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Cognitive Training for Depression

NCT ID: NCT01936506

Last Updated: 2013-09-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2012-10-31

Brief Summary

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This study is evaluating the effects of two brain training exercises on: memory, cognitive processing and depression symptoms.

Detailed Description

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There is an urgent public health need to develop more effective and well tolerated treatments for patients with major depressive disorder (MDD); cognitive training interventions aiming to modify cognitive and affective processing abnormalities underlying MDD represent a promising new strategy. This research project translates a well established cognitive bias in major depressive disorder (MDD), working memory bias, into a novel intervention target. In a double-blind, randomized, controlled study, MDD participants undergo 4 weeks of cognitive training sessions, with two sessions per week.

Conditions

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Major Depressive Disorder

Keywords

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Cognitive training Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Cognitive Training A

emotional memory training exercise

Group Type EXPERIMENTAL

Cognitive Training A

Intervention Type BEHAVIORAL

Cognitive Training B

memory training exercise

Group Type ACTIVE_COMPARATOR

Cognitive Training B

Intervention Type BEHAVIORAL

Interventions

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Cognitive Training A

Intervention Type BEHAVIORAL

Cognitive Training B

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Primary, current Axis I diagnosis of Major Depressive Disorder according to DSM-IV criteria and Ham-D-17 score between 16-27
* Age 18-55
* Able to give informed consent

Exclusion Criteria

* A history of drug or alcohol abuse or dependence (DSM-IV criteria) within 6 months
* Visual impairment that would affect the ability to observe the computerized presentation of faces.
* Motor impairment that would affect the ability to provide a response by quickly pressing a button.
* Lifetime history of Bipolar spectrum disorders or schizophrenia spectrum disorders.
* Primary, current Axis I diagnosis other than Major Depressive Disorder
* Primary, current Axis II personality disorder.
* Currently attending a cognitive-behavioral psychotherapy regimen
* Acute suicidal or homicidal risk (evidenced by suicidal or homicidal attempt within 6 months of screening)
* Pregnancy in women.

Subjects must exhibit no or only moderate alcohol use. Subjects with current excessive use of alcohol (\> 8 ounces/day for men and \> 6 ounces/day for women) are ineligible for participation, as such drug use could confound the results.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Brian M Iacoviello, PhD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

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Icahn School of Medicine at Mount Sinai

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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GCO 10-0645

Identifier Type: -

Identifier Source: org_study_id