Ignite Creation Date:
2024-05-05 @ 4:47 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00314314
Status:
COMPLETED
Last Update Posted:
2009-07-13
First Post:
2006-04-11
Brief Title:
The Effect of Intranasal Insulin on Neurocognitive Function in Euthymic Patients With Bipolar Disorder
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
A Randomized Double-Blind Controlled Trial Evaluating the Effect of Intranasal Insulin on Neurocognitive Function in Euthymic Patients With Bipolar Disorder
Status:
COMPLETED
Status Verified Date:
2008-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Alzheimers 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 ie 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
Detailed Description:
Sixty verified euthymic individuals age 18-60 with DSM-IV-TR defined Bipolar Disorder diagnosis will be confirmed by the Mini International Neuropsychiatric Interview for the DSM-IV will be enrolled Individuals below the age of 18 and over 60 are excluded as they are not seen at the recruiting center Enrollment into the study is voluntary Eligible subjects will provide written informed consent Subjects will be enrolled from the outpatient Mood Disorders Psychopharmacology Unit MDPU University health Network University of Toronto Study information and consent procedures will be provided by personnel other than the primary treatment provider
Euthymia the absence of clinically meaningful symptoms will be prospectively defined as a score of 3 or less with the Hamilton Rating Scale for Depression 7 item HAMD-7 and a score of 7 or less on the Young Mania Rating Scale YMRS at initial assessment and at 1 month baseline The HAMD-7 and YMRS will be repeated at every follow-up visit
Conventional pharmacological treatments for bipolar disorder will be permitted eg Lithium anticonvulsant mood stabilizers antipsychotics antidepressants anxiolyticshypnotics etc Medication regimens will remain stable throughout the duration of the study Enrollment into the study is voluntary Eligible subjects will provide written informed consent Study information and consent procedures will be provided by personnel other than the primary treatment provider Subjects will be enrolled from the outpatient Mood Disorders Psychopharmacology Unit University Health Network University of Toronto Illness characteristics will be obtained from the patient interview and hospital medical records
Subjects will be compensated for sundry expenses ie parking public transport Subjects will not receive financial compensation for being a participant in the study The ongoing provision of care is not contingent on enrollment andor completion of the study protocol
Subjects will be excluded if they are receiving corticosteroids or antihypertensive medications another current Axis I psychiatric disorder a neurological or medically unstable condition substance or alcohol misuse in the past 3 months or electroconvulsive therapy in the last year Other exclusion criteria include the presence of diabetes mellitus or hyperglycemia BMI equal or greater than 40 kgm2 or inability to provide written informed consent Patients who are actively suicidal or evaluated as being a suicide risk will be excluded Other reasons for discontinuation are voluntary discontinuation failure to complete 1 month of euthymia impaired fasting glucose ie 61-69 mmolL non-compliance ie failure to administer 80 of the assigned treatment in any week Insulin will be measured quantitatively on a weekly basis subjects will also complete a diary of when they took intranasal insulin and their prescribed medication
The ongoing provision of care is not contingent on enrollment andor completion of the study protocol Furthermore there will be ongoing communication with the subjects primary care provider in regards to their participation in this study
This is a randomized double-blind placebo-controlled parallel-group study
The initial visit entails the provision of detailed study information to a subject and obtainment of written informed consent from the subject The subject will then meet a research team member at a later date for a screening visit This study requires a total of 12 visits
Neuropsychological testing will be conducted at 3 time points
1 Baseline Visit 3
2 Within 60 minutes of the first administration of randomized treatment Visit 4
3 Endpoint Visit 12
Euthymia the absence of clinically meaningful symptoms will be prospectively defined as a score of 3 or less with the Hamilton Rating Scale for Depression 7 item HAMD-7 and a score of 7 or less on the Young Mania Rating Scale YMRS at initial assessment and at 1 month baseline The HAMD-7 and YMRS will be repeated at every follow-up visit
Conventional pharmacological treatments for bipolar disorder will be permitted eg Lithium anticonvulsant mood stabilizers antipsychotics antidepressants anxiolyticshypnotics etc Medication regimens will remain stable throughout the duration of the study Enrollment into the study is voluntary Eligible subjects will provide written informed consent Study information and consent procedures will be provided by personnel other than the primary treatment provider Subjects will be enrolled from the outpatient Mood Disorders Psychopharmacology Unit University Health Network University of Toronto Illness characteristics will be obtained from the patient interview and hospital medical records
Subjects will be compensated for sundry expenses ie parking public transport Subjects will not receive financial compensation for being a participant in the study The ongoing provision of care is not contingent on enrollment andor completion of the study protocol
Subjects will be excluded if they are receiving corticosteroids or antihypertensive medications another current Axis I psychiatric disorder a neurological or medically unstable condition substance or alcohol misuse in the past 3 months or electroconvulsive therapy in the last year Other exclusion criteria include the presence of diabetes mellitus or hyperglycemia BMI equal or greater than 40 kgm2 or inability to provide written informed consent Patients who are actively suicidal or evaluated as being a suicide risk will be excluded Other reasons for discontinuation are voluntary discontinuation failure to complete 1 month of euthymia impaired fasting glucose ie 61-69 mmolL non-compliance ie failure to administer 80 of the assigned treatment in any week Insulin will be measured quantitatively on a weekly basis subjects will also complete a diary of when they took intranasal insulin and their prescribed medication
The ongoing provision of care is not contingent on enrollment andor completion of the study protocol Furthermore there will be ongoing communication with the subjects primary care provider in regards to their participation in this study
This is a randomized double-blind placebo-controlled parallel-group study
The initial visit entails the provision of detailed study information to a subject and obtainment of written informed consent from the subject The subject will then meet a research team member at a later date for a screening visit This study requires a total of 12 visits
Neuropsychological testing will be conducted at 3 time points
1 Baseline Visit 3
2 Within 60 minutes of the first administration of randomized treatment Visit 4
3 Endpoint Visit 12
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None