Cognitive Training for Depression
1 other identifier
interventional
21
1 country
1
Brief Summary
This study is evaluating the effects of two brain training exercises on: memory, cognitive processing and depression symptoms.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 major-depressive-disorder
Started Jul 2010
Typical duration for phase_1 major-depressive-disorder
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedFirst Submitted
Initial submission to the registry
August 29, 2013
CompletedFirst Posted
Study publicly available on registry
September 6, 2013
CompletedSeptember 6, 2013
September 1, 2013
2.3 years
August 29, 2013
September 3, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
change in Hamilton Depression Rating Scale (Ham-D)
Change in depression symptom severity at week 4 compared as to baseline
baseline and week 4
Secondary Outcomes (2)
change in Self-referential Information Processing Task
baseline and week 4
change in Working Memory
baseline and week 4
Study Arms (2)
Cognitive Training A
EXPERIMENTALemotional memory training exercise
Cognitive Training B
ACTIVE COMPARATORmemory training exercise
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Brian M Iacoviello, PhD
Icahn School of Medicine at Mount Sinai
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 29, 2013
First Posted
September 6, 2013
Study Start
July 1, 2010
Primary Completion
October 1, 2012
Study Completion
October 1, 2012
Last Updated
September 6, 2013
Record last verified: 2013-09