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The Effect of Intranasal Insulin on Neurocognitive Function in Euthymic Patients With Bipolar Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00314314
Recruitment Status : Completed
First Posted : April 13, 2006
Last Update Posted : July 13, 2009
Hamilton Health Sciences Corporation
Information provided by:
University Health Network, Toronto

Brief Summary:
It is hypothesized that the intranasal administration of insulin will enhance hippocampal-dependent neurocognitive performance in euthymic patients with bipolar I or II disorder. This novel initiative represents a proof-of-concept study that insulin is salient to neurocognitive functioning and deficits in bipolar disorder and represents a novel and safe therapeutic avenue. The available literature suggests that the acute administration of intranasal insulin enhances cognition in memory impaired older adults with either Alzheimer's disease or minimal cognitive impairment. Prior research demonstrates a cognitive enhancing effect of insulin within one hour of the first intranasal insulin dose. Other studies suggest that the long-term administration of intranasal insulin (i.e. over eight weeks) in enhances memory performance in human volunteers. We aim to evaluate the acute and long-term effects of intranasal insulin administration in persons with bipolar disorder. As such we will be conducting the neuropsychological testing at three time points, the week before receiving insulin, within one hour of the first dose and after 8 weeks of insulin administration.

Condition or disease Intervention/treatment Phase
Bipolar Disorder Drug: Intranasal Insulin Drug: Diluent Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind Controlled Trial Evaluating the Effect of Intranasal Insulin on Neurocognitive Function in Euthymic Patients With Bipolar Disorder
Study Start Date : May 2006
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

Arm Intervention/treatment
Experimental: 1 Drug: Intranasal Insulin
Intranasal spray; 40 IU qid; 8 weeks

Placebo Comparator: 2 Drug: Diluent
Intranasal spray; 8 weeks

Primary Outcome Measures :
  1. Cognitive Tests: CVLT, Process Dissociation Tasks [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Cognitive Tests: Trails A [ Time Frame: 8 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Bipolar I Disorder - Euthymic
  • Bipolar II Disorder - Euthymic

Exclusion Criteria:

  • Unstable Medical Conditions
  • Currently Manic, Depressed or Mixed

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00314314

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Canada, Ontario
Toronto Western Hospital
Toronto, Ontario, Canada, M5T 2S8
Sponsors and Collaborators
University Health Network, Toronto
Hamilton Health Sciences Corporation
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Principal Investigator: Roger McIntyre, MD, FRCPC University Health Network, Toronto

Additional Information:
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Responsible Party: Roger S. McIntyre, University Health Network Identifier: NCT00314314    
Other Study ID Numbers: Insulin
First Posted: April 13, 2006    Key Record Dates
Last Update Posted: July 13, 2009
Last Verified: May 2008
Keywords provided by University Health Network, Toronto:
Bipolar Disorder, memory, executive functioning
Additional relevant MeSH terms:
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Bipolar Disorder
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs