Longitudinal Family/Molecular Genetic Study to Validate Research Domain Criteria

Mental Disorders Clinical Trial

Official title:

Longitudinal Family/Molecular Genetic Study to Validate Research Domain Criteria

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02415647
• Other study ID #: 543389-8
• Secondary ID: R01MH101519-01A1
• Status: Completed
• Start date: October 2014
• Est. completion date: May 31, 2020

Study information

• Verified date: May 2024
• Source: State University of New York - Upstate Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2806
• Est. completion date: May 31, 2020
• Est. primary completion date: September 13, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Mental Disorders
• Mental Disorders Diagnosed in Childhood
• Neurodevelopmental Disorders
• Psychiatric, Diagnosis
• Psychological Disorders
• Psychotic Disorders

Locations

Country	Name	City	State
United States	Upstate Medical University	Syracuse	New York

Sponsors (2)

Lead Sponsor	Collaborator
State University of New York - Upstate Medical University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (10)

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. Erratum In: Lancet. 2013 Apr 20;381(9875):1360. Lancet. 2013 Apr 20;381(9875):1360. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reward Valuation	Measures: Self-report, computerized tests, and DNA samples; Assessing correlations among family members and predictors of psychopathology.	Baseline
Primary	Effort Valuation/Willingness to Work	Measures: Self-report, computerized tests, and DNA samples; Assessing correlations among family members and predictors of psychopathology.	Baseline
Primary	Expectancy/Reward Prediction Error	Measures: Self-report, computerized tests, and DNA samples; Assessing correlations among family members and predictors of psychopathology.	Baseline
Primary	Initial Responsiveness to Reward Attainment	Measures: Self-report, computerized tests, and DNA samples; Assessing correlations among family members and predictors of psychopathology.	Baseline