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

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ClinicalTrials.gov Identifier: NCT02811211
Recruitment Status : Completed
First Posted : June 23, 2016
Last Update Posted : March 7, 2017
Sponsor:
Information provided by (Responsible Party):
Aevi Genomic Medicine

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
Attention Deficit Disorder With Hyperactivity

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 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 : February 2016
Actual Primary Completion Date : January 6, 2017
Actual Study Completion Date : January 6, 2017

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Presence of mGluR network mutations [ Time Frame: At study enrollment ]

Biospecimen Retention:   Samples With DNA
Saliva


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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects between the ages of 6 years and 17 years of age with a previously established diagnosis of ADHD will be eligible for screening.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02811211


Locations
United States, Delaware
A.I. DuPont Hospital for Children
Wilmington, Delaware, United States, 19803
Sponsors and Collaborators
Aevi Genomic Medicine

Responsible Party: Aevi Genomic Medicine
ClinicalTrials.gov Identifier: NCT02811211     History of Changes
Other Study ID Numbers: MDGN-NFC1-ADHD-001
First Posted: June 23, 2016    Key Record Dates
Last Update Posted: March 7, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms