|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT00570050 |
|
Date of registration:
|
06/12/2007 |
|
Primary sponsor: |
|
|
Public title:
|
The Effect of Intranasal Insulin on Neurocognitive Function in Euthymic Patients With Major Depressive Disorder
|
|
Scientific title:
|
A Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Effect of Intranasal Insulin on Neurocognitive Function in Euthymic Individuals With Major Depressive Disorder |
|
Date of first enrolment:
|
December 2007 |
|
Target sample size:
|
90 |
|
Recruitment status: |
Recruiting |
|
URL:
|
http://clinicaltrials.gov/show/NCT00570050 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
|
|
|
Countries of recruitment
|
|
Canada
| | | | | | | |
|
Contacts
|
|
Name:
|
Hanna O Woldeyohannes |
|
Address:
|
|
|
Telephone:
|
416-603-5800 |
|
Email:
|
hanna.woldeyohannes@uhn.on.ca |
|
Affiliation:
|
|
|
|
Name:
|
Hanna O Woldeyohannes |
|
Address:
|
|
|
Telephone:
|
416-603-5133 |
|
Email:
|
hanna.woldeyohannes@uhn.on.ca |
|
Affiliation:
|
|
|
|
Name:
|
Roger S McIntyre |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
University Health Network, Toronto |
|
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Major Depressive Disorder - Euthymic
Exclusion Criteria:
- Unstable medical conditions
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Major Depressive Disorder
|
|
Intervention(s)
|
|
Drug: Diluent
|
|
Drug: Intranasal Insulin
|
|
Primary Outcome(s)
|
|
California Verbal Learning Test (CVLT) Second Edition - Adult Version
[Time Frame: 9 weeks]
|
|
Secondary Outcome(s)
|
|
Backward Masking Task; Trails A; Trails B; Continuous Visual Memory Test (CVMT); Process Dissociation Task (HABCON); Digit Symbol Substitution; Word Fluency; Cognitive Functioning Questionnaire
[Time Frame: 9 weeks]
|
|
Secondary ID(s)
|
|
Insulin-MDD
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|