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

NCT ID: NCT03233867

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

2503 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-08-14

Study Completion Date

2018-08-03

Brief Summary

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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.

Detailed Description

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Conditions

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Attention Deficit Hyperactivity Disorder

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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.
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

Principal Investigators

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Andrew Cutler, MD

Role: PRINCIPAL_INVESTIGATOR

Meridien Research

Locations

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Aevi Genomic Medicine

Wayne, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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AEVI-001-ADHD-002

Identifier Type: -

Identifier Source: org_study_id

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