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NCT01709695 · ClinicalTrials.gov registry record · Phase 4

Neurobiological Basis of Response to Guanfacine Extended Release in Children and Adolescents With ADHD

A Phase 4 study, sponsored by Icahn School of Medicine at Mount Sinai.

Completed
Registry status
Phase 4
Development phase
27
Enrollment target

NCT01709695 is a Phase 4 study that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 27 participants.

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The verdict

NCT01709695, a Phase 4 study, has completed, sponsored by Icahn School of Medicine at Mount Sinai.

COMPLETED
Registry status
Phase 4
Development phase
27 participants
Enrollment target

Study Summary

This study proposes to evaluate the effects of guanfacine extended release on brain activation during fMRI in children and adolescents with ADHD between the ages 8-15 and ADHD subjects randomized to placebo treatment. This study also proposes to collect DNA on study participants, to examine the genetic underpinning of the observed fMRI activation profiles at baseline and in response to treatment. The purpose is to examine polymorphisms of the adrenergic 2A gene (and other related targets) for genetic biomarkers in association with the fMRI findings of this study.

Interventions

  • DRUG Placebo
  • DRUG Guanfacine Hydrochloride XR

Trial Details

FieldValue
Enrollment Target 27 participants
Start Date 2011-03
Est. Completion 2013-12
Phase Phase 4

What the Registry Record Tells You About NCT01709695

The ClinicalTrials.gov registry entry for NCT01709695 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Icahn School of Medicine at Mount Sinai, which has 708 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT01709695 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01709695 about?

NCT01709695 is a clinical study titled "Neurobiological Basis of Response to Guanfacine Extended Release in Children and Adolescents With ADHD". This study proposes to evaluate the effects of guanfacine extended release on brain activation during fMRI in children and adolescents with ADHD between the ages 8-15 and ADHD subjects randomized to placebo treatment. This study also proposes to collect DNA on study participants, to examine the gen...

What is the current status of trial NCT01709695?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 27 participants. The study started on 2011-03. Estimated completion is 2013-12.

What interventions are being tested in trial NCT01709695?

The interventions under investigation include: Placebo (DRUG), Guanfacine Hydrochloride XR (DRUG).

Who is sponsoring clinical trial NCT01709695?

This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.