Computerized Cognitive Remediation for Geriatric Depression

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.

Study Overview

• Status: Unknown
• Conditions: Major Depressive Disorder; Major Depressive Episode
• Intervention / Treatment: Other: computerized cognitive remediation; Other: computerized cognitive remediation:Control

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maria Coluccio, M.A.; Phone Number: 914-997-4327
• Study Contact Backup: Name: Institute of Geriatric Psychiatry; Phone Number: 914-997-4331

Study Locations

• United States
  • New York
    • White Plains, New York, United States, 10605
      • Recruiting
      • Weill Cornell Medical College
      • Principal Investigator: Sarah Shizuko Morimoto, Psy.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Medicated Depressed Participants' Inclusion Criteria

1. Age: 60-89 years
2. Diagnosis: Major depression, unipolar (by DSM-IV criteria);
3. Severity of depression: MADRS >or =15 following at least 8-weeks of controlled antidepressant treatment.
4. No plans to change current antidepressant treatment.

Non-Medicated Depressed Participants' Inclusion Criteria

1. Age: 60-89 years
2. Diagnosis: Major depression, unipolar (by DSM-IV criteria);
3. Severity of depression: MADRS >or =15
4. No antidepressant treatment within the current episode. -

Exclusion Criteria:

1. 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];
2. High suicide risk, i.e. intent or plan to attempt suicide in near future;
3. 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);
4. History of psychiatric disorders other than unipolar major depression or generalized anxiety disorder (bipolar disorder, hypomania, and dysthymia are exclusion criteria);
5. 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;
6. Amnestic Mild Cognitive Impairment (a-MCI), or Multiple Domain Mild Cognitive Impairment (md-MCI);
7. 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;
8. Presence of a neurological brain disease and/or history of electroconvulsive therapy;
9. Current involvement in psychotherapy;
10. Inability to perform any of the ADLs (MAI: ADL subscale) even with assistance, e.g. walking with a cane is not an exclusion criterion;
11. Inability to speak English;
12. Aphasia;
13. Corrected visual acuity < 20/70; Color blindness -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Computer Treatment: Active; Computerized Cognitive Remediation: Targeted to underlying cerebral networks associated with remission.	Other: computerized cognitive remediation
Active Comparator: Computer Treatment: Control; Computerized Cognitive Remediation: Non-targeted	Other: computerized cognitive remediation:Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Montgomery-Asberg Depression Rating Scale	10 item measure to assess the core symptoms and cognitive features of clinical depression	4-6 weeks

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Investigators: Principal Investigator: Sarah Shizuko Morimoto, Psy.D., Weill Medical College of Cornell University

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Anticipated): July 1, 2017
• Study Completion (Anticipated): July 1, 2017

Study Registration Dates

• First Submitted: October 25, 2013
• First Submitted That Met QC Criteria: November 1, 2013
• First Posted (Estimate): November 8, 2013

Study Record Updates

• Last Update Posted (Estimate): February 3, 2017
• Last Update Submitted That Met QC Criteria: February 1, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Depression; Cognitive Remediation; Geriatric; Executive Dysfunction
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: K23MH095830 (U.S. NIH Grant/Contract)