Major Depressive Disorder Clinical Trial
Official title:
A Novel Cognitive Training Intervention for Major Depressive Disorder
Verified date | July 2017 |
Source | Icahn School of Medicine at Mount Sinai |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study is evaluating the effects of two brain training exercises on: memory, cognitive processing and depression symptoms.
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. |
Country | Name | City | State |
---|---|---|---|
United States | Icahn School of Medicine at Mount Sinai | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Icahn School of Medicine at Mount Sinai | National Institute of Mental Health (NIMH) |
United States,
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 |
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