Ignite Creation Date:
2025-12-24 @ 4:19 PM
Ignite Modification Date:
2026-02-01 @ 11:22 AM
Study NCT ID:
NCT00575666
Status:
COMPLETED
Last Update Posted:
2012-12-17
First Post:
2007-12-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Intranasal Insulin Treatment in Patients With Schizophrenia
Sponsor:
University of Massachusetts, Worcester
Organization:
Study Overview
Official Title:
Intranasal Insulin Treatment in Patients With Schizophrenia
Status:
COMPLETED
Status Verified Date:
2012-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: