NCT00575666

Intranasal Insulin Treatment in Patients With Schizophrenia

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: University of Massachusetts, Worcester · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	Insulin or Placebo	intranasal, 40IU, 4 times daily

Timeline

• Start date: 2007-12-01
• Primary completion: 2010-09-01
• Completion: 2010-09-01
• First posted: 2007-12-18
• Last updated: 2012-12-17
• Results posted: 2012-12-17

Locations

1 site across 1 country: United States