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NCT02478788 · ClinicalTrials.gov registry record · Phase 4
Neuroimaging Study of Risk Factors for Adolescent Bipolar Disorder
A Phase 4 study, sponsored by University of Cincinnati.
- Completed
- Registry status
- Phase 4
- Development phase
- 153
- Enrollment target
NCT02478788: Completed Phase 4 study, sponsored by University of Cincinnati.
NCT02478788 is a Phase 4 study that has completed, run by University of Cincinnati. The registered enrollment target is 153 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02478788, a Phase 4 study, has completed, sponsored by University of Cincinnati.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 153 participants
- Enrollment target
Study Summary
The main purpose of this study is to see the affects of the study medication called mixed amphetamine salts-extended release (MAS-XR) on brain function by taking brain pictures. The researchers also want to see if MAS-XR makes your child more or less likely to develop problems like acting out (i.e. periods of irritability, agitation, aggression). MAS-XR is approved by the United States Food and Drug Administration (FDA) to treat attention deficit hyperactivity disorder (ADHD) in adults, children and adolescents.
Primary Outcome
Using functional magnetic resonance imaging (fMRI), change in prefrontal-amygdala functional connectivity will be determined by contrasting baseline and endpoint blood oxygen level-dependent (BOLD) activity in the amygdala and prefrontal cortex (BA47) during performance of the CPT-END task, and determining the prefrontal-amygdala interrelationship using a seed-region (amygdala) based functional connectivity analysis.
Interventions
- DRUG Placebo
- DRUG mixed amphetamine salts-extended release (MAS-XR)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 153 participants |
| Start Date | 2015-11 |
| Est. Completion | 2022-12 |
| Phase | Phase 4 |
What the finished NCT02478788 record still lists
NCT02478788 is an interventional study that assigns participants to a tested intervention. The registered 153 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02478788 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02478788 about?
NCT02478788 is a clinical study titled "Neuroimaging Study of Risk Factors for Adolescent Bipolar Disorder". The main purpose of this study is to see the affects of the study medication called mixed amphetamine salts-extended release (MAS-XR) on brain function by taking brain pictures. The researchers also want to see if MAS-XR makes your child more or less likely to develop problems like acting out (i.e. ...
What is the current status of trial NCT02478788?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 153 participants. The study started on 2015-11. Estimated completion is 2022-12.
What interventions are being tested in trial NCT02478788?
The interventions under investigation include: Placebo (DRUG), mixed amphetamine salts-extended release (MAS-XR) (DRUG).
Who is sponsoring clinical trial NCT02478788?
This trial is sponsored by University of Cincinnati, which has 245 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02478788's enrollment target sits among peer trials
153 530th of 2000 higher than 1,471 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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