoaffective Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

A: Telmisartan

(existing Clozapine or Olanzapine treatment) + (Telmisartan)

Group Type: EXPERIMENTAL

Telmisartan

Intervention Type: DRUG

Telmisartan 40mg/day for the first 2 weeks.

Telmisartan 80mg/day for the next 10 weeks.

Clozapine

Intervention Type: DRUG

Clozapine (plus telmisartan or placebo) for 12 weeks.

Olanzapine

Intervention Type: DRUG

Olanzapine (plus telmisartan or placebo) for 12 weeks.

B: Placebo

(existing Clozapine or Olanzapine treatment) + (Placebo)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo (plus existing clozapine or olanzapine treatment) for 12 weeks.

Clozapine

Intervention Type: DRUG

Clozapine (plus telmisartan or placebo) for 12 weeks.

Olanzapine

Intervention Type: DRUG

Olanzapine (plus telmisartan or placebo) for 12 weeks.

Interventions

Telmisartan

Telmisartan 40mg/day for the first 2 weeks.

Telmisartan 80mg/day for the next 10 weeks.

Intervention Type: DRUG

Placebo

Placebo (plus existing clozapine or olanzapine treatment) for 12 weeks.

Intervention Type: DRUG

Clozapine

Clozapine (plus telmisartan or placebo) for 12 weeks.

Intervention Type: DRUG

Olanzapine

Olanzapine (plus telmisartan or placebo) for 12 weeks.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

University of Massachusetts, Worcester

OTHER

Sponsor Role: lead

Responsible Party

Xiaoduo Fan

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiaoduo Fan, MD, MPH, MS

Role: PRINCIPAL_INVESTIGATOR

UMass Medical School

Locations

University of Massachusetts Medical School

Worcester, Massachusetts, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 30747254 (View on PubMed)

Fan 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.

Reference Type: DERIVED

PMID: 28851055 (View on PubMed)

Other Identifiers

2008-P-000790

Identifier Type: -

Identifier Source: org_study_id