Conditions: Schizophrenia
Keywords: cognition, psychopathology
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 45
Healthy volunteers: no

Brief summary:
This study is an 8-week, randomized, double-blind, placebo-controlled trial of intranasal insulin as an adjunctive therapy, with a 4-week follow-up, in 60 non-diabetic schizophrenia subjects to examine insulin's effect on psychopathology and cognition. In addition, the study will examine insulin's effects on weight, food intake, resting energy expenditure, and body composition.

Detailed description:
The specific aims include:

Primary aims

1. Examine the efficacy of intranasal regular insulin (40 IU 4 times per day) in improving cognitive deficits in patients with schizophrenia.
2. Examine the efficacy of intranasal regular insulin in improving negative symptoms and positive symptoms of schizophrenia.

Secondary aims

1. Examine intranasal insulin's effects on weight, food intake and resting energy expenditure.
2. Examine intranasal insulin's effects on body composition, waist circumference, and waist/hip ratio.

Arms:
arm 1: Intranasal Insulin Treatment arm 2: Drug: Placebo

Interventions: intervention 1: Insulin or Placebo
Intervention descriptions: intervention 1: intranasal, 40IU, 4 times daily

Protocol document: