Recruiting

Observational Study

Sponsor:

National Institute of Mental Health (NIMH)

Code:

NCT00271622

Conditions

Neurologic Disorders

Autism

Neurodegenerative Disease

Neurobehavioral Manifestation

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Study Details

Brief summary:

The purpose of this protocol is to allow for the careful evaluation of healthy volunteers and individuals with risk for psychiatric disorders or neurodevelopmental disorders, such as autism spectrum disorder for specific protocols at NIH.

Conditions

Neurologic Disorders

Autism

Neurodegenerative Disease

Neurobehavioral Manifestation

Study ID

NCT00271622

Start date

Feb 27, 2006

Status verified date

Jun 23, 2026

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

  • INCLUSION CRITERIA:
  • Subjects must be at least 6 weeks of age.
  • Subjects or their parents must be competent to comprehend the purpose of the screening process and to provide written informed consent. Parents/guardians will sign the consent form, and both minors and adults (depending on results of capacity assessment) will be asked to assent only if it is determined that they understand their role in the study.
  • Subjects must be willing to undergo an evaluation which may include a psychiatric interview; and medical, neurological, and laboratory examinations (as appropriate, such as renal and liver function tests, serum electrolytes, urinalysis, blood levels of psychotropic drugs, and urine drug screen for the presence of psychoactive drugs and drugs of abuse, as determined on a subject-to-subject basis).

EXCLUSION CRITERIA:

-Lack of appropriate consent: For minor patients, consent must be obtained from all legal guardians/caretakers, including both parents in separated or divorced families where there is shared legal custody of the child. In such cases, both parents must consent to the child s participation in this protocol.

Study Design

Enrollment

5000 participants

Anticipated

Interventions and Outcome Measures

Arms

healthy volunteers

healthy volunteers

individuals at risk

individuals with risk for psychiatric disorders or neurodevelopmental disorders, such as autism spectrum disorders.

Primary outcome measure

  • Screening evaluations such as a psychiatric interview; a diagnostic interview; developmental and/or cognitive testing; ratings of other psychiatric symptoms [ Time Frame: Ongoing ]

Central Contacts and Locations

Central contacts

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)

800-411-1222ccopr@nih.gov

More Information

Sponsor

National Institute of Mental Health (NIMH)

Last update posted

Aug 24, 2026

Last verified

Jun 23, 2026

Keywords

  • Developmental Delay
  • Pediatric
  • Pervasive Developmental Disorder
  • Early Development
  • Healthy Control Subjects
  • Autism Spectrum Disorders
  • Healthy Volunteer
  • HV

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by National Institute of Mental Health (NIMH) on 2026-08-24.