NeurocognitionTREC-MPNCT01834677
Translational Research Evaluating Neurocognitive Memory Processes
An observational study of Neurocognition, run by Duke University at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Neurocognition
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Nov 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects are able to contact the study team. The depressed ECT cohort will be referred to study team.
Who may be able to join
- 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
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- Same as for Depressed Cohort Inclusion Criteria (see above)
- 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
- 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
Who cannot join
- 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
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- Current diagnosis of dementia or delirium
- Current visual, auditory, or motor impairment that compromises ability to take tests
- Unable to read or comprehend English
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Universtiy Medical Center
Durham, North Carolina, 27710
About this study
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
- Medical subject headings
- Depression, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Human | Not described | |
| Depressed Human | Not described | |
| 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 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
California Verbal Learning Test-II
The California Verbal Learning Test-II (CVLT-II) is a standard neuropsychological instrument that assesses verbal learning and memory.
Measured: 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.
Measured: 1-Month Follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeurocognitionStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Shawn McClintock, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01834677
- Sponsor's protocol ID
- Pro00039288
- Other IDs
- 5K23MH087739-03
- Acronym
- TREC-MP
- Status last verified
- Dec 2015
- First submitted
- 16 Apr 2013
- Last updated
- 3 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translational Research Evaluating Neurocognitive Memory Processes
- ClinicalTrials.gov ID
- NCT01834677
- Acronym / sponsor ID
- TREC-MP / Pro00039288
- Conditions
- Neurocognition
- Keywords
- Depression, Neurocognition, Electroconvulsive Therapy (ECT), Parkinson's Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Apr 2013
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 18 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 | – | – |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects are able to contact the study team. The depressed ECT cohort will be referred to study team.
Key inclusion criteria (24 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shawn McClintock, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurocognition, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
California Verbal Learning Test-II (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2015.