Phase 4 Completed N=30 Randomized Triple-blind Treatment

Effect of Single Dose Intranasal Insulin On Cognitive Function

Schizophrenia · schizoaffective disorder

Source: ClinicalTrials.gov NCT00646581 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2013

Primary outcomePrimary: Improvement in Cognitive Function- HVLT Immediate Recall Total (Number) — 4.9; 5.3 Words successfully recalled

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Improvement in Cognitive Function- HVLT Immediate Recall Total (Number)	4.9; 5.3	—
PRIMARY Improvement in Cognitive Function- HVLT-Delayed Recall (Number)	1.1; 1.4	—
PRIMARY CPT d Score	0.12; 0.29	—
PRIMARY Improvement in Cognitive Function- CPT Hits Rate (Proportion)	0.03; 0.09	—
PRIMARY Improvement in Cognitive Function- CPT Reaction Time of Hits (Milliseconds)	8.5; -13.8	—
PRIMARY Improvement in Cognitive Function- CPT False Alarm Rate (Proportion)	-0.03; 0.02	—

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00646581). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.