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Clinical Trials/NCT01936506
NCT01936506
Completed
Phase 1

Cognitive Training for Depression

Icahn School of Medicine at Mount Sinai1 site in 1 country21 target enrollmentJuly 2010

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Major Depressive Disorder
Sponsor
Icahn School of Medicine at Mount Sinai
Enrollment
21
Locations
1
Primary Endpoint
change in Hamilton Depression Rating Scale (Ham-D)
Status
Completed
Last Updated
12 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2010
End Date
October 2012
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

change in Hamilton Depression Rating Scale (Ham-D)

Time Frame: baseline and week 4

Change in depression symptom severity at week 4 compared as to baseline

Secondary Outcomes

  • change in Self-referential Information Processing Task(baseline and week 4)
  • change in Working Memory(baseline and week 4)

Study Sites (1)

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