Cognitive Training for Depression

Major Depressive Disorder Clinical Trial

Official title:

Cognitive Training for Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01936506
• Other study ID #: GCO 10-0645
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: August 29, 2013
• Last updated: September 3, 2013
• Start date: July 2010
• Est. completion date: October 2012

Study information

• Verified date: September 2013
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Behavioral:
• Cognitive Training A

• Cognitive Training B

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in Hamilton Depression Rating Scale (Ham-D)	Change in depression symptom severity at week 4 compared as to baseline	baseline and week 4	No
Secondary	change in Self-referential Information Processing Task	change in Negative Affective Bias at week 4 as compared to baseline	baseline and week 4	No
Secondary	change in Working Memory	change in Neurocognition at week 4 as compared to baseline	baseline and week 4	No