Telmisartan as an Adjunctive Treatment for Metabolic Problems in Patients With Schizophrenia
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Intervention: Telmisartan; Placebo; Clozapine; Olanzapine
Intervention description: Telmisartan 40mg/day for the first 2 weeks.
Telmisartan 80mg/day for the next 10 weeks.; Placebo (plus existing clozapine or olanzapine treatment) for 12 weeks.; Clozapine (plus telmisartan or placebo) for 12 weeks.; Olanzapine (plus telmisartan or placebo) for 12 weeks.
Intervention MeSH terms: Telmisartan; Olanzapine; Clozapine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 66.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Schizophrenia; Cognition; Metabolism; Antipsychotics; Psychopathology

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.
    

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