Effect of Single Dose Intranasal Insulin On Cognitive Function

Completed · Phase 4 · Has a placebo group

Conditions studied: Schizophrenia, Schizoaffective Disorder

In brief

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.

Key facts

Study ID

NCT00646581

Run by

University of Massachusetts, Worcester

People needed

30

Starts

2006-10-01

Expected to finish

2010-01-01

Last updated by the study team

2013-02-15

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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.

Where it is running

• Freedom Trail Clinic — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.