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

This study has been completed.
Hamilton Health Sciences Corporation
Information provided by:
University Health Network, Toronto Identifier:
First received: April 11, 2006
Last updated: July 9, 2009
Last verified: May 2008
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 Intervention Phase
Bipolar Disorder Drug: Intranasal Insulin Drug: Diluent Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by University Health Network, Toronto:

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

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

Estimated Enrollment: 60
Study Start Date: May 2006
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Intranasal Insulin
Intranasal spray; 40 IU qid; 8 weeks
Placebo Comparator: 2 Drug: Diluent
Intranasal spray; 8 weeks

  Show Detailed Description


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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00314314

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

Additional Information:
Responsible Party: Roger S. McIntyre, University Health Network Identifier: NCT00314314     History of Changes
Other Study ID Numbers: Insulin
Study First Received: April 11, 2006
Last Updated: July 9, 2009

Keywords provided by University Health Network, Toronto:
Bipolar Disorder, memory, executive functioning

Additional relevant MeSH terms:
Bipolar Disorder
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on September 21, 2017