Effect of Single Dose Intranasal Insulin On Cognitive Function

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Xiaoduo Fan, University of Massachusetts, Worcester

ClinicalTrials.gov Identifier:

NCT00646581

First received: January 31, 2008

Last updated: February 12, 2013

Last verified: February 2013

History of Changes

Results First Received: August 17, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator); Primary Purpose: Treatment
Conditions:	Schizophrenia Schizoaffective Disorder
Interventions:	Drug: Placebo Drug: Insulin (Humulin)

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were recruited from an urban community mental health clinic.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects who met DSM-IV criteria for schizophrenia or schizoaffective disorder were enrolled in the study (see inclusion/exclusion criteria). Subjects were randomly assigned to either the experimental group or placebo group.

Reporting Groups

	Description
Placebo (1)	Subjects are given a one-time, single dose of placebo intranasal spray
Single-Dose Intranasal Insulin	Subjects are given a one-time, single dose of intranasal insulin

Participant Flow: Overall Study

	Placebo (1)	Single-Dose Intranasal Insulin
STARTED	15	15
COMPLETED	15	15
NOT COMPLETED	0	0

Baseline Characteristics

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Reporting Groups

	Description
Placebo (1)	Subjects are given a one-time, single dose of placebo intranasal spray
Single-Dose Intranasal Insulin	Subjects are given a one-time, single dose of intranasal insulin
Total	Total of all reporting groups

Baseline Measures

	Placebo (1)	Single-Dose Intranasal Insulin	Total
Number of Participants [units: participants]	15	15	30
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	15	15	30
>=65 years	0	0	0
Gender [units: participants]
Female	10	10	20
Male	5	5	10
Region of Enrollment [units: participants]
United States	15	15	30

Outcome Measures

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1. Primary:

Improvement in Cognitive Function- HVLT Immediate Recall Total (Number) [ Time Frame: pretreatment= in the morning; postreatment= in the afternoon, 30 minutes after intranasal spray administration ]

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2. Primary:

Improvement in Cognitive Function- HVLT-Delayed Recall (Number) [ Time Frame: pretreatment= in the morning; postreatment= in the afternoon, 30 minutes after intranasal spray administration ]

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3. Primary:

CPT d Score [ Time Frame: pretreatment= in the morning; postreatment= in the afternoon, 30 minutes after intranasal spray administration ]

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4. Primary:

Improvement in Cognitive Function- CPT Hits Rate (Proportion) [ Time Frame: pretreatment= in the morning; postreatment= in the afternoon, 30 minutes after intranasal spray administration ]

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5. Primary:

Improvement in Cognitive Function- CPT Reaction Time of Hits (Milliseconds) [ Time Frame: pretreatment= in the morning; postreatment= in the afternoon, 30 minutes after intranasal spray administration ]

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6. Primary:

Improvement in Cognitive Function- CPT False Alarm Rate (Proportion) [ Time Frame: pretreatment= in the morning; postreatment= in the afternoon, 30 minutes after intranasal spray administration ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Matthew Goodnow
Organization: UMass Medical School
phone: 508-856-2494
e-mail: matthew.goodnow@umassmed.edu

No publications provided

Responsible Party:	Xiaoduo Fan, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier:	NCT00646581 History of Changes
Other Study ID Numbers:	4-2006, CORRC tracking number: 4-2006
Study First Received:	January 31, 2008
Results First Received:	August 17, 2012
Last Updated:	February 12, 2013
Health Authority:	United States: Institutional Review Board

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