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The Effect of Intranasal Insulin on Neurocognitive Function in Euthymic Patients With Bipolar Disorder
This study is currently recruiting participants.
Verified by University Health Network, Toronto, May 2008
First Received: April 11, 2006   Last Updated: March 12, 2009   History of Changes
Sponsors and Collaborators: University Health Network, Toronto
Hamilton Health Sciences
Information provided by: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT00314314
  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 III

MedlinePlus related topics: Bipolar Disorder Memory
Drug Information available for: Insulin
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Randomized, Double-Blind Controlled Trial Evaluating the Effect of Intranasal Insulin on Neurocognitive Function in Euthymic Patients With Bipolar Disorder

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
Estimated Study Completion Date: June 2009
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Drug: Intranasal Insulin
Intranasal spray; 40 IU qid; 8 weeks
2: Placebo Comparator 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00314314

Contacts
Contact: Hanna Woldeyohannes, BSc 416-603-5133 hanna.woldeyohannes@uhn.on.ca
Contact: Joanna Soczynska, BSc 416-603-5800 ext 3726 joanna.soczynska@uhn.on.ca

Locations
Canada, Ontario
Toronto Western Hospital Recruiting
Toronto, Ontario, Canada, M5T 2S8
Contact: Hanna Woldeyohannes, BSc     416-603-5800 ext 3219     hanna.woldeyohannes@uhn.on.ca    
Principal Investigator: Roger S McIntyre            
Sponsors and Collaborators
University Health Network, Toronto
Hamilton Health Sciences
Investigators
Principal Investigator: Roger McIntyre, MD, FRCPC University Health Network, Toronto
  More Information

Additional Information:
No publications provided

Responsible Party: University Health Network ( Roger S. McIntyre )
Study ID Numbers: Insulin
Study First Received: April 11, 2006
Last Updated: March 12, 2009
ClinicalTrials.gov Identifier: NCT00314314     History of Changes
Health Authority: Canada: Health Canada

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

Study placed in the following topic categories:
Affective Disorders, Psychotic
Hypoglycemic Agents
Mental Disorders
Bipolar Disorder
Mood Disorders
Psychotic Disorders
Insulin

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

ClinicalTrials.gov processed this record on May 07, 2009