Translational Research Evaluating Neurocognitive Memory Processes

NCT01834677 | Completed

• 2 other identifiers: Pro000392885K23MH087739-03
• Study Type: observational
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Neurocognition

Keywords

Depression; Neurocognition; Electroconvulsive Therapy (ECT); Parkinson's Disease

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (4)

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

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Male and female subjects, age 18-85
• DSM-IV-TR diagnosis of major depressive episode, unipolar, confirmed by the MINI-PLUS \[221\]
• HRSD24 total score \> 10
• MMSE total score \> 26
• Graduated from high school
• Competent to provide informed consent
• Referred for ECT
• Subject competent to provide informed consent
• Male and female subjects, age 18-85
• Diagnosed with PD
• MMSE total score \> 20
• Graduate high school
• Subject competent to provide informed consent

You may not qualify if:

• Lifetime history of bipolar disorder, schizophrenia, schizoaffective disorder, or mental retardation
• Current neurostimulation treatment (e.g., ECT, MST, rTMS, vagus nerve stimulation, deep brain stimulation)
• Current alcohol abuse or dependence within past 12 months
• Current substance abuse or dependence within past 12 months
• Lifetime mental retardation
• History of central nervous system (CNS) disease
• Current diagnosis of dementia or delirium
• Current visual, auditory, or motor impairment that compromises ability to take tests
• Unable to read or comprehend English
• Lifetime history of bipolar disorder, schizophrenia, schizoaffective disorder, or mental retardation
• Current neurostimulation treatment (e.g., ECT, MST, rTMS, vagus nerve stimulation, deep brain stimulation)
• Current alcohol abuse or dependence within past 12 months
• Current substance abuse or dependence within past 12 months
• Lifetime mental retardation
• History of central nervous system (CNS) disease other than Parkinson's Disease

Sponsors & Collaborators

• Duke University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Duke Universtiy Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Depression; Parkinson Disease

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Shawn McClintock, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2013
• First Posted: April 18, 2013
• Study Start: April 1, 2013
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: December 3, 2015

Record last verified: 2015-12

Locations

US (1)