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Sponsors and Collaborators: |
University Health Network, Toronto Hamilton Health Sciences |
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Information provided by: | University Health Network, Toronto |
ClinicalTrials.gov Identifier: | NCT00314314 |
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 |
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Bipolar Disorder |
Drug: Intranasal Insulin Drug: Diluent |
Phase III |
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 |
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 |
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1: Experimental |
Drug: Intranasal Insulin
Intranasal spray; 40 IU qid; 8 weeks
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2: Placebo Comparator |
Drug: Diluent
Intranasal spray; 8 weeks
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Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
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 |
Principal Investigator: | Roger McIntyre, MD, FRCPC | University Health Network, Toronto |
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 |
Bipolar Disorder, memory, executive functioning |
Affective Disorders, Psychotic Hypoglycemic Agents Mental Disorders Bipolar Disorder |
Mood Disorders Psychotic Disorders Insulin |
Affective Disorders, Psychotic Hypoglycemic Agents Pathologic Processes Disease Mental Disorders |
Bipolar Disorder Physiological Effects of Drugs Mood Disorders Pharmacologic Actions Insulin |