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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
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Duke University

Brief Summary:

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
Neurocognition

Study Type : Observational
Actual Enrollment : 76 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory

Group/Cohort
Healthy Human
Depressed Human
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



Primary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects are able to contact the study team. The depressed ECT cohort will be referred to study team.
Criteria

Inclusion Criteria:Depressed Individuals

  1. Male and female subjects, age 18-85
  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

Inclusion Criteria:Depressed Individuals Receiving ECT

  1. Same as for Depressed Cohort Inclusion Criteria (see above)
  2. Referred for ECT
  3. Subject competent to provide informed consent

Inclusion Criteria:Individuals Diagnosed with PD

  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:Depressed Individuals/Depressed Individuals Receiving ECT

  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
  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

Exclusion Criteria:Individuals Diagnosed with PD

  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

Information from the National Library of Medicine

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


Locations
United States, North Carolina
Duke Universtiy Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Shawn McClintock, PhD Duke University

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01834677     History of Changes
Other Study ID Numbers: Pro00039288
5K23MH087739-03 ( U.S. NIH Grant/Contract )
First Posted: April 18, 2013    Key Record Dates
Last Update Posted: December 3, 2015
Last Verified: December 2015

Keywords provided by Duke University:
Depression
Neurocognition
Electroconvulsive Therapy (ECT)
Parkinson's Disease