Clinical trial NCT01979289: Computerized Cognitive Remediation for Geriatric Depression
Official title: Computerized Cognitive Remediation for Geriatric Depression
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Major Depressive Disorder
Major Depressive Episode
Keywords: Executive Dysfunction
Cognitive Remediation
Geriatric
Depression
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2013-11-08
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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 -

Primary outcomes:
measure: Montgomery-Asberg Depression Rating Scale
timeFrame: 4-6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: White Plains
country: United States
facility: Weill Cornell Medical College
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Sarah Shizuko Morimoto, Psy.D.
role: PRINCIPAL_INVESTIGATOR
References: