- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00998569
Neurocognitive Enhancement in Major Depressive Disorder (MDDNET)
August 27, 2015 updated by: Christopher Bowie, Queen's University
The purpose of this study is to examine the effects of neurocognitive enhancement on cognitive abilities and related social and adaptive behaviours in individuals diagnosed with major depressive disorder.
Subjects in this study will be randomized to receive Neurocognitive Enhancement Therapy (NET) or to a wait list and then NET .
Secondary aims include examining whether the cognitive benefits are potentiated by repeated exposure during in-home practice with complementary exercises.
Additionally, the investigators will examine the durability of the effects and their generalization to functional capacity and everyday functional performance after completion of the groups.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
33
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Kingston, Ontario, Canada, K7L 3N6
- Queen's University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male or Female.
- Subjects will be between the ages of 18 and 65, which is the age range with available normative comparison data.
Exclusion Criteria:
- Presence of a medical diagnosis that is associated with known cognitive impairments, such as multiple sclerosis, cerebrovascular accident, dementia, or history of traumatic brain injury.
- Subjects with a reading level below grade 6, as assessed with the Wide Range Achievement Test - Reading Recognition Subtest, will be excluded because of the likelihood of not understanding task instructions.
- Subjects with uncorrectable vision or hearing impairment that would preclude valid assessments or intervention procedures.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Neurocognitive Enhancement
neurocongnitive enhancement
|
Neurocognitive Enhancement Therapy (NET) uses behavioural treatment strategies that are designed to improve a range of cognitive skills.
NET uses strategies such as coaching, repetition, practice, teaching, group discussion, and compensation for deficits by using cognitive strengths.
|
Other: Wait List
no intervention
|
Participants will be wait listed for 10 weeks, following which time they will receive the intervention previously described.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Performance on paper and pencil assessments of neurocognition after treatment, compared to baseline assessment performance
Time Frame: 20 weeks
|
20 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Christopher Bowie, PhD, Queen's University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2009
Primary Completion (Actual)
March 1, 2012
Study Completion (Actual)
March 1, 2012
Study Registration Dates
First Submitted
October 14, 2009
First Submitted That Met QC Criteria
October 19, 2009
First Posted (Estimate)
October 20, 2009
Study Record Updates
Last Update Posted (Estimate)
August 31, 2015
Last Update Submitted That Met QC Criteria
August 27, 2015
Last Verified
August 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PSYC-092-09
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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