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Completed

NCT Number: NCT03233867

A Non-interventional Study to Identify Children and Adolescents With ADHD and With or Without mGLuR Mutations

This is a non-interventional study in children and adolescents (ages 6-17 years) with attention deficit hyperactivity disorder (ADHD) to assess CNVs in specific genes involved in glutamatergic signaling and neuronal connectivity. The screening in this study will be conducted through a combination of online and site performed activities.

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Key information

Conditions

Attention Deficit Hyperactivity Disorder 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

Aevi Genomic Medicine

Wayne, Pennsylvania, 19087, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Parent/legally authorized representative (LAR) can speak and read English fluently, have provided informed consent and agree to be contacted for an interventional study prior to being genotyped.
  • Subject is 6 to 17 years of age (inclusive) at the time of informed consent.
  • Parent/LAR confirms that the subject has been diagnosed with or been told by a doctor that their child has ADHD.
  • Parent/LAR confirms that the subject is not pregnant and/or breastfeeding.

Exclusion criteria

  • Parent/LAR confirms that the subject has been diagnosed with any of the following conditions (aside from ADHD): conduct disorder, anxiety disorder, major depression, autism spectrum disorder (ASD), bipolar disease, psychosis, hypertension, seizure disorder, syncope, or other serious cardiac problems.
  • Aside from your child's current ADHD medication (if applicable), parent/LAR confirms that the subject is currently taking any of the following medications: antidepressants, anti-anxiety medications, anti-psychotics, and/or mood stabilizers.
  • Parent/LAR confirms that the subject has been genotyped previously in the MDGN-NFC1-ADHD-001, MDGN-NFC1-ADHD-101 clinical study.

Treatment and study plan

Primary outcomes

  1. Presence of specific copy number variants (CNVs) involved in glutamatergic signaling and neuronal connectivity

    Time frame: Day 1

Sponsors and collaborators

Lead sponsor

Aevi Genomic Medicine, LLC, a Cerecor company

Industry

Registry information

Official study title

A Non-interventional Study to Identify Children and Adolescents (Ages 6-17 Years) With Attention Deficit Hyperactivity Disorder and With or Without Copy Number Variants in Specific Genes Involved in Glutamatergic Signaling and Neuronal Connectivity

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 31, 2017
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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