Translational Research Evaluating Neurocognitive Memory Processes
NCT ID: NCT01834677
Last Updated: 2015-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
76 participants
OBSERVATIONAL
2013-04-30
2015-11-30
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Healthy Human
No interventions assigned to this group
Depressed Human
No interventions assigned to this group
Depressed Human, Undergoing Electroconvulsive Therapy
Electroconvulsive Therapy is being received as standard of care, not as a study intervention.
No interventions assigned to this group
Human Diagnosed with Parkinson's Disease
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. DSM-IV-TR diagnosis of major depressive episode, unipolar, confirmed by the MINI-PLUS \[221\]
3. HRSD24 total score \> 10
4. MMSE total score \> 26
5. Graduated from high school
6. Competent to provide informed consent
2. Referred for ECT
3. Subject competent to provide informed consent
1. Male and female subjects, age 18-85
2. Diagnosed with PD
3. MMSE total score \> 20
4. Graduate high school
5. Subject competent to provide informed consent
Exclusion Criteria
2. Current neurostimulation treatment (e.g., ECT, MST, rTMS, vagus nerve stimulation, deep brain stimulation)
3. Current alcohol abuse or dependence within past 12 months
4. Current substance abuse or dependence within past 12 months
5. Lifetime mental retardation
6. History of central nervous system (CNS) disease
7. Current diagnosis of dementia or delirium
8. Current visual, auditory, or motor impairment that compromises ability to take tests
9. Unable to read or comprehend English
1. Lifetime history of bipolar disorder, schizophrenia, schizoaffective disorder, or mental retardation
2. Current neurostimulation treatment (e.g., ECT, MST, rTMS, vagus nerve stimulation, deep brain stimulation)
3. Current alcohol abuse or dependence within past 12 months
4. Current substance abuse or dependence within past 12 months
5. Lifetime mental retardation
6. History of central nervous system (CNS) disease other than Parkinson's Disease
7. Current diagnosis of dementia or delirium
8. Current visual, auditory, or motor impairment that compromises ability to take tests
9. Unable to read or comprehend English
18 Years
85 Years
ALL
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
Duke University
OTHER
Responsible Party
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Principal Investigators
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Shawn McClintock, PhD
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
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Duke Universtiy Medical Center
Durham, North Carolina, United States
Countries
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Other Identifiers
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Pro00039288
Identifier Type: -
Identifier Source: org_study_id