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

Aevi Genomic Medicine, LLC, a Cerecor company1 site in 1 country2,503 target enrollmentAugust 14, 2017

ConditionsAttention Deficit Hyperactivity Disorder

Overview

Phase: N/A
Intervention: Not specified
Conditions: Attention Deficit Hyperactivity Disorder
Sponsor: Aevi Genomic Medicine, LLC, a Cerecor company
Enrollment: 2503
Locations: 1
Primary Endpoint: Presence of specific copy number variants (CNVs) involved in glutamatergic signaling and neuronal connectivity
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 14, 2017

End Date

August 3, 2018

Last Updated

4 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Aevi Genomic Medicine, LLC, a Cerecor company

Responsible Party

Sponsor

Eligibility Criteria

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.