Clinical trial NCT00646581: Effect of Single Dose Intranasal Insulin On Cognitive Function
Official title: Effect of Single Dose Intranasal Insulin on Cognitive Function in Patients With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Schizoaffective Disorder
Keywords: Schizophrenia
Memory
Concentration
Insulin
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
First posted: 2008-03-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Improvement in Cognitive Function- HVLT Immediate Recall Total (Number)
timeFrame: pretreatment= in the morning; postreatment= in the afternoon, 30 minutes after intranasal spray administration
measure: Improvement in Cognitive Function- HVLT-Delayed Recall (Number)
timeFrame: pretreatment= in the morning; postreatment= in the afternoon, 30 minutes after intranasal spray administration
measure: CPT d Score
timeFrame: pretreatment= in the morning; postreatment= in the afternoon, 30 minutes after intranasal spray administration
measure: Improvement in Cognitive Function- CPT Hits Rate (Proportion)
timeFrame: pretreatment= in the morning; postreatment= in the afternoon, 30 minutes after intranasal spray administration
measure: Improvement in Cognitive Function- CPT Reaction Time of Hits (Milliseconds)
timeFrame: pretreatment= in the morning; postreatment= in the afternoon, 30 minutes after intranasal spray administration
measure: Improvement in Cognitive Function- CPT False Alarm Rate (Proportion)
timeFrame: pretreatment= in the morning; postreatment= in the afternoon, 30 minutes after intranasal spray administration
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Freedom Trail Clinic
state: Massachusetts
Study officials:
affiliation: UMass Medical School
name: Xiaoduo Fan, MD, MPH, MS
role: PRINCIPAL_INVESTIGATOR
References: