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A Noninterventional Genotype/Phenotype Study of mGluR Mutations in Children and Adolescents With ADHD

A Noninterventional Genotype/Phenotype Study of mGluR Mutations in Children and Adolescents With Attention Deficit Hyperactivity Disorder (ADHD)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02811211
Enrollment
1894
Registered
2016-06-23
Start date
2016-02-29
Completion date
2017-01-06
Last updated
2021-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Attention Deficit Disorder With Hyperactivity

Brief summary

This noninterventional study will assess genomic changes in the metabotropic glutamate receptor (mGluR) network in children and adolescents with ADHD.

Detailed description

Male and female subjects 6 to 17 years of age with a primary psychiatric diagnosis of ADHD will be enrolled in this study. The subject and his or her parent/guardian must agree to genotyping to determine whether the subject has disruptive mutations within any of the approximately 274 mGluR-network genes, and complete an interview that will include information about the subject's ADHD history, treatment, and co-morbidities.

Interventions

None listed

Sponsors

Aevi Genomic Medicine, LLC, a Cerecor company
Lead SponsorINDUSTRY

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No

Inclusion criteria

* The subject is male or female ≥6 and ≤17 years of age. * The subject has ADHD as defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th edition. * The subject, his or her legally responsible representative, and investigator agree to complete ADHD history, treatment, and comorbidity electronic case report form (eCRF).

Exclusion criteria

* The subject or parent/legal guardian is in the opinion of the investigator mentally or legally incapacitated and unable to provide informed consent/assent for participation in the study.

Design outcomes

Primary

MeasureTime frame
Presence of mGluR network mutationsAt study enrollment

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026