ClinicalTrials.gg
RecruitingNCT04631042Updated Sep 25, 2026

Developing Brain, Impulsivity and Compulsivity

An observational study in Typical Development, Obsessive Compulsive Disorder and Conduct Disorder, sponsored by National Institute of Mental Health (NIMH). Recruiting at 1 site in United States. Open to participants aged 6 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-25.

Sponsored by National Institute of Mental Health (NIMH) · Observational

From the registry’s dates

  • Started Sep 2022; still recruiting 4 years 1 month later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,100
Ages
6 Years to 80 Years
Sex
All
01

Study 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.

Read the detailed description

Study Description:

Many neuropsychiatric disorders have extreme impairing impulsivity and compulsivity behaviors at their core. We hypothesized that the development of symptoms of impulsivity and compulsivity during childhood/adolescence and early adulthood will be associated with atypical trajectories of brain features including cortical glutamate (the main excitatory neurotransmitter) and functional/structural brain connectivity. Additionally, we hypothesize that cortical glutamate will be under genetic control (i.e., heritable) and that common genetic variant risk for disorders characterized by extreme impulsivity (e.g., attention deficit hyperactivity disorder) and by extreme compulsivity (e.g., obsessive compulsive disorder, autism spectrum disorder) will also be associated with atypical cortical glutamate trajectories. To elucidate the relationships between the developing brain, compulsivity/impulsivity and genomics, we will collect clinical assessments including clinician-led interviews, neurobehavioral assessments, neuroimaging data, and genomic samples using 1) a prospective longitudinal design to answer developmental hypotheses; 2) a twin design to assess heritability hypotheses.

Objectives:

Primary Objective:

A) To assess the effects of impulsivity and compulsivity on the developmental trajectories of cortical glutamate.

B) To determine the heritability of cortical glutamate.

Secondary Objectives:

A) To establish the reliability of glutamate measurements.

B) To examine the impact of atypical glutamate levels on developing structural and functional connections within the fronto-striatal circuits.

C) To assess within twin pair differences in neurodevelopmental markers (cortical glutamate, structural/functional MRI) in relation to differences in symptom domains.

Endpoints:

Primary Endpoint:

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

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

Secondary Endpoints:

A) 1) Glutamate levels estimated at 3 Tesla at short intervals to establish test-retest reliability.

2) Glutamate levels estimated at both 3 Tesla and 7 Tesla (cross scanner validation).

B) Measures of the brain's structural and functional connectivity.

C) Within twin-pair differences in neurodevelopmental markers symptom domains (impulsivity/compulsivity).

02

Conditions studied

  • Typical Development
  • Obsessive Compulsive Disorder
  • Conduct Disorder
  • Attention Deficit Hyperactivity Disorder
  • Autism Spectrum Disorder

Keywords

  • Neurodevelopmental disorder
  • Twin
  • Natural History
  • Heritability
  • Glutamate
  • developmental trajectory
  • Brain Connectivity
03

In context

Obsessive-Compulsive Disorder

635 studies on the registry are indexed under Obsessive-Compulsive Disorder; 166 are open to participants now.

This study's planned enrollment of 1,100 is above the median of 133 across 86 observational studies indexed under Obsessive-Compulsive Disorder.

Browse Obsessive-Compulsive Disorder studies →

Lead sponsor

National Institute of Mental Health (NIMH) is the lead sponsor of 367 studies on the registry; 45 are open to participants now.

Of its 25 completed or terminated interventional studies of FDA-regulated products, 24 (96%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 document.

Exclusion criteria

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 . 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 for MRI scanning according to the NMR Center MRI safety guidelines).

Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,100 participants (estimated)

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Yearly if possible

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

    Degree to which glutamate levels are under genetic control.

    Time frame: Baseline

Secondary outcomes

  1. Structural and functional connectivity

    Structural and functional connectivity measured throughout development using Magnetic Resonance Imaging.

    Time frame: Yearly if possible

  2. Glutamate levels

    Glutamate measurement at 7 Tesla is now the gold standard for glutamate measurements, against which we will compare measurements at 3 Tesla.

    Time frame: weeks to months

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

    Differences in twin characteristics will be measured through clinical symptom assessment, biomarkers, Magnetic Resonance Imaging, neuropsychological testing, and questionnaires.

    Time frame: Yearly if possible

07

Study locations

1 of 1 sites recruiting
  • National Institutes of Health Clinical Center
    Bethesda, Maryland 20892, United States
    Recruiting
    • For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) · Contactprpl@cc.nih.gov · 800-411-1222
08

References and documents

Publications

  • 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. PubMed 31086316 ↗
  • 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. PubMed 25712432 ↗
  • 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. PubMed 24512640 ↗

Individual participant data

Plan to share: Yes — 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.

Supporting information: 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).

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2022 (actual). Primary completion is estimated for Dec 2030, 99 months after the start.

Of 27 observational studies under Obsessive-Compulsive Disorder, half reached primary completion within 68 months of starting (the median), counting those still running; a quarter within 41 and three quarters within 84. This study's planned 99 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 14, 2020
First posted
Nov 17, 2020
StartActual
Sep 30, 2022
Primary completionEst.
Dec 31, 2030
CompletionEst.
Dec 31, 2031
Last update
Sep 25, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Minor edits
Nothing that changes what the study is or who can join. Edited: verification date
1 update, last Sep 25, 2026
Show all 1 update
  1. Sep 25, 2026
    Minor edits only
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT04631042
Responsible party
Sponsor
First posted
Nov 17, 2020
Start date
Sep 30, 2022
Primary completion
Dec 31, 2030 (estimated)
Completion
Dec 31, 2031 (estimated)
Last update
Sep 25, 2026

Study contacts

Tonya J White, M.D.
Contact
tonya.white@nih.gov
(301) 496-5192
Tonya J White, M.D.
principal investigator · National Institute of Mental Health (NIMH)

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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