Cognitive Training for Depression

Phase 1

Completed

• Conditions: Major Depressive Disorder

• Registration Number: NCT01936506
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2010-07
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Study First Submitted: 2013-08-29
• Status Verified: 2013-09
• Study First Submitted QC: 2013-09-03
• Last Update Submitted: 2013-09-03
• Study First Posted: 2013-09-06
• Last Update Posted: 2013-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
change in Hamilton Depression Rating Scale (Ham-D)	baseline and week 4	Change in depression symptom severity at week 4 compared as to baseline

Secondary Outcome Measures

Name	Time	Method
change in Self-referential Information Processing Task	baseline and week 4	change in Negative Affective Bias at week 4 as compared to baseline
change in Working Memory	baseline and week 4	change in Neurocognition at week 4 as compared to baseline

Trial Locations

Locations (1)

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States