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

Sponsor
Aevi Genomic Medicine, LLC, a Cerecor company (Industry)
Overall Status
Completed
CT.gov ID
NCT02811211
Collaborator
(none)
1,894
Enrollment
1
Location
11.2
Duration (Months)
169.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    Detailed 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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    1894 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Cross-Sectional
    Official Title:
    A Noninterventional Genotype/Phenotype Study of mGluR Mutations in Children and Adolescents With Attention Deficit Hyperactivity Disorder (ADHD)
    Study Start Date :
    Feb 1, 2016
    Actual Primary Completion Date :
    Jan 6, 2017
    Actual Study Completion Date :
    Jan 6, 2017

    Outcome Measures

    Primary Outcome Measures

    1. Presence of mGluR network mutations [At study enrollment]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Years to 17 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 A.I. DuPont Hospital for Children Wilmington Delaware United States 19803

    Sponsors and Collaborators

    • Aevi Genomic Medicine, LLC, a Cerecor company

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Aevi Genomic Medicine, LLC, a Cerecor company
    ClinicalTrials.gov Identifier:
    NCT02811211
    Other Study ID Numbers:
    • MDGN-NFC1-ADHD-001
    First Posted:
    Jun 23, 2016
    Last Update Posted:
    Jul 6, 2021
    Last Verified:
    Feb 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Additional relevant MeSH terms:
    Hyperkinesis
    Attention Deficit Disorder with Hyperactivity

    Study Results

    No Results Posted as of Jul 6, 2021