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Completed

NCT Number: NCT02811211

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

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

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Key information

Conditions

Attention Deficit Disorder With Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

A.I. DuPont Hospital for Children

Wilmington, Delaware, 19803, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Presence of mGluR network mutations

    Time frame: At study enrollment

Sponsors and collaborators

Lead sponsor

Aevi Genomic Medicine, LLC, a Cerecor company

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 23, 2016
Registry last updated
Jul 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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