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Intranasal Insulin Treatment in Patients With Schizophrenia

NCT00575666 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2012-12-17

Study results available
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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.

Conditions

Interventions

DRUG

Insulin or Placebo

intranasal, 40IU, 4 times daily

Sponsors & Collaborators

  • National Alliance for Research on Schizophrenia and Depression

    collaborator OTHER

  • Eli Lilly and Company

    collaborator INDUSTRY

  • University of Massachusetts, Worcester

    lead OTHER

Principal Investigators

  • Xiaoduo Fan, MD, MPH, MS · UMass Medical School

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2010-09-30
Completion
2010-09-30

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00575666 on ClinicalTrials.gov