CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 31 enrolled
Drug / intervention
amisulpride +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04128683
NCT04128683Early Ph 1Completed

Toward Understanding Dopamine Receptor Contributions to Prediction Error and Reversal Learning in Anorexia Nervosa

University of California, San Diego·interventional·Posted Oct 16, 2019·Updated Apr 11, 2025

In Brief

A Early Phase 1 clinical trial evaluating amisulpride, bromocriptine, and 1 other intervention for Anorexia Nervosa. Completed, enrolled 31 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Early Ph 1CompletedFinished
2020202120222023202420252026
First PostedOct 16, 2019
Enrollment StartOct 20, 2020
Primary CompletionSep 6, 2023
Study CompletionJan 1, 2025
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 6.7 years ago

Interventions

amisulpridedrug

Dopamine D2 antagonist to test how it affects brain response and behavior to prediction error and reversal tasks during functional magnetic resonance imaging (fMRI).

bromocriptinedrug

Dopamine D2 receptor agonist test how it affects brain response and behavior to prediction error and reversal tasks during functional magnetic resonance imaging (fMRI).

Placebodrug

Placebo pill with no active drug ingredients