Longitudinal Family/Molecular Genetic Study to Validate Research Domain Criteria

NCT ID: NCT02415647

Last Updated: 2024-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

2806 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-10-31

Study Completion Date

2020-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this research is to study new ways of classifying mental disorders in children based on observable behavior and genetics to ultimately diagnose these disorders better.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The NIMH Research Domain Criteria (RDoC) initiative seeks to further a long-range goal of contributing to diagnostic systems as informed by research on genetics, neuroscience, and behavior. The RDoC approach is based on identifying the most elemental units of analysis relevant to psychiatric disorders (such as genes and molecules) and using this matrix as a framework for investigation. In this case-control family study, the investigators will be using self-report questionnaires and computer-based tests to develop diagnostic methods for neuropsychiatric disorders in children, their siblings, and their parents. They will do this by recruiting "normal" and "affected" children, their siblings, and their parents. They will look at the subject, sibling, and parents to determine if psychiatric disorders are inherited. "Affected" children, ages 6-12, are those who have been diagnosed with a psychiatric disorder. Participants will undergo a battery of questionnaires/evaluations and a blood draw. The investigators will determine if the questionnaires and tests that reflect the constructs (such as reward prediction and willingness to work) predict psychopathology and impairment. The blood draw will be genotyped to determine if the measured constructs are associated with neuropsychiatric candidate genes, cross-disorder candidate gens and a cross-disorder polygenic score.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Mental Disorders Psychological Disorders Psychiatric, Diagnosis Mental Disorders Diagnosed in Childhood

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Child Proband with Psychiatric Disorder

Affected group of child probands with psychiatric disorders (ages 6-12 years).

No interventions assigned to this group

Normal Comparison Group

Non-disordered psychiatrically normal comparison group (ages 6-12 years).

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* male or female, ages 6-12.
* biological child of parent(s) participating in testing.

Exclusion Criteria

* taking psychotropic medications.
* free of uncontrolled medical problems.
* major sensorimotor disability (e.g., deafness, blindness).
* diagnosed neurological condition.
* inadequate command of the English language.
* history of head injury with loss of consciousness lasting longer than 10 minutes.
* IQ estimated at below 80.
Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

State University of New York - Upstate Medical University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Stephen V. Faraone

Faculty

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Stephen Faraone, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Upstate Medical University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Upstate Medical University

Syracuse, New York, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Glatt SJ, Stone WS, Faraone SV, Seidman LJ, Tsuang MT. Psychopathology, personality traits and social development of young first-degree relatives of patients with schizophrenia. Br J Psychiatry. 2006 Oct;189:337-45. doi: 10.1192/bjp.bp.105.016998.

Reference Type BACKGROUND
PMID: 17012657 (View on PubMed)

Faraone SV, Seidman LJ, Kremen WS, Kennedy D, Makris N, Caviness VS, Goldstein J, Tsuang MT. Structural brain abnormalities among relatives of patients with schizophrenia: implications for linkage studies. Schizophr Res. 2003 Apr 1;60(2-3):125-40. doi: 10.1016/s0920-9964(02)00304-3.

Reference Type BACKGROUND
PMID: 12591577 (View on PubMed)

Faraone SV, Su J, Tsuang MT. A genome-wide scan of symptom dimensions in bipolar disorder pedigrees of adult probands. J Affect Disord. 2004 Oct;82 Suppl 1:S71-8. doi: 10.1016/j.jad.2004.05.015.

Reference Type BACKGROUND
PMID: 15571792 (View on PubMed)

Glatt SJ, Su JA, Zhu SC, Zhang R, Zhang B, Li J, Yuan X, Li J, Lyons MJ, Faraone SV, Tsuang MT. Genome-wide linkage analysis of heroin dependence in Han Chinese: results from wave one of a multi-stage study. Am J Med Genet B Neuropsychiatr Genet. 2006 Sep 5;141B(6):648-52. doi: 10.1002/ajmg.b.30361.

Reference Type BACKGROUND
PMID: 16856125 (View on PubMed)

Glatt SJ, Faraone SV, Lasky-Su JA, Kanazawa T, Hwu HG, Tsuang MT. Family-based association testing strongly implicates DRD2 as a risk gene for schizophrenia in Han Chinese from Taiwan. Mol Psychiatry. 2009 Sep;14(9):885-93. doi: 10.1038/mp.2008.30. Epub 2008 Mar 11.

Reference Type BACKGROUND
PMID: 18332877 (View on PubMed)

Cross-Disorder Group of the Psychiatric Genomics Consortium. Identification of risk loci with shared effects on five major psychiatric disorders: a genome-wide analysis. Lancet. 2013 Apr 20;381(9875):1371-1379. doi: 10.1016/S0140-6736(12)62129-1. Epub 2013 Feb 28.

Reference Type BACKGROUND
PMID: 23453885 (View on PubMed)

Faraone SV, Matise T, Svrakic D, Pepple J, Malaspina D, Suarez B, Hampe C, Zambuto CT, Schmitt K, Meyer J, Markel P, Lee H, Harkavy Friedman J, Kaufmann C, Cloninger CR, Tsuang MT. Genome scan of European-American schizophrenia pedigrees: results of the NIMH Genetics Initiative and Millennium Consortium. Am J Med Genet. 1998 Jul 10;81(4):290-5.

Reference Type BACKGROUND
PMID: 9674973 (View on PubMed)

Faraone SV, Biederman J, Mick E, Wozniak J, Kiely K, Guite J, Ablon JS, Warburton R, Reed E. Attention deficit hyperactivity disorder in a multigenerational pedigree. Biol Psychiatry. 1996 May 15;39(10):906-8. doi: 10.1016/0006-3223(95)00194-8. No abstract available.

Reference Type BACKGROUND
PMID: 8860195 (View on PubMed)

Faraone SV, Adamson JJ, Wilens TE, Monuteaux MC, Biederman J. Deriving phenotypes for molecular genetic studies of substance use disorders: a family study approach. Drug Alcohol Depend. 2007 May 11;88(2-3):244-50. doi: 10.1016/j.drugalcdep.2006.11.002. Epub 2006 Dec 1.

Reference Type BACKGROUND
PMID: 17141426 (View on PubMed)

Faraone SV, Adamson JJ, Wilens TE, Monuteaux MC, Biederman J. Familial transmission of derived phenotypes for molecular genetic studies of substance use disorders. Drug Alcohol Depend. 2008 Jan 1;92(1-3):100-7. doi: 10.1016/j.drugalcdep.2007.07.002. Epub 2007 Sep 4.

Reference Type BACKGROUND
PMID: 17766060 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R01MH101519-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

543389-8

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.