Recruitment and Characterization of Healthy Research Volunteers for NIMH Intramural Studies

Healthy Volunteer Clinical Trial

Official title:

Recruitment and Characterization of Healthy Research Volunteers for NIMH Intramural Studies

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03304665
• Other study ID #: 170181
• Secondary ID: 17-M-0181
• Status: Active, not recruiting
• Start date: November 1, 2017
• Est. completion date: March 1, 2027

Study information

• Verified date: April 12, 2024
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Objective: To screen and create a list of adult volunteers in good health for participation in research studies conducted at the National Institutes of Health (NIH) in Bethesda, Maryland. Develop a normative set of structural and functional brain MRI scans that are linked to healthy research volunteer characteristics. Maximize scientific impact of data from volunteers by broadly sharing with other researchers.

Study Population: Adult males and females in general good health who are 18 years of age and older.

Design: Adult individuals who are interested in participating in NIMH IRP clinical studies as a healthy research volunteer can directly visit or be directed to visit the study website where they will first consent electronically and then complete a set of online self-report measures. Items may include: demographic information, mental health symptoms, disability status, substance use patterns, handedness and clinical/family history. Individuals who are flagged based on predetermined responses to survey items will be further screened by a member of the study clinical team. If found to be ineligible for the study because of a clinically significant or unstable medical or mental health condition, these individuals will be referred back to the community and/or given information about NIMH clinical studies for which they may be eligible. Respondents with no flags or who pass through additional screening will be scheduled for an in-person assessment. During the outpatient appointment and after in-person informed consent, participants will receive a brief clinical interview to screen for current medical and mental conditions, and risk for self-harm. They will complete assessments of psychological, emotional, physiologic, biological and cognitive functioning. Participants will undergo a physical exam and be asked to provide blood and urine samples for routine clinical labs as well as additional blood samples for future secondary analysis that could include genetic or biomarker assays. Participants can separately consent for an optional baseline brain magnetic resonance imaging (MRI) scan and an optional magnetoencephalography (MEG) exam. All consent forms will explicitly inform participants that if enrolled in the study, their de-identified data will be broadly and publicly shared through NIH-approved data repositories. Participants in this recruitment and characterization study will then be placed on a list of healthy research volunteers from which other NIMH IRP studies may recruit according to the inclusion and exclusion criteria in their respective IRB-approved protocols.

Outcome Measures: Outcome measures may include demographic data, mental and medical history and symptoms, results of psychological, emotional, physiologic, biological, and cognitive testing, physical exam and MRI findings.

...

Description:

Objective: To screen and create a list of adult volunteers in good health for participation in research studies conducted at the National Institutes of Health (NIH) in Bethesda, Maryland. Develop a normative set of structural and functional brain MRI scans that are linked to healthy research volunteer characteristics. Maximize scientific impact of data from volunteers by broadly sharing with other researchers.

Study Population: Adult males and females in general good health who are 18 years of age and older.

Design: Adult individuals who are interested in participating in NIMH IRP clinical studies as a healthy research volunteer can directly visit or be directed to visit the study website where they will first consent electronically and then complete a set of online self-report measures. Items may include: demographic information, mental health symptoms, disability status, substance use patterns, handedness and clinical/family history. Individuals who are flagged based on predetermined responses to survey items will be further screened by a member of the study clinical team. If found to be ineligible for the study because of a clinically significant or unstable medical or mental health condition, these individuals will be referred back to the community and/or given information about NIMH clinical studies for which they may be eligible. Respondents with no flags or who pass through additional screening will be scheduled for an in-person assessment. During the outpatient appointment and after in-person informed consent, participants will receive a brief clinical interview to screen for current medical and mental conditions, and risk for self-harm. They will complete assessments of psychological, emotional, physiologic, biological and cognitive functioning. Participants will undergo a physical exam and be asked to provide blood and urine samples for routine clinical labs as well as additional blood samples for future secondary analysis that could include genetic or biomarker assays. Participants can separately consent for an optional baseline brain magnetic resonance imaging (MRI) scan and an optional magnetoencephalography (MEG) exam. All consent forms will explicitly inform participants that if enrolled in the study, their de-identified data will be broadly and publicly shared through NIH-approved data repositories. Participants in this recruitment and characterization study will then be placed on a list of healthy research volunteers from which other NIMH IRP studies may recruit according to the inclusion and exclusion criteria in their respective IRB-approved protocols.

Outcome Measures: Outcome measures may include demographic data, mental and medical history and symptoms, results of psychological, emotional, physiologic, biological, and cognitive testing, physical exam and MRI findings.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 376
• Est. completion date: March 1, 2027
• Est. primary completion date: April 26, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

• INCLUSION CRITERIA:

1. 18 years of age and older.

2. Able to read, speak, and understand English.

3. Able to provide informed consent.

4. In current good general health.

EXCLUSION CRITERIA:

1. Have a history of significant or unstable medical or mental health condition requiring treatment, such as heart or lung disease, depression or psychosis.

2. Endorse current self-injury, suicidal thoughts or behavior.

3. Have current illicit drug use by history or urine drug screen.

4. Are found to have an abnormal physical exam or laboratory result that may require treatment or further evaluation.

5. Less than an 8th grade education or an IQ below 70.

6. Are a NIMH employee, staff member, or first degree relative (parent, sibling, child) of an NIMH employee or staff member.

Optional Brain MRI scan exclusion criteria:

1. Metal in body which would make having an MRI scan unsafe

2. Being uncomfortable in small closed spaces such as the MRI machine

3. Inability to lie comfortably on back for at least 45 minutes

4. Pregnancy

Optional MEG recording exclusion criteria:

1. Metal in body which would cause artifacts on MEG recordings.

Related Conditions & MeSH terms

• Healthy Volunteer

Locations

Country	Name	City	State
United States	National Institutes of Health Clinical Center	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Online self-report and in-person assessments that may yield demographic data, mental and medical history and symptoms, results of measures of psychological, emotional, physiologic, biological, and cognitive functioning, and physical or MRI findi...	Online self-report and in-person assessments that may yield demographic data, mental and medical history and symptoms, results of measures of psychological, emotional, physiologic, biological, and cognitive functioning, and physical or MRI findings.	Ongoing

External Links

•   NIH Clinical Center Detailed Web Page