Major Depressive Disorder
Conditions
Keywords
Cognitive training, Depression
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.
Interventions
BEHAVIORALCognitive Training A
BEHAVIORALCognitive Training B
Sponsors
Icahn School of Medicine at Mount Sinai
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in Hamilton Depression Rating Scale (Ham-D) | baseline and week 4 | Change in depression symptom severity at week 4 compared as to baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change in Self-referential Information Processing Task | baseline and week 4 | change in Negative Affective Bias at week 4 as compared to baseline |
| change in Working Memory | baseline and week 4 | change in Neurocognition at week 4 as compared to baseline |
Countries
United States
Outcome results
None listed