Translational Research Evaluating Neurocognitive Memory Processes

Neurocognition Clinical Trial

— TREC-MP  

Official title:

Translational Research Evaluating Neurocognitive Memory Processes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01834677
• Other study ID #: Pro00039288
• Secondary ID: 5K23MH087739-03
• Status: Completed
• Phase: N/A
• First received: April 16, 2013
• Last updated: December 1, 2015
• Start date: April 2013
• Est. completion date: November 2015

Study information

• Verified date: December 2015
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Neurocognition

Locations

Country	Name	City	State
United States	Duke Universtiy Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No