NCT04631042 Developing Brain, Impulsivity and Compulsivity
| NCT ID | NCT04631042 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Institute of Mental Health (NIMH) |
| Condition | Typical Development |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,100 participants |
| Start Date | 2022-09-30 |
| Primary Completion | 2030-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,100 participants in total. It began in 2022-09-30 with a primary completion date of 2030-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Background: Impulsivity is acting 'without thinking.' Compulsivity is being overly inflexible. People vary in how impulsive or compulsive they are. Extreme versions of these behaviors play a role in mental disorders. Researchers want to study changes in the brain to learn more about these behaviors. Differences in genes may also play a role. Objective: To learn about genetic \& brain features that explain why levels of impulsivity and compulsivity vary across people. Eligibility: People ages 6 - 80 Design: Participants will be screened with a medical history and medical record review. Participants will talk about their mental and behavioral development. They may discuss topics like drug use and sexual activity. They will complete surveys about their compulsivity and impulsivity. Parents of child participants may also complete these surveys. Participants may take memory, attention, and thinking tests. They may give blood or saliva samples for gene studies and they may give blood to make induced pluripotent stem cells. Participants may have their face and irises photographs taken. Participants may have a magnetic resonance imaging scan. It will take pictures of their brain. The scanner is shaped like a cylinder. Participants will lie on a table that slides in and out of the scanner. A coil will be placed over their head. They will lie still, watch a movie, and play a game. Participants may ask family members to join the study. Researchers are particularly interested in recruiting twin pairs to the study. Participants under age 25 may repeat these tests every 1-2 years until they turn 25 or until the study ends. For those over age 25, participation will last less than 1 month.
Eligibility Criteria
* INCLUSION CRITERIA: In order to be eligible to participate in this study, an individual must meet all of the following criteria: 1. Stated willingness to comply with all study procedures and availability for the duration of the study. 2. Must be between 6 and 80 years of age. 3. Ability of participant to understand and the willingness to sign a written informed consent document. EXCLUSION CRITERIA: An individual who meets any of the following criteria will be excluded from participation in this study: 1. Cognitively not capable of performing study procedures or lack of capacity to provide informed consent. Indications of a lack of cognitive capacity could include a known full-scale IQ under 70, or a history from the screening interview that implies global intellectual disabilities (e.g., placement in a school for children with intellectual disability etc.) 2. Very premature birth (i.e., birth before 32 weeks of gestational age). 3. Any known brain abnormalities (e.g., tumor, periventricular leukomalacia, microcephaly) or history of medical conditions known to affect cerebral anatomy (e.g., epilepsy, history of stroke, head injury with a loss of consciousness of one hour or more). 4. Psychotic disorders (including schizophrenia, psychosis not otherwise specified). 5. Dementia, or other conditions that, in the opinion of the investigators, would impede compliance or possibly hinder completion of the study. 6. Pregnant women. 7. Any other medical or psychiatric condition that in the opinion of the PI may confound study data/assessments. Additional exclusion criteria for optional MRI procedure: 1\. Individuals who are not able to receive an MRI (e.g., metal bioimplants, claustrophobia, inability to lie flat on their backs, pregnant women, and any other contraindications for MRI scanning according to the NMR Center MRI safety guidelines).
Contact & Investigator
Tonya J White, M.D.
PRINCIPAL INVESTIGATOR
National Institute of Mental Health (NIMH)
Frequently Asked Questions
Who can join the NCT04631042 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 80 Years, studying Typical Development. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04631042 currently recruiting?
Yes, NCT04631042 is actively recruiting participants. Contact the research team at tonya.white@nih.gov for enrollment information.
Where is the NCT04631042 trial being conducted?
This trial is being conducted at Bethesda, United States.
Who is sponsoring the NCT04631042 clinical trial?
NCT04631042 is sponsored by National Institute of Mental Health (NIMH). The principal investigator is Tonya J White, M.D. at National Institute of Mental Health (NIMH). The trial plans to enroll 1,100 participants.