- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00570050
Effect of Intranasal Insulin on Depressive Symptoms in Major Depressive Disorder
A Randomized, Double-blind, Placebo-controlled Cross-over Trial Evaluating the Effect of Intranasal Insulin on Depressive Symptoms in Individuals With Major Depressive Disorder Insufficiently Responsive to Antidepressant Therapy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Emerging evidence for impairments at the cognitive-affective interface, frequently defined as affective cognition, are increasingly being recognized as a core feature of mood disorders, particularly MDD. Individuals with MDD consistently exhibit abnormalities in verbal memory with particular difficulty in memory tasks such as list learning and free recall. The administration of intranasal insulin has been reported to improve verbal memory, declarative memory in individuals with Alzheimer's disease or Mild Cognitive Impairment as well as measures of mood (e.g., overall feeling of well-being, self-esteem, and depression) in healthy volunteers. The effect of intranasal insulin on any measure of neurocognitive function and emotional processing in MDD is currently unknown.
Thirty participants between the ages of 18 and 60 with DSM-IV-TR defined MDD [confirmed by the Mini International Neuropsychiatric Interview (MINI)] 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 participants will provide written informed consent. Participants will be enrolled from the outpatient Mood Disorders Psychopharmacology Unit (MDPU), University Health Network (UHN), University of Toronto.
The MDPU case report form will gather information on the participant's course of illness variables. Conventional pharmacological treatments for MDD will be permitted (e.g., conventional antidepressants). Conventional unimodal antidepressants modulate cerebral glucose metabolism; as such, they will be kept consistent throughout the duration of the study and will not be altered from the point of randomization to study endpoint. Antidepressants and augmentation strategies with significant anti-cholinergic potential (e.g., paroxetine, tricyclic antidepressants) as well as benzodiazepines will be exclusionary as they may negatively affect neurocognitive function.
Participants will be excluded if they are receiving corticosteroids or antihypertensive medications; misused substance or alcohol in the past 3 months; received electroconvulsive therapy in the last 1 year; or have a neurological or medically unstable condition. Another exclusion criterion includes the inability to provide written informed consent. The Montgomery-Asberg Depression Rating Scale (MADRS) and Hamilton Depression Rating Scale 17-Item (HAM-D-17) will be administered at baseline and weekly throughout the 8 weeks of treatment assignment. Participants who are actively suicidal or evaluated as being a suicide risk will also be excluded. Other reasons for discontinuation are impaired fasting glucose (i.e., 6.1 - 6.9 mmol/L), and non-compliance (i.e., failure to administer ≥ 80% of the assigned treatment in any week).
The ongoing provision of care is not contingent on enrollment and/or completion of the study protocol. Furthermore, there will be ongoing communication with the participant's primary care provider in regards to their participation in this study.
This is a randomized double-blind, placebo-controlled, cross-over study. The initial visit entails the provision of detailed study information to the patient and obtainment of written informed consent from the participant. The participant will then meet a research team member at a later date for a screening visit. This study requires a total of 12 visits.
Full neuropsychological testing will be conducted at 4 time points:
- Baseline1 (Visit 3)
- Endpoint1 (Visit 7)
- Baseline2 (Visit 8)
- Endpoint2 (Visit 12)
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5T 2S8
- Toronto Western Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Major Depressive Disorder - current depression
Exclusion Criteria:
- Unstable medical conditions
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intranasal Insulin nasal spray
|
Diluent (4 Weeks ) / Intranasal insulin (4 weeks)
Intranasal Insulin (4 Weeks ) / Diluent (4 Weeks)
|
Experimental: Placebo nasal spray (i.e., no active treatment)
|
Diluent (4 Weeks ) / Intranasal insulin (4 weeks)
Intranasal Insulin (4 Weeks ) / Diluent (4 Weeks)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Montgomery-Asberg Depression Rating Scale
Time Frame: 9 weeks
|
Score form baseline to end of each treatment phase.
|
9 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Affective Go/No-Go and Emotional Recognition Tasks; CGI Severity of Illness, Improvements in subjective mood (PANAS) and quality of life (Q-LES-Q)
Time Frame: 9 weeks
|
9 weeks
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Roger S McIntyre, University Health Network, Toronto
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Insulin-MDD
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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