Computerized Cognitive Remediation for Geriatric Depression

Major Depressive Disorder Clinical Trial

Official title:

Computerized Cognitive Remediation for Geriatric Depression

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01979289
• Other study ID #: K23MH095830
• Status: Recruiting
• Phase: N/A
• First received: October 25, 2013
• Last updated: February 1, 2017
• Start date: August 2012
• Est. completion date: July 2017

Study information

• Verified date: February 2017
• Source: Weill Medical College of Cornell University
• Contact: Maria Coluccio, M.A.
• Phone: 914-997-4327
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 89 Years

Eligibility

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 -

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder
• Major Depressive Episode

Intervention

Other:
• computerized cognitive remediation

• computerized cognitive remediation:Control

Locations

Country	Name	City	State
United States	Weill Cornell Medical College	White Plains	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Montgomery-Asberg Depression Rating Scale	10 item measure to assess the core symptoms and cognitive features of clinical depression	4-6 weeks