Clinical trial NCT01934491: Cognitive Training for Depression II
Official title: A Novel Cognitive Training Intervention for Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Keywords: Cognitive training
Depression
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2013-09-04
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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. 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.

Primary outcomes:
measure: Hamilton Depression Rating Scale (Ham-D)
timeFrame: baseline and week 6
Secondary outcomes:
measure: Negative Affective Bias
timeFrame: baseline
measure: Negative Affective Bias
timeFrame: week 3
measure: Negative Affective Bias
timeFrame: week 6
measure: Working Memory
timeFrame: baseline
measure: Working Memory
timeFrame: week 3
measure: Working Memory
timeFrame: week 6
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Brian M Iacoviello, PhD
role: PRINCIPAL_INVESTIGATOR
References: