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

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

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.

Study Overview

• Status: Completed
• Conditions: Attention Deficit Hyperactivity Disorder

• Study Type: Observational
• Enrollment (Actual): 2503

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Wayne, Pennsylvania, United States, 19087
      • Aevi Genomic Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects between the ages of 6 and 17 years, who have been told that they have ADHD, will be eligible for screening.

Description

Inclusion Criteria:

1. 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.
2. Subject is 6 to 17 years of age (inclusive) at the time of informed consent.
3. Parent/LAR confirms that the subject has been diagnosed with or been told by a doctor that their child has ADHD.
4. Parent/LAR confirms that the subject is not pregnant and/or breastfeeding.

Exclusion Criteria:

1. 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.
2. 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.
3. Parent/LAR confirms that the subject has been genotyped previously in the MDGN-NFC1-ADHD-001, MDGN-NFC1-ADHD-101 clinical study.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Presence of specific copy number variants (CNVs) involved in glutamatergic signaling and neuronal connectivity	Day 1

Collaborators and Investigators

• Sponsor: Aevi Genomic Medicine, LLC, a Cerecor company
• Investigators: Principal Investigator: Andrew Cutler, MD, Meridien Research

Study record dates

Study Major Dates

• Study Start (Actual): August 14, 2017
• Primary Completion (Actual): August 3, 2018
• Study Completion (Actual): August 3, 2018

Study Registration Dates

• First Submitted: July 26, 2017
• First Submitted That Met QC Criteria: July 27, 2017
• First Posted (Actual): July 31, 2017

Study Record Updates

• Last Update Posted (Actual): July 6, 2021
• Last Update Submitted That Met QC Criteria: July 2, 2021
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity; Hyperkinesis
• Other Study ID Numbers: AEVI-001-ADHD-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No