NCT02811211

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,894

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 21, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 23, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 6, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 6, 2017

Completed
Last Updated

July 6, 2021

Status Verified

February 1, 2017

Enrollment Period

11 months

First QC Date

June 21, 2016

Last Update Submit

July 2, 2021

Conditions

Attention Deficit Disorder With Hyperactivity

Outcome Measures

Primary Outcomes (1)

  • Presence of mGluR network mutations

    At study enrollment

Eligibility Criteria

Age6 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

A.I. DuPont Hospital for Children

Wilmington, Delaware, 19803, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Saliva

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2016

First Posted

June 23, 2016

Study Start

February 1, 2016

Primary Completion

January 6, 2017

Study Completion

January 6, 2017

Last Updated

July 6, 2021

Record last verified: 2017-02

Locations

US(1)