NCT04631042

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,100

participants targeted

Target at P75+ for all trials

Timeline
68mo left

Started Sep 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress40%
Sep 2022Dec 2031

First Submitted

Initial submission to the registry

November 14, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 17, 2020

Completed
1.9 years until next milestone

Study Start

First participant enrolled

September 30, 2022

Completed
8.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2030

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2031

Last Updated

April 13, 2026

Status Verified

April 2, 2026

Enrollment Period

8.3 years

First QC Date

November 14, 2020

Last Update Submit

April 9, 2026

Conditions

Keywords

Neurodevelopmental disorderTwinNatural HistoryHeritabilityGlutamatedevelopmental trajectoryBrain Connectivity

Outcome Measures

Primary Outcomes (2)

  • Glutamate concentration measured using Magnetic Resonance Spectroscopy

    Age-related change in cortical glutamate levels and its moderation by individual differences in levels of impulsivity and compulsivity.

    Yearly if possible

  • Heritability of cortical glutamate (proportion of variance explained by additive genetic factors).

    Degree to which glutamate levels are under genetic control.

    Baseline

Secondary Outcomes (3)

  • Structural and functional connectivity

    Yearly if possible

  • Glutamate levels

    weeks to months

  • Differences in glutamate levels and other neurodevelopmental markers within twin pairs.

    Yearly if possible

Study Arms (1)

impulsive compulsive

Individuals between 6 and 80 years of age with a wide range of impulsivity/compulsivity behaviors - ranging from normal to mildly/extremely impaired.

Eligibility Criteria

Age6 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Individuals between 6 and 80 years of age with a wide range of impulsivity/compulsivity behaviors - ranging from normal to mildly/extremely impaired - will be recruited. No specific demographic groups will be targeted. Recruitment will be mainly done in the District of Columbia/Maryland/Virginia area, however some participants might travel from elsewhere.

You may qualify if:

  • In order to be eligible to participate in this study, an individual must meet all of the following criteria:
  • Stated willingness to comply with all study procedures and availability for the duration of the study.
  • Must be between 6 and 80 years of age.
  • Ability of participant to understand and the willingness to sign a written informed consent document.

You may not qualify if:

  • An individual who meets any of the following criteria will be excluded from participation in this study:
  • 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.)
  • Very premature birth (i.e., birth before 32 weeks of gestational age).
  • 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).
  • Psychotic disorders (including schizophrenia, psychosis not otherwise specified).
  • Dementia, or other conditions that, in the opinion of the investigators, would impede compliance or possibly hinder completion of the study.
  • Pregnant women.
  • Any other medical or psychiatric condition that in the opinion of the PI may confound study data/assessments.
  • \. 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 the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Publications (3)

  • Ziegler G, Hauser TU, Moutoussis M, Bullmore ET, Goodyer IM, Fonagy P, Jones PB; NSPN Consortium; Lindenberger U, Dolan RJ. Compulsivity and impulsivity traits linked to attenuated developmental frontostriatal myelination trajectories. Nat Neurosci. 2019 Jun;22(6):992-999. doi: 10.1038/s41593-019-0394-3. Epub 2019 May 13.

    PMID: 31086316BACKGROUND
  • Naaijen J, Lythgoe DJ, Amiri H, Buitelaar JK, Glennon JC. Fronto-striatal glutamatergic compounds in compulsive and impulsive syndromes: a review of magnetic resonance spectroscopy studies. Neurosci Biobehav Rev. 2015 May;52:74-88. doi: 10.1016/j.neubiorev.2015.02.009. Epub 2015 Feb 21.

    PMID: 25712432BACKGROUND
  • Fineberg NA, Chamberlain SR, Goudriaan AE, Stein DJ, Vanderschuren LJ, Gillan CM, Shekar S, Gorwood PA, Voon V, Morein-Zamir S, Denys D, Sahakian BJ, Moeller FG, Robbins TW, Potenza MN. New developments in human neurocognition: clinical, genetic, and brain imaging correlates of impulsivity and compulsivity. CNS Spectr. 2014 Feb;19(1):69-89. doi: 10.1017/S1092852913000801.

    PMID: 24512640BACKGROUND

Related Links

MeSH Terms

Conditions

Obsessive-Compulsive DisorderConduct DisorderAttention Deficit Disorder with HyperactivityAutism Spectrum DisorderNeurodevelopmental Disorders

Condition Hierarchy (Ancestors)

Anxiety DisordersMental DisordersAttention Deficit and Disruptive Behavior DisordersChild Development Disorders, Pervasive

Study Officials

  • Tonya J White, M.D.

    National Institute of Mental Health (NIMH)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tonya J White, M.D.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2020

First Posted

November 17, 2020

Study Start

September 30, 2022

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2031

Last Updated

April 13, 2026

Record last verified: 2026-04-02

Data Sharing

IPD Sharing
Will share

All de-identified medical information will be placed in a NIH repository (e.g., Biomedical Translational Research Information System (BTRIS)) in accordance to NIH policies. We will also share genomic and phenotypic data in controlled access databases such as dbGAP (database of Genotypes and Phenotypes). Other databases may be used as approved by NIH for the sharing of de-identified data.

Shared Documents
STUDY PROTOCOL
Time Frame
The timeline for data sharing will follow the NHGRI Genomic Data Sharing Policy. Currently data is deposited following IRB review once the study data collection is complete and the data has undergone quality control steps.
Access Criteria
Access requests for specific research purposes using NIH controlled-access data are reviewed by NIH Data Access Committees (DACs).

Locations