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

NCT ID: NCT02811211

Last Updated: 2021-07-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1894 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-02-29

Study Completion Date

2017-01-06

Brief Summary

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

Detailed Description

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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.

Conditions

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Attention Deficit Disorder With Hyperactivity

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aevi Genomic Medicine, LLC, a Cerecor company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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A.I. DuPont Hospital for Children

Wilmington, Delaware, United States

Site Status

Countries

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United States

Other Identifiers

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MDGN-NFC1-ADHD-001

Identifier Type: -

Identifier Source: org_study_id

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