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

Attention Deficit Hyperactivity Disorder Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03233867
• Other study ID #: AEVI-001-ADHD-002
• Status: Completed
• Start date: August 14, 2017
• Est. completion date: August 3, 2018

Study information

• Verified date: November 2018
• Source: Cerecor Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2503
• Est. completion date: August 3, 2018
• Est. primary completion date: August 3, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Hyperkinesis

Locations

Country	Name	City	State
United States	Aevi Genomic Medicine	Wayne	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Aevi Genomic Medicine, LLC, a Cerecor company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of specific copy number variants (CNVs) involved in glutamatergic signaling and neuronal connectivity		Day 1