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

NCT03233867 | Completed

• 1 other identifier: AEVI-001-ADHD-002
• Study Type: observational
• Target: 2,503
• Locations: 1 country
• Sites: 1

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.

Conditions

Attention Deficit Hyperactivity Disorder

Outcome Measures

Primary Outcomes (1)

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

  Day 1

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aevi Genomic Medicine, LLC, a Cerecor company: lead

Study Sites (1)

Aevi Genomic Medicine

Wayne, Pennsylvania, 19087, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Saliva

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Andrew Cutler, MD

  Meridien Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2017
• First Posted: July 31, 2017
• Study Start: August 14, 2017
• Primary Completion: August 3, 2018
• Study Completion: August 3, 2018
• Last Updated: July 6, 2021

Record last verified: 2018-11

Locations

US (1)