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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: Completed Phase 4 study, sponsored by Icahn School of Medicine at Mount Sinai.
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, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Measures of go/no-go task performance during functional magnetic resonance imaging. Performance on a go-nogo task inside the scanner.
Interventions
- DRUG Placebo
- DRUG Guanfacine Hydrochloride XR
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2011-03 |
| Est. Completion | 2013-12 |
| Phase | Phase 4 |
What the finished NCT01709695 record still lists
NCT01709695 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01709695 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01709695's enrollment target sits among peer trials
27 1651st of 2000 higher than 346 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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