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

Completed

• Conditions: Attention Deficit Hyperactivity Disorder

• Registration Number: NCT03233867
• Lead Sponsor: Aevi Genomic Medicine, LLC, a Cerecor company

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-07-26
• Study First Submitted QC: 2017-07-27
• Study First Posted: 2017-07-31
• Study Start: 2017-08-14
• Primary Completion: 2018-08-03
• Study Completion: 2018-08-03
• Status Verified: 2018-11
• Last Update Submitted: 2021-07-02
• Last Update Posted: 2021-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2503

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Presence of specific copy number variants (CNVs) involved in glutamatergic signaling and neuronal connectivity	Day 1

Trial Locations

Locations (1)

Aevi Genomic Medicine; 🇺🇸 Wayne, Pennsylvania, United States