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NCT04128683 · ClinicalTrials.gov registry record · Early Phase 1
Dopamine Receptor Contributions to Prediction Error and Reversal Learning in Anorexia Nervosa
A Early Phase 1 study, sponsored by University of California, San Diego.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 31
- Enrollment target
NCT04128683: Completed Early Phase 1 study, sponsored by University of California, San Diego.
NCT04128683 is a Early Phase 1 study that has completed, run by University of California, San Diego. The registered enrollment target is 31 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (42% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04128683, a Early Phase 1 study, has completed, sponsored by University of California, San Diego.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 31 participants
- Enrollment target
Study Summary
Anorexia nervosa (AN) is an eating disorder associated with intense fear of weight gain, food refusal, and severe weight loss. AN has the highest mortality rate among the psychiatric disorders; however, little is known about biomarkers, and no medication has been approved for AN. Many individuals only partially recover, and treatment options, especially for the psychological components of the illness, are not very effective, highlighting the need for more effective treatments. Brain reward pathways have a direct impact on the drive to eat, and a variety of neuroimaging studies have suggested altered reward processing in AN. The neurotransmitter dopamine has a central role in the reward circuitry to drive food approach, and the dynamic interplay between dopamine receptor response and food restriction could have implications for the pathophysiology of AN. Dopamine-related brain function has been studied indirectly using functional magnetic resonance brain imaging (fMRI) and tasks that deliver reward stimuli unexpectedly, that elicit the so-called prediction error (PE) response. Research in AN showed repeatedly altered PE processing suggesting altered dopamine circuit function in the disorder. Dopamine and PE response have also been associated with altered reversal learning, which has important treatment implication for AN as reversal learning is impaired in the disorder and modulation of the dopamine system could improve treatment.
Primary Outcome
This task measures responsiveness to unexpected stimulus in the dopamine related brain circuitry. Study participants in both the healthy control group and anorexia nervosa group completed 3 fMRI scans. Prior to each scan subjects were administered one of three study medications (amisulpride, bromocriptine, or placebo). During the fMRI scan, subjects completed a taste reward prediction error task where they viewed visual stimuli and then received one of three conditions: sweet taste, neutral tast
Interventions
- DRUG Placebo
- DRUG amisulpride
- DRUG bromocriptine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2020-10-20 |
| Est. Completion | 2025-01-01 |
| Phase | Early Phase 1 |
What the finished NCT04128683 record still lists
NCT04128683 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (42% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT04128683 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04128683 about?
NCT04128683 is a clinical study titled "Dopamine Receptor Contributions to Prediction Error and Reversal Learning in Anorexia Nervosa". Anorexia nervosa (AN) is an eating disorder associated with intense fear of weight gain, food refusal, and severe weight loss. AN has the highest mortality rate among the psychiatric disorders; however, little is known about biomarkers, and no medication has been approved for AN. Many individuals on...
What is the current status of trial NCT04128683?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 31 participants. The study started on 2020-10-20. Estimated completion is 2025-01-01.
What interventions are being tested in trial NCT04128683?
The interventions under investigation include: Placebo (DRUG), amisulpride (DRUG), bromocriptine (DRUG).
Who is sponsoring clinical trial NCT04128683?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04128683's enrollment target sits among peer trials
31 794th of 2000 higher than 1,194 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 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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