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

This study has been completed.
Sponsor:
Collaborator:
Hamilton Health Sciences Corporation
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00314314
First received: April 11, 2006
Last updated: July 9, 2009
Last verified: May 2008
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cognitive Tests: Trails A [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Unstable Medical Conditions
  • Currently Manic, Depressed or Mixed
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00314314

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

Additional Information:
No publications provided

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

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

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 26, 2014