Translational Research Evaluating Neurocognitive Memory Processes

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Neurocognition Basal Ganglia Diseases Behavior Behavioral Symptoms Brain Diseases Central Nervous System Diseases Depression Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Duke Universtiy Medical Center

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Depressed Individuals

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

Inclusion criteria

Depressed Individuals Receiving ECT

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

Inclusion criteria

Individuals Diagnosed with PD

Male and female subjects, age 18-85
Diagnosed with PD
MMSE total score > 20
Graduate high school
Subject competent to provide informed consent

Exclusion criteria

Depressed Individuals/Depressed Individuals Receiving ECT

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

Exclusion criteria

Individuals Diagnosed with PD

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
Current diagnosis of dementia or delirium
Current visual, auditory, or motor impairment that compromises ability to take tests
Unable to read or comprehend English

Treatment and study plan

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

National Institute of Mental Health (NIMH)

Registry information

Acronym: TREC-MP

Important dates

Study start: 2013
Primary completion: 2015
Study completion: 2015
First posted: Apr 18, 2013
Registry last updated: Dec 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed