Translational Research Evaluating Neurocognitive Memory Processes (TREC-MP)

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.

Study Overview

• Status: Completed
• Conditions: Neurocognition

• Study Type: Observational
• Enrollment (Actual): 76

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke Universtiy Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
California Verbal Learning Test-II	The California Verbal Learning Test-II (CVLT-II) is a standard neuropsychological instrument that assesses verbal learning and memory.	Baseline
California Verbal Learning Test-II	The California Verbal Learning Test-II (CVLT-II) is a standard neuropsychological instrument that assesses verbal learning and memory.	1-Month Follow-up

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Shawn McClintock, PhD, Duke University

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: April 16, 2013
• First Submitted That Met QC Criteria: April 16, 2013
• First Posted (Estimate): April 18, 2013

Study Record Updates

• Last Update Posted (Estimate): December 3, 2015
• Last Update Submitted That Met QC Criteria: December 1, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Depression; Parkinson's Disease; Neurocognition; Electroconvulsive Therapy (ECT)
• Other Study ID Numbers: Pro00039288; 5K23MH087739-03 (U.S. NIH Grant/Contract)