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NCT02148783 · ClinicalTrials.gov registry record · Phase 2
Dopamine Receptor Imaging to Predict Response to Stimulant Therapy in Chronic TBI
A Phase 2 study, sponsored by Uniformed Services University of the Health Sciences.
- Terminated
- Registry status
- Phase 2
- Development phase
- 11
- Enrollment target
NCT02148783: Clinical Trial Phase 2 study, sponsored by Uniformed Services University of the Health Sciences.
NCT02148783 is a Phase 2 study that was terminated before completion, run by Uniformed Services University of the Health Sciences. The registered enrollment target is 11 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02148783, a Phase 2 study, was terminated before completion, sponsored by Uniformed Services University of the Health Sciences.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 11 participants
- Enrollment target
Study Summary
Deficits in memory, attention, cognitive, and executive functions are the most common disabilities after traumatic brain injury (TBI). Dopamine (DA) neurotransmission is implicated in these neural functions and dopaminergic pathways are recognized to be frequently disrupted after TBI. One of the most widely used DAergic drugs is methylphenidate (Ritalin®). Methylphenidate increases synaptic DA levels by binding to presynaptic dopamine transporters (DAT) and blocking re-uptake. PET with methylphenidate challenge to measure tonic DA release provides valuable insight into the molecular basis of attention-deficit hyperactivity disorder (ADHD) and addiction, as well as practical information regarding likely effectiveness of therapy (1). The objectives of this study are to use PET imaging with \[11C\]-raclopride, a D2/D3 receptor ligand, before and after administering methylphenidate, to measure endogenous DA release in patients who are experiencing problems with cognition, attention and executive function in the chronic stage after TBI. In addition, we will use TMS to test short intracortical inhibition, a gamma-aminobutyric acid receptor A (GABAA) - mediated phenomenon, which is under partial DA control, as a measure of dopaminergic activity on and off methylphenidate.
Primary Outcome
Processing speed will be assessed as a composite score of the following measures: 1. Conners Continuous Performance Test (3rd Edition) 2. SeaShore Rhythm Test 3. Flanker Inhibitory Control and Attention Test 4. Pattern Comparison Processing Speed Test
Interventions
- DRUG Placebo
- DRUG methylphenidate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2014-09 |
| Est. Completion | 2018-08 |
| Phase | Phase 2 |
Why NCT02148783 stopped before completion
NCT02148783 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02148783 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02148783 about?
NCT02148783 is a clinical study titled "Dopamine Receptor Imaging to Predict Response to Stimulant Therapy in Chronic TBI". Deficits in memory, attention, cognitive, and executive functions are the most common disabilities after traumatic brain injury (TBI). Dopamine (DA) neurotransmission is implicated in these neural functions and dopaminergic pathways are recognized to be frequently disrupted after TBI. One of the mos...
What is the current status of trial NCT02148783?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 11 participants. The study started on 2014-09. Estimated completion is 2018-08.
What interventions are being tested in trial NCT02148783?
The interventions under investigation include: Placebo (DRUG), methylphenidate (DRUG).
Who is sponsoring clinical trial NCT02148783?
This trial is sponsored by Uniformed Services University of the Health Sciences, which has 27 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02148783's enrollment target sits among peer trials
11 1967th of 2000 higher than 33 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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