Conditions: Schizophrenia Schizoaffective Disorder
Keywords: Schizophrenia Cognition Metabolism Antipsychotics Psychopathology
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 66
Healthy volunteers: no

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).

Arms:
arm 1: (existing Clozapine or Olanzapine treatment) + (Telmisartan) arm 2: (existing Clozapine or Olanzapine treatment) + (Placebo)

Interventions: intervention 1: Telmisartan intervention 2: Placebo intervention 3: Clozapine intervention 4: Olanzapine
Intervention descriptions: intervention 1: Telmisartan 40mg/day for the first 2 weeks.

Telmisartan 80mg/day for the next 10 weeks. intervention 2: Placebo (plus existing clozapine or olanzapine treatment) for 12 weeks. intervention 3: Clozapine (plus telmisartan or placebo) for 12 weeks. intervention 4: Olanzapine (plus telmisartan or placebo) for 12 weeks.

Protocol document: