Back to resultsCognitive Training for Depression
Primary Purpose
Major Depressive Disorder
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cognitive Training A
Cognitive Training B
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder focused on measuring Cognitive training, Depression
Eligibility Criteria
Inclusion Criteria:
- Primary, current Axis I diagnosis of Major Depressive Disorder according to DSM-IV criteria and Ham-D-17 score between 16-27
- Age 18-55
- Able to give informed consent
Exclusion Criteria:
- A history of drug or alcohol abuse or dependence (DSM-IV criteria) within 6 months
- Visual impairment that would affect the ability to observe the computerized presentation of faces.
- Motor impairment that would affect the ability to provide a response by quickly pressing a button.
- Lifetime history of Bipolar spectrum disorders or schizophrenia spectrum disorders.
- Primary, current Axis I diagnosis other than Major Depressive Disorder
- Primary, current Axis II personality disorder.
- Currently attending a cognitive-behavioral psychotherapy regimen
- Acute suicidal or homicidal risk (evidenced by suicidal or homicidal attempt within 6 months of screening)
- Pregnancy in women.
Subjects must exhibit no or only moderate alcohol use. Subjects with current excessive use of alcohol (> 8 ounces/day for men and > 6 ounces/day for women) are ineligible for participation, as such drug use could confound the results.
Sites / Locations
- Icahn School of Medicine at Mount Sinai
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Cognitive Training A
Cognitive Training B
Arm Description
emotional memory training exercise
memory training exercise
Outcomes
Primary Outcome Measures
change in Hamilton Depression Rating Scale (Ham-D)
Change in depression symptom severity at week 4 compared as to baseline
Secondary Outcome Measures
change in Self-referential Information Processing Task
change in Negative Affective Bias at week 4 as compared to baseline
change in Working Memory
change in Neurocognition at week 4 as compared to baseline
Full Information
NCT ID
NCT01936506
First Posted
August 29, 2013
Last Updated
September 3, 2013
Sponsor
Icahn School of Medicine at Mount Sinai
1. Study Identification
Unique Protocol Identification Number
NCT01936506
Brief Title
Cognitive Training for Depression
Official Title
Cognitive Training for Depression
Study Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Icahn School of Medicine at Mount Sinai
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study is evaluating the effects of two brain training exercises on: memory, cognitive processing and depression symptoms.
Detailed Description
There is an urgent public health need to develop more effective and well tolerated treatments for patients with major depressive disorder (MDD); cognitive training interventions aiming to modify cognitive and affective processing abnormalities underlying MDD represent a promising new strategy. This research project translates a well established cognitive bias in major depressive disorder (MDD), working memory bias, into a novel intervention target. In a double-blind, randomized, controlled study, MDD participants undergo 4 weeks of cognitive training sessions, with two sessions per week.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Cognitive training, Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cognitive Training A
Arm Type
Experimental
Arm Description
emotional memory training exercise
Arm Title
Cognitive Training B
Arm Type
Active Comparator
Arm Description
memory training exercise
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Training A
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Training B
Primary Outcome Measure Information:
Title
change in Hamilton Depression Rating Scale (Ham-D)
Description
Change in depression symptom severity at week 4 compared as to baseline
Time Frame
baseline and week 4
Secondary Outcome Measure Information:
Title
change in Self-referential Information Processing Task
Description
change in Negative Affective Bias at week 4 as compared to baseline
Time Frame
baseline and week 4
Title
change in Working Memory
Description
change in Neurocognition at week 4 as compared to baseline
Time Frame
baseline and week 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Primary, current Axis I diagnosis of Major Depressive Disorder according to DSM-IV criteria and Ham-D-17 score between 16-27
Age 18-55
Able to give informed consent
Exclusion Criteria:
A history of drug or alcohol abuse or dependence (DSM-IV criteria) within 6 months
Visual impairment that would affect the ability to observe the computerized presentation of faces.
Motor impairment that would affect the ability to provide a response by quickly pressing a button.
Lifetime history of Bipolar spectrum disorders or schizophrenia spectrum disorders.
Primary, current Axis I diagnosis other than Major Depressive Disorder
Primary, current Axis II personality disorder.
Currently attending a cognitive-behavioral psychotherapy regimen
Acute suicidal or homicidal risk (evidenced by suicidal or homicidal attempt within 6 months of screening)
Pregnancy in women.
Subjects must exhibit no or only moderate alcohol use. Subjects with current excessive use of alcohol (> 8 ounces/day for men and > 6 ounces/day for women) are ineligible for participation, as such drug use could confound the results.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian M Iacoviello, PhD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Cognitive Training for Depression
We'll reach out to this number within 24 hrs