Translational Research Evaluating Neurocognitive Memory Processes (TREC-MP)
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|ClinicalTrials.gov Identifier: NCT01834677|
Recruitment Status : Completed
First Posted : April 18, 2013
Last Update Posted : December 3, 2015
The purpose of this study is to evaluate the psychometric properties and utility of new, computerized, neurocognitive measures in humans with depression, and humans with depression undergoing electroconvulsive therapy (ECT). The benefits of the study outweigh the risk as there is the possibility of developing better computerized neurocognitive measures, and the risks are limited to no more than minimal test related fatigue and psychological stress.
Depressed humans, depressed human participants undergoing ECT, and humans diagnosed with Parkinson's disease (age 18-85) will be invited to participate in this study. After providing informed consent participants will undergo a clinical psychiatric evaluation to confirm the inclusion/exclusion criteria. After the clinical psychiatric evaluation, participants will complete common and new neurocognitive measures. There will be a total of two testing visits (baseline, 1-month follow-up). The anticipated duration of the participant's involvement is no more than 2 study visits that can take place over a 4-day period (i.e., the clinical evaluation can occur on day 1 and the neuropsychological measures can be administered on day 2 of each study visit) equating to approximately 6-hours (3-hours each day) per study visit.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||76 participants|
|Official Title:||Translational Research Evaluating Neurocognitive Memory Processes|
|Study Start Date :||April 2013|
|Actual Primary Completion Date :||November 2015|
|Actual Study Completion Date :||November 2015|
Depressed Human, Undergoing Electroconvulsive Therapy
Electroconvulsive Therapy is being received as standard of care, not as a study intervention.
|Human Diagnosed with Parkinson's Disease|
- California Verbal Learning Test-II [ Time Frame: Baseline ]The California Verbal Learning Test-II (CVLT-II) is a standard neuropsychological instrument that assesses verbal learning and memory.
- California Verbal Learning Test-II [ Time Frame: 1-Month Follow-up ]The California Verbal Learning Test-II (CVLT-II) is a standard neuropsychological instrument that assesses verbal learning and memory.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01834677
|United States, North Carolina|
|Duke Universtiy Medical Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Shawn McClintock, PhD||Duke University|