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Trial record 24 of 94 for:    ADHD | Recruiting, Not yet recruiting, Available Studies | United States | Child, Adult

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

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ClinicalTrials.gov Identifier: NCT03233867
Recruitment Status : Recruiting
First Posted : July 31, 2017
Last Update Posted : November 17, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease
Attention Deficit Hyperactivity Disorder

Study Design

Study Type : Observational
Estimated Enrollment : 5000 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: A Non-interventional Study to Identify Children and Adolescents (Ages 6-17 Years) With Attention Deficit Hyperactivity Disorder and With or Without Copy Number Variants in Specific Genes Involved in Glutamatergic Signaling and Neuronal Connectivity
Actual Study Start Date : August 14, 2017
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. Presence of specific copy number variants (CNVs) involved in glutamatergic signaling and neuronal connectivity [ Time Frame: Day 1 ]

Biospecimen Retention:   Samples With DNA
Saliva

Eligibility Criteria

Information from the National Library of Medicine

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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 and 17 years, who have been told that they have ADHD, will be eligible for screening.
Criteria

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.
Contacts and Locations

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): NCT03233867


Contacts
Contact: Aevi Genomic Medicine 1-877-271-9623 AEVI-001-ADHD-002@aevigenomics.com

Locations
United States, Pennsylvania
Aevi Genomic Medicine Recruiting
Wayne, Pennsylvania, United States, 19087
Contact: Aevi Genomic Medicine         
Sponsors and Collaborators
Aevi Genomic Medicine
Investigators
Principal Investigator: Andrew Cutler, MD Meridien Research
More Information

Responsible Party: Aevi Genomic Medicine
ClinicalTrials.gov Identifier: NCT03233867     History of Changes
Other Study ID Numbers: AEVI-001-ADHD-002
First Posted: July 31, 2017    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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