Computerized Cognitive Remediation for Geriatric Depression
Primary Purpose
Major Depressive Disorder, Major Depressive Episode
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
computerized cognitive remediation
computerized cognitive remediation:Control
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder focused on measuring Executive Dysfunction, Cognitive Remediation, Geriatric, Depression
Eligibility Criteria
Inclusion Criteria:
Medicated Depressed Participants' Inclusion Criteria
- Age: 60-89 years
- Diagnosis: Major depression, unipolar (by DSM-IV criteria);
- Severity of depression: MADRS >or =15 following at least 8-weeks of controlled antidepressant treatment.
- No plans to change current antidepressant treatment.
Non-Medicated Depressed Participants' Inclusion Criteria
- Age: 60-89 years
- Diagnosis: Major depression, unipolar (by DSM-IV criteria);
- Severity of depression: MADRS >or =15
- No antidepressant treatment within the current episode. -
Exclusion Criteria:
- Psychotic depression by DSM-IV, i.e., presence of delusions with a score higher than 2 (questionable delusion) rated by the Scale for Assessment of Positive Symptoms (SAPS) [47];
- High suicide risk, i.e. intent or plan to attempt suicide in near future;
- Presence of any Axis I psychiatric disorder (other than unipolar major depression) or substance abuse; Axis II diagnosis of antisocial personality (by SCID-P and DSM-IV);
- History of psychiatric disorders other than unipolar major depression or generalized anxiety disorder (bipolar disorder, hypomania, and dysthymia are exclusion criteria);
- Dementia: Mattis Dementia Rating Scale scores below 130 or diagnosis of dementia by DSM-IV; multiple sclerosis, history of head trauma or history of electroconvulsive therapy;
- Amnestic Mild Cognitive Impairment (a-MCI), or Multiple Domain Mild Cognitive Impairment (md-MCI);
- Acute or severe medical illness, i.e., delirium, metastatic cancer, decompensated cardiac, liver or kidney failure, major surgery, stroke or myocardial infarction during the three months prior to entry; or drugs known to cause depression, e.g., reserpine, alpha-methyl-dopa, steroids, sympathomimetics withdrawal;
- Presence of a neurological brain disease and/or history of electroconvulsive therapy;
- Current involvement in psychotherapy;
- Inability to perform any of the ADLs (MAI: ADL subscale) even with assistance, e.g. walking with a cane is not an exclusion criterion;
- Inability to speak English;
- Aphasia;
- Corrected visual acuity < 20/70; Color blindness -
Sites / Locations
- Weill Cornell Medical CollegeRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Computer Treatment: Active
Computer Treatment: Control
Arm Description
Computerized Cognitive Remediation: Targeted to underlying cerebral networks associated with remission.
Computerized Cognitive Remediation: Non-targeted
Outcomes
Primary Outcome Measures
Montgomery-Asberg Depression Rating Scale
10 item measure to assess the core symptoms and cognitive features of clinical depression
Secondary Outcome Measures
Full Information
NCT ID
NCT01979289
First Posted
October 25, 2013
Last Updated
February 1, 2017
Sponsor
Weill Medical College of Cornell University
1. Study Identification
Unique Protocol Identification Number
NCT01979289
Brief Title
Computerized Cognitive Remediation for Geriatric Depression
Official Title
Computerized Cognitive Remediation for Geriatric Depression
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 2012 (undefined)
Primary Completion Date
July 2017 (Anticipated)
Study Completion Date
July 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This research study will examine if a targeted computerized cognitive remediation (CCR) training program is better for treating geriatric depression than general computer activity. We will also examine whether this intervention is related to improvement in cognitive and depressive symptoms. Elderly patients with depression, who have, and who have not been treated with antidepressant medication for their illness, will be recruited to participate in either a 30 hour cognitive remediation program or general computer activity designed to be both challenging and interesting. They will be asked to complete between 1 and 3 hours of remediation per day over 4 weeks. While undergoing the cognitive remediation participants will be asked questions to assess their symptoms of, as well as the severity of, their depression weekly. This will inform researchers about whether or not the CCR is helping to improve depressive symptoms. At the end of the CCR study, participants will be given a battery of cognitive tests design to tell investigators whether or not the CCR improved their thinking in a variety of different ways including improving attention, memory, and organization. Investigators will also determine whether changes in participants' thinking are related to changes in their mood or other depressive symptoms. It is hoped that information gained from this study will help investigators to better understand the brain processes associated with depression, recovery from depression, and will help inform the development of future alternative treatments for this illness.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder, Major Depressive Episode
Keywords
Executive Dysfunction, Cognitive Remediation, Geriatric, Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Computer Treatment: Active
Arm Type
Experimental
Arm Description
Computerized Cognitive Remediation: Targeted to underlying cerebral networks associated with remission.
Arm Title
Computer Treatment: Control
Arm Type
Active Comparator
Arm Description
Computerized Cognitive Remediation: Non-targeted
Intervention Type
Other
Intervention Name(s)
computerized cognitive remediation
Intervention Type
Other
Intervention Name(s)
computerized cognitive remediation:Control
Primary Outcome Measure Information:
Title
Montgomery-Asberg Depression Rating Scale
Description
10 item measure to assess the core symptoms and cognitive features of clinical depression
Time Frame
4-6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Medicated Depressed Participants' Inclusion Criteria
Age: 60-89 years
Diagnosis: Major depression, unipolar (by DSM-IV criteria);
Severity of depression: MADRS >or =15 following at least 8-weeks of controlled antidepressant treatment.
No plans to change current antidepressant treatment.
Non-Medicated Depressed Participants' Inclusion Criteria
Age: 60-89 years
Diagnosis: Major depression, unipolar (by DSM-IV criteria);
Severity of depression: MADRS >or =15
No antidepressant treatment within the current episode. -
Exclusion Criteria:
Psychotic depression by DSM-IV, i.e., presence of delusions with a score higher than 2 (questionable delusion) rated by the Scale for Assessment of Positive Symptoms (SAPS) [47];
High suicide risk, i.e. intent or plan to attempt suicide in near future;
Presence of any Axis I psychiatric disorder (other than unipolar major depression) or substance abuse; Axis II diagnosis of antisocial personality (by SCID-P and DSM-IV);
History of psychiatric disorders other than unipolar major depression or generalized anxiety disorder (bipolar disorder, hypomania, and dysthymia are exclusion criteria);
Dementia: Mattis Dementia Rating Scale scores below 130 or diagnosis of dementia by DSM-IV; multiple sclerosis, history of head trauma or history of electroconvulsive therapy;
Amnestic Mild Cognitive Impairment (a-MCI), or Multiple Domain Mild Cognitive Impairment (md-MCI);
Acute or severe medical illness, i.e., delirium, metastatic cancer, decompensated cardiac, liver or kidney failure, major surgery, stroke or myocardial infarction during the three months prior to entry; or drugs known to cause depression, e.g., reserpine, alpha-methyl-dopa, steroids, sympathomimetics withdrawal;
Presence of a neurological brain disease and/or history of electroconvulsive therapy;
Current involvement in psychotherapy;
Inability to perform any of the ADLs (MAI: ADL subscale) even with assistance, e.g. walking with a cane is not an exclusion criterion;
Inability to speak English;
Aphasia;
Corrected visual acuity < 20/70; Color blindness -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Coluccio, M.A.
Phone
914-997-4327
First Name & Middle Initial & Last Name or Official Title & Degree
Institute of Geriatric Psychiatry
Phone
914-997-4331
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah Shizuko Morimoto, Psy.D.
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Cornell Medical College
City
White Plains
State/Province
New York
ZIP/Postal Code
10605
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Shizuko Morimoto, Psy.D.
12. IPD Sharing Statement
Learn more about this trial
Computerized Cognitive Remediation for Geriatric Depression
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