Effect of Single Dose Intranasal Insulin On Cognitive Function

NCT ID: NCT00646581

Last Updated: 2013-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2010-01-31

Brief Summary

The purpose of the study is to find out how a small dose of insulin might affect memory, the ability to concentrate, and improve your daily functioning in patients with schizophrenia and schizoaffective disorders. Insulin is not being used to treat diabetes in this study. The investigators propose a single dose, double-blinded, placebo-controlled trial of intranasal insulin in 40 subjects with schizophrenia or schizoaffective disorder to examine insulin's effect on cognition. The specific aims include:

1. Examine the effects of single doses of 40 IU intranasal insulin compared to placebo on cognitive functioning, including attention and memory.

2. Examine whether single dose of intranasal insulin administration will raise serum insulin level and decrease plasma glucose level

Insulin will be delivered through an air spray pump into your nose. The investigators will be comparing one dose of insulin (40 International Units) with placebo, an inactive liquid.

Detailed Description

Insulin signaling in the brain is associated with improved cognitive function in both animal and human studies. Intranasal administration of insulin, which is non-invasive and minimizes the risk of hypoglycemia, may represent a new intervention approach with the potential to improve cognition and real life functioning in this patient with schizophrenia.

Conditions

Schizophrenia; Schizoaffective Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Placebo (1)

Subjects are given a one-time, single dose of placebo intranasal spray

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo

Single-Dose Intranasal Insulin

Subjects are given a one-time, single dose of intranasal insulin

Group Type: EXPERIMENTAL

Insulin (Humulin)

Intervention Type: DRUG

40 IU Intranasal Insulin will be administered once

Interventions

Placebo

Placebo

Intervention Type: DRUG

Insulin (Humulin)

40 IU Intranasal Insulin will be administered once

Intervention Type: DRUG

Other Intervention Names

Humulin

Eligibility Criteria

Inclusion Criteria

• Age 18-65 years
• Diagnosis of schizophrenia, any subtype or schizoaffective disorder, any subtype
• Male or female
• Stable dose of the current antipsychotic drug for at least one month
• Well established compliance with out-patient treatment per treating clinician's judgement.
• Able to complete the cognitive assessment battery (must be English speaking)

Exclusion Criteria

• Inability to provide informed consent
• Current substance abuse
• On clozapine or olanzapine
• Psychiatrically unstable per treating clinician's judgement.
• Significant medical illnesses including uncontrolled hypertension, diabetes, seizure disorder, severe cardiovascular, cerebrovascular, pulmonary, or thyroid diseases etc.
• Incapable to complete the cognitive battery assessment.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Massachusetts, Worcester

OTHER

Sponsor Role: lead

Responsible Party

Xiaoduo Fan

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiaoduo Fan, MD, MPH, MS

Role: PRINCIPAL_INVESTIGATOR

UMass Medical School

Locations

Freedom Trail Clinic

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

CORRC tracking number: 4-2006

Identifier Type: -

Identifier Source: secondary_id

4-2006

Identifier Type: -

Identifier Source: org_study_id