Major Depressive DisorderNCT01979289

Computerized Cognitive Remediation for Geriatric Depression

A study testing computerized cognitive remediation in people with Major Depressive Disorder and Major Depressive Episode, run by Weill Medical College of Cornell University at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 60 to 89 years
Conditions the study is for: Major Depressive Disorder, Major Depressive Episode
What is being tested?: computerized cognitive remediation
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteUnited States
Study dates: Aug 2012to Jul 2017
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 60 to 89 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

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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. -

Who cannot join

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);

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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 -

Trial locations and contacts

1 site in 1 country.

Maria Coluccio, M.A. contact

914-997-4327

Institute of Geriatric Psychiatry contact

914-997-4331

United States1 site, 1 recruiting

Weill Cornell Medical College
White Plains, New York, 10605
Sarah Shizuko Morimoto, Psy.D.
Recruiting

Other trials in United States

About this study

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.

Conditions: Major Depressive Disorder, Major Depressive Episode
Being tested: computerized cognitive remediation, computerized cognitive remediation:Control
Keywords: Executive Dysfunction, Cognitive Remediation, Geriatric, Depression
Medical subject headings: Depressive Disorder, Major, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

computerized cognitive remediationOther
computerized cognitive remediation:ControlOther

Study groups in NCT01979289
Study group	Role	What they receive
Computer Treatment: Active	Experimental	Computerized Cognitive Remediation: Targeted to underlying cerebral networks associated with remission. Receives: Other: computerized cognitive remediation
Computer Treatment: Control	Active comparator	Computerized Cognitive Remediation: Non-targeted Receives: Other: computerized cognitive remediation:Control

What is being measured

The primary outcome is the main question the study is designed to answer.

Montgomery-Asberg Depression Rating Scale
10 item measure to assess the core symptoms and cognitive features of clinical depression
Measured: 4-6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2012Jul 2017

First posted8 Nov 2013 (estimated)
Study startAug 2012
Primary completionJul 2017 (estimated)
Study completionJul 2017 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 60 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01979289
Sponsor's protocol ID: K23MH095830
Status last verified: Feb 2017
First submitted: 25 Oct 2013
Last updated: 3 Feb 2017
Results posted: No
Data monitoring committee: Yes

Want to know more?

Maria Coluccio, M.A.

914-997-4327

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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A Study to Evaluate the Safety and Efficacy of ALKS 7290 as an Adjunctive Therapy to Antidepressants in Adult Participants With Major Depressive Disorder
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All Major Depressive Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Computerized Cognitive Remediation for Geriatric Depression
ClinicalTrials.gov ID: NCT01979289
Acronym / sponsor ID: K23MH095830
Conditions: Major Depressive Disorder, Major Depressive Episode
Keywords: Executive Dysfunction, Cognitive Remediation, Geriatric, Depression
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 60 participants (estimated)
Lead sponsor: Weill Medical College of Cornell UniversityUniversity, hospital or other
Study start: Aug 2012
Primary completion: Jul 2017 (estimated)
Study completion: Jul 2017 (estimated)
First posted: 8 Nov 2013 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Computer Treatment: Active	Experimental	Other: computerized cognitive remediationComputerized Cognitive Remediation: Targeted to underlying cerebral networks associated with remission.
Computer Treatment: Control	Active comparator	Other: computerized cognitive remediation:ControlComputerized Cognitive Remediation: Non-targeted

Who may qualify

Ages: 60 to 89 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

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.

Key exclusion criteria (13 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
computerized cognitive remediation	Other	Computer Treatment: Active
computerized cognitive remediation:Control	Other	Computer Treatment: Control

Primary outcome

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

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2017.

Related trials for Major Depressive Disorder

RecruitingPhase 2
Double-blind, Placebo-controlled Study in Adults With Major Depressive Disorder
Major Depressive Disorder (MDD)
RecruitingPhase 2
A Study to Evaluate the Safety and Efficacy of ALKS 7290 as an Adjunctive Therapy to Antidepressants in Adult Participants With Major Depressive Disorder
Major Depressive Disorder (MDD)
Recruiting
rTMS to Target Neural Connectivity and Rumination in Treatment-Resistant Depression
Depression, Treatment Resistant
Recruiting
Digital Intervention for Physical Activity
Depression - Major Depressive Disorder, Anxiety
Recruiting
Ketogenic Diet and Neuromodulation in Treatment Resistant Depression
Major Depressive Disorder (MDD), Treatment Resistant Depression (TRD)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Maria Coluccio, M.A. contact

914-997-4327

Institute of Geriatric Psychiatry contact

914-997-4331

Sarah Shizuko Morimoto, Psy.D. principal investigator

Weill Medical College of Cornell University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 3 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Maria Coluccio, M.A. (914-997-4327), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Montgomery-Asberg Depression Rating Scale (time frame: 4-6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01979289.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2017.