Cognitive Training for Depression II

A Novel Cognitive Training Intervention for Major Depressive Disorder

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

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Behavioral: Cognitive Training A; Behavioral: Cognitive Training B

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 MDD, working memory bias, into a novel intervention target. In a double-blind, randomized, controlled study, MDD participants undergo 6 weeks of cognitive training sessions, with three sessions per week.

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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. Pregnant women are excluded from the study because research has shown that hormonal changes that occur during pregnancy can mimic and/or influence symptoms of depression. Including patterns of mood and cognition. These mood and cognitive changes could mask the effect of the cognitive training in this study, so pregnant women will be excluded for that reason.
• Enrolled participants can be currently taking medication but must be stabilized on their medication regimens before enrolling in the study (i.e., no medication has been started within 8 weeks, stopped within 6 weeks or titrated up or down within 4 weeks of study entry). Accordingly, if a patient's medication status must change during the course of the study, we will discontinue them in the study. We do not anticipate that this will occur frequently, as again, patients' medication regimens must be stable before enrolling in the study. No medications will be discontinued for the purpose of enrollment into the study.

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cognitive Training A; emotional memory training exercise	Behavioral: Cognitive Training A
Active Comparator: Cognitive Training B; memory training exercise	Behavioral: Cognitive Training B

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hamilton Depression Rating Scale (Ham-D)	Depression symptom severity comparison at week 6 to baseline	baseline and week 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Negative Affective Bias	scale using Self-referential Information Processing Task; Affective Go/No-Go; Emotional Stroop	baseline
Negative Affective Bias	scale using Self-referential Information Processing Task; Affective Go/No-Go; Emotional Stroop	week 3
Negative Affective Bias	scale using Self-referential Information Processing Task; Affective Go/No-Go; Emotional Stroop	week 6
Working Memory	Neurocognition	baseline
Working Memory	Neurocognition	week 3
Working Memory	Neurocognition	week 6

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Brian M Iacoviello, PhD, Icahn School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): May 16, 2017
• Study Completion (Actual): May 16, 2017

Study Registration Dates

• First Submitted: August 29, 2013
• First Submitted That Met QC Criteria: August 29, 2013
• First Posted (Estimate): September 4, 2013

Study Record Updates

• Last Update Posted (Actual): July 21, 2017
• Last Update Submitted That Met QC Criteria: July 19, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Depression; Cognitive training
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: GCO 12-0266; 1K23MH099223-01 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No