CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 27 enrolled
Drug / intervention
Guanfacine Hydrochloride XR +1 moredrug
Likely dose
Guanfacine Hydrochloride XR 4mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01709695
NCT01709695Phase 4Completed

Neurobiological Basis of Response to Guanfacine Extended Release in Children and Adolescents With Attention-deficit/Hyperactivity Disorder (ADHD): an Functional Magnetic Resonance Imaging(fMRI) Study of Brain Activation Pre and Post Treatment

Icahn School of Medicine at Mount Sinai·interventional·Posted Oct 18, 2012·Updated Feb 14, 2018

In Brief

A Phase 4 clinical trial evaluating Guanfacine Hydrochloride XR and Placebo for ADHD and Attention Deficit Hyperactivity Disorder. Completed, enrolled 27 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedOct 18, 2012
Enrollment StartMar 1, 2011
Primary CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 13.7 years ago

Interventions

Guanfacine Hydrochloride XRdrug

Weekly adjustments based on parent ratings of symptoms, side effects, and health status per vital signs up to 4mg maximum dose

Placebodrug

Weekly adjustments based on parent ratings of symptoms, side effects, and health status per vital signs up to 4mg maximum dose