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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 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.
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.
Interventions
- DRUG Placebo
- DRUG methylphenidate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2014-09 |
| Est. Completion | 2018-08 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02148783
The ClinicalTrials.gov registry entry for NCT02148783 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Uniformed Services University of the Health Sciences, which has 27 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02148783 reports 0 study locations.
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.
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