A Noninterventional Genotype/Phenotype Study of mGluR Mutations in Children and Adolescents With ADHD

Attention Deficit Disorder With Hyperactivity Clinical Trial

Official title:

A Noninterventional Genotype/Phenotype Study of mGluR Mutations in Children and Adolescents With Attention Deficit Hyperactivity Disorder (ADHD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02811211
• Other study ID #: MDGN-NFC1-ADHD-001
• Status: Completed
• Start date: February 2016
• Est. completion date: January 6, 2017

Study information

• Verified date: February 2017
• Source: Cerecor Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This noninterventional study will assess genomic changes in the metabotropic glutamate receptor (mGluR) network in children and adolescents with ADHD.

Description:

Male and female subjects 6 to 17 years of age with a primary psychiatric diagnosis of ADHD will be enrolled in this study. The subject and his or her parent/guardian must agree to genotyping to determine whether the subject has disruptive mutations within any of the approximately 274 mGluR-network genes, and complete an interview that will include information about the subject's ADHD history, treatment, and co-morbidities.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1894
• Est. completion date: January 6, 2017
• Est. primary completion date: January 6, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

Inclusion Criteria:

• The subject is male or female =6 and =17 years of age.

• The subject has ADHD as defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th edition.

• The subject, his or her legally responsible representative, and investigator agree to complete ADHD history, treatment, and comorbidity electronic case report form (eCRF).

Exclusion Criteria:

• The subject or parent/legal guardian is in the opinion of the investigator mentally or legally incapacitated and unable to provide informed consent/assent for participation in the study.

Related Conditions & MeSH terms

• Attention Deficit Disorder With Hyperactivity
• Hyperkinesis

Locations

Country	Name	City	State
United States	A.I. DuPont Hospital for Children	Wilmington	Delaware

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 mGluR network mutations		At study enrollment