Cognitive Training for Depression II

Major Depressive Disorder Clinical Trial

Official title:

A Novel Cognitive Training Intervention for Major Depressive Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01934491
• Other study ID #: GCO 12-0266
• Secondary ID: 1K23MH099223-01
• Status: Completed
• Phase: N/A
• First received: August 29, 2013
• Last updated: July 19, 2017
• Start date: August 2013
• Est. completion date: May 16, 2017

Study information

• Verified date: July 2017
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: May 16, 2017
• Est. primary completion date: May 16, 2017
• Accepts healthy volunteers: No
• Gender: All
• 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. 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.

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 (2)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hamilton Depression Rating Scale (Ham-D)	Depression symptom severity comparison at week 6 to baseline	baseline and week 6
Secondary	Negative Affective Bias	scale using Self-referential Information Processing Task; Affective Go/No-Go; Emotional Stroop	baseline
Secondary	Negative Affective Bias	scale using Self-referential Information Processing Task; Affective Go/No-Go; Emotional Stroop	week 3
Secondary	Negative Affective Bias	scale using Self-referential Information Processing Task; Affective Go/No-Go; Emotional Stroop	week 6
Secondary	Working Memory	Neurocognition	baseline
Secondary	Working Memory	Neurocognition	week 3
Secondary	Working Memory	Neurocognition	week 6