Anorexia NervosaEarly Phase 1NCT04128683

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

A Early Phase 1 study testing amisulpride and bromocriptine in people with Anorexia Nervosa, run by University of California, San Diego at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 29 years, women onlyHealthy volunteers can take part
Conditions the study is for: Anorexia Nervosa
What is being tested?: amisulpride and bromocriptine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 31 participants
Where: 1 siteUnited States
Study dates: 20 Oct 2020to 1 Jan 2025
Phase: Early Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 29 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

Healthy Controls
Females ages 18-29 years
Healthy body weight between 90 and 110 % average body weight since puberty.
Regular monthly menstrual cycle
Edinburgh Handedness Inventory Revised (EHI-R) LQ* score > +200
English is primary language spoken

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Restricting Type Anorexia Nervosa
Females ages 18-29 years
Diagnostic criteria. Current diagnosis of AN, including being underweight below 17.5 body mass index (BMI, kg/m2), will have a severe fear of weight gain, body image distortion and absence of the menstrual cycle over three consecutive months.
First 1-2 weeks in treatment at The University of California San Diego Eating Disorders Center for Treatment and Research or Rady Children's Hospital San Diego Medical Behavioral Unit.
Restricting subtype, that is without binge/purge behaviors
Edinburgh Handedness Inventory Revised (EHI-R) LQ* score > +200
English is primary language spoken

Who cannot join

Healthy Controls
Current pregnancy or breast feeding within last 3 months
Illiterate/Blind individuals
First degree relative with current or past eating disorder
Current Medications other than BCP or IUD
Contraindications to amisulpride or bromocriptine (as determined through medical history in bioscreen and PI interview) including: Syncopal migraine; Uncontrolled hypertension; Pheochromocytoma; Prolactinoma; Breast cancer; hypersensitivity/allergy to amisulpride or bromocriptine; History of long QT syndrome; Family history of sudden death or long QT syndrome; History of seizures or seizure disorder

Show all 31Show fewer

Past or present Axis I psychiatric disorder including substance or alcohol use disorder as determined through SCID-5 clinical interview
Major Medical illness (as determined through medical history in bioscreen and PI interview) such as:
o Conditions that are life threatening: cancer heart disease stroke HIV/AIDS
o Conditions that are life threatening Conditions that cause serious disability without necessarily being life threatening: stroke closed head or spinal cord injuries mental retardation congenital malformations.
o Conditions that cause significant pain or discomfort that can cause serious interruptions to life activities: severe allergies migraine arthritis sickle cell disease
o Conditions that require major commitments of time and effort from care-givers for a substantial period of time: mobility disorders blindness Alzheimer's disease and other dementias chronic obstructive pulmonary disease paraplegia or quadriplegia Down's syndrome depression
o Conditions that may require frequent monitoring: diabetes conditions requiring anticoagulation treatment severe asthma severe allergies schizophrenia and other psychotic illnesses.
o Conditions that predict or are associated with severe consequences: hypertension (associated with heart disease) depression (associated with suicide) diabetes (associated with blindness, kidney failure) alcohol and other substance abuse (associated with intentional and unintentional injuries).
Recent history of suspected substance abuse or a lifetime history of psychostimulant abuse and/or dependence
Metal implants or braces (as determined through fMRI screening form)
Anorexia Nervosa
Pregnancy or breast feeding within last 3 months
Lifetime history of bipolar disorder or psychosis
Illiterate/Blind individuals
Contraindications to amisulpride or bromocriptine (as determined through medical history in bioscreen and PI interview) including: Syncopal migraine; Uncontrolled hypertension; Pheochromocytoma; Prolactinoma; Breast cancer; hypersensitivity/allergy to amisulpride or bromocriptine; History of long QT syndrome; Family history of sudden death or long QT syndrome; History of seizures or seizure disorder
Use of an anti-psychotic or other dopamine acting medication including stimulants within the past week at time of MRI
Recent history of substance abuse or dependence (within the last month)
Major Medical illness (as determined through medical history in bioscreen and PI interview) such as:
o Conditions that are life threatening: cancer heart disease stroke HIV/AIDS
o Conditions that are life threatening Conditions that cause serious disability without necessarily being life threatening: stroke closed head or spinal cord injuries mental retardation congenital malformations.
o Conditions that cause significant pain or discomfort that can cause serious interruptions to life activities: severe allergies migraine arthritis sickle cell disease
o Conditions that require major commitments of time and effort from care-givers for a substantial period of time: mobility disorders blindness Alzheimer's disease and other dementias chronic obstructive pulmonary disease paraplegia or quadriplegia Down's syndrome
o Conditions that may require frequent monitoring: diabetes conditions requiring anticoagulation treatment severe asthma severe allergies schizophrenia and other psychotic illnesses.
o Conditions that predict or are associated with severe consequences: hypertension (associated with heart disease) diabetes (associated with blindness, kidney failure) alcohol and other substance abuse (associated with intentional and unintentional injuries) within the last month
Metal implants or braces (as determined through fMRI screening form)

Trial locations and contacts

1 site in 1 country.

United States1 site

University of California San Diego
San Diego, California, 92121

Other trials in United States

About this study

Official title: Toward Understanding 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 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.

Conditions: Anorexia Nervosa
Being tested: amisulpride, bromocriptine, Placebo
Medical subject headings: Anorexia Nervosa

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

amisulprideDrug
Also called Solian
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
Also called Parlodel
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

Study groups in NCT04128683
Study group	Role	What they receive
Healthy Controls, Scan1: Placebo; Scan2: Amisulpride; Scan3: Bromocriptine	Experimental	Individuals in the healthy control group were randomized to the following scan order. Participants were administered a study medication or placebo 3 hours prior to the start of the scan. The participant did not know what study medication they received for each scan: Scan 1: Placebo(single dose, 3 hours pre-scan) Scan 2: Amisulpride (single dose, 400 mg, 3 hours pre-scan) Scan 3: Bromocriptine (single dose, 1.25 mg, 3 hours pre-scan) Receives: Drug: amisulpride; Drug: bromocriptine; Drug: Placebo
Healthy Controls, Scan1: Placebo; Scan2: Bromocriptine; Scan3: Amisulpride;	Experimental	Individuals in the healthy control group were randomized to the following scan order. Participants were administered a study medication or placebo 3 hours prior to the start of the scan. The participant did not know what study medication they received for each scan: Scan 1: Placebo(single dose, 3 hours pre-scan) Scan 2: Bromocriptine (single dose, 1.25 mg, 3 hours pre-scan) Scan 3: Amisulpride (single dose, 400 mg, 3 hours pre-scan) Receives: Drug: amisulpride; Drug: bromocriptine; Drug: Placebo
Healthy Controls, Scan1: Amisulpride; Scan2: Placebo; Scan3: Bromocriptine	Experimental	Individuals in the healthy control group were randomized to the following scan order. Participants were administered a study medication or placebo 3 hours prior to the start of the scan. The participant did not know what study medication they received for each scan: Scan 1: Amisulpride (single dose, 400 mg, 3 hours pre-scan) Scan 2: Placebo(single dose, 3 hours pre-scan) Scan 3: Bromocriptine (single dose, 1.25 mg, 3 hours pre-scan) Receives: Drug: amisulpride; Drug: bromocriptine; Drug: Placebo
Healthy Controls, Scan1: Amisulpride; Scan2: Bromocriptine; Scan1: Placebo	Experimental	Individuals in the healthy control group were randomized to the following scan order. Participants were administered a study medication or placebo 3 hours prior to the start of the scan. The participant did not know what study medication they received for each scan: Scan 1: Amisulpride (single dose, 400 mg, 3 hours pre-scan) Scan 2: Bromocriptine (single dose, 1.25 mg, 3 hours pre-scan) Scan 3: Placebo(single dose, 3 hours pre-scan) Receives: Drug: amisulpride; Drug: bromocriptine; Drug: Placebo
Healthy Controls, Scan1: Bromocriptine; Scan2: Placebo; Scan 3: Amisulpride	Experimental	Individuals in the healthy control group were randomized to the following scan order. Participants were administered a study medication or placebo 3 hours prior to the start of the scan. The participant did not know what study medication they received for each scan: Scan 1: Bromocriptine (single dose, 1.25 mg, 3 hours pre-scan) Scan 2: Placebo(single dose, 3 hours pre-scan) Scan 3: Amisulpride (single dose, 400 mg, 3 hours pre-scan) Receives: Drug: amisulpride; Drug: bromocriptine; Drug: Placebo
Healthy Controls, Scan1: Bromocriptine; Scan2: Amisulpride; Scan3: Placebo	Experimental	Individuals in the healthy control group were randomized to the following scan order. Participants were administered a study medication or placebo 3 hours prior to the start of the scan. The participant did not know what study medication they received for each scan: Scan 1: Bromocriptine (single dose, 1.25 mg, 3 hours pre-scan) Scan 2: Amisulpride (single dose, 400 mg, 3 hours pre-scan) Scan 3: Placebo(single dose, 3 hours pre-scan) Receives: Drug: amisulpride; Drug: bromocriptine; Drug: Placebo
Anorexia Nervosa, Scan1: Placebo; Scan2: Amisulpride; Scan3: Bromocriptine	Experimental	Individuals in the anorexia nervosa group were randomized to the following scan order. Participants were administered a study medication or placebo 3 hours prior to the start of the scan. The participant did not know what study medication they received for each scan: Scan 1: Placebo(single dose, 3 hours pre-scan) Scan 2: Amisulpride (single dose, 400 mg, 3 hours pre-scan) Scan 3: Bromocriptine (single dose, 1.25 mg, 3 hours pre-scan) Receives: Drug: amisulpride; Drug: bromocriptine; Drug: Placebo
Anorexia Nervosa, Scan1: Placebo; Scan2: Bromocriptine; Scan3: Amisulpride;	Experimental	Individuals in the anorexia nervosa group were randomized to the following scan order. Participants were administered a study medication or placebo 3 hours prior to the start of the scan. The participant did not know what study medication they received for each scan: Scan 1: Placebo(single dose, 3 hours pre-scan) Scan 2: Bromocriptine (single dose, 1.25 mg, 3 hours pre-scan) Scan 3: Amisulpride (single dose, 400 mg, 3 hours pre-scan) Receives: Drug: amisulpride; Drug: bromocriptine; Drug: Placebo
Anorexia Nervosa, Scan1: Amisulpride; Scan2: Placebo; Scan3: Bromocriptine	Experimental	Individuals in the anorexia nervosa group were randomized to the following scan order. Participants were administered a study medication or placebo 3 hours prior to the start of the scan. The participant did not know what study medication they received for each scan: Scan 1: Amisulpride (single dose, 400 mg, 3 hours pre-scan) Scan 2: Placebo(single dose, 3 hours pre-scan) Scan 3: Bromocriptine (single dose, 1.25 mg, 3 hours pre-scan) Receives: Drug: amisulpride; Drug: bromocriptine; Drug: Placebo
Anorexia Nervosa, Scan1: Amisulpride; Scan2: Bromocriptine; Scan1: Placebo	Experimental	Individuals in the anorexia nervosa group were randomized to the following scan order. Participants were administered a study medication or placebo 3 hours prior to the start of the scan. The participant did not know what study medication they received for each scan: Scan 1: Amisulpride (single dose, 400 mg, 3 hours pre-scan) Scan 2: Bromocriptine (single dose, 1.25 mg, 3 hours pre-scan) Scan 3: Placebo(single dose, 3 hours pre-scan) Receives: Drug: amisulpride; Drug: bromocriptine; Drug: Placebo
Anorexia Nervosa, Scan1: Bromocriptine; Scan2: Placebo; Scan 3: Amisulpride	Experimental	Individuals in the anorexia nervosa group were randomized to the following scan order. Participants were administered a study medication or placebo 3 hours prior to the start of the scan. The participant did not know what study medication they received for each scan: Scan 1: Bromocriptine (single dose, 1.25 mg, 3 hours pre-scan) Scan 2: Placebo(single dose, 3 hours pre-scan) Scan 3: Amisulpride (single dose, 400 mg, 3 hours pre-scan) Receives: Drug: amisulpride; Drug: bromocriptine; Drug: Placebo
Anorexia Nervosa, Scan1: Bromocriptine; Scan2: Amisulpride; Scan3: Placebo	Experimental	Individuals in the anorexia nervosa group were randomized to the following scan order. Participants were administered a study medication or placebo 3 hours prior to the start of the scan. The participant did not know what study medication they received for each scan: Scan 1: Bromocriptine (single dose, 1.25 mg, 3 hours pre-scan) Scan 2: Amisulpride (single dose, 400 mg, 3 hours pre-scan) Scan 3: Placebo(single dose, 3 hours pre-scan) Receives: Drug: amisulpride; Drug: bromocriptine; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Measurement of Brain Activation (Measured in Percent Signal Change) During a Prediction Error Taste Reward Task Using Functional Magnetic Resonance Imaging (fMRI).
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 taste, or no solution. 20 percent of stimulus receipt was unexpected, that is there is a mismatch between expectation and outcome. Using a region of interest (ROI)-based approach, brain activation percent signal change values were extracted from the brain images for each subject and compared across groups and medication scans. A repeated measures ANOVA was used to calculate the mean brain activation for each group and each medication scan.
Measured: The outcome measure was assessed during the taste MRI task on each of the 3 intervention scan days over the course of 9 to 12 days
Measurement of Brain Activation (Measured in Percent Signal Change) During Taste Stimulus Expectation Using Functional Magnetic Resonance Imaging (fMRI).
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 taste, or no solution. Using a region of interest (ROI)-based approach, brain activation percent signal change values were extracted from the brain images for each subject and compared across groups and medication scans. Here only stimulus expectation data were analyzed. A repeated measures ANOVA was used to calculate the mean brain activation for each group and each medication scan.
Measured: The outcome measure was assessed during the taste MRI task on each of the 3 intervention scan days over the course of 9 to 12 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Oct 20201 Jan 2025

First posted16 Oct 2019
Study start20 Oct 2020
Primary completion6 Sep 2023
Study completion1 Jan 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Anorexia NervosaStudies of the same condition, open and under way.
More trials run by University of California, San DiegoThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Early Phase 1
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Model description: There are two groups in this study, healthy controls and anorexia nervosa. Each group completes 3 MRI scans where one of the following medications are administered 3 hours prior to the start of the scan: placebo, amisulpride, bromocriptine. The order of the medication scans was randomized.
Masking: Single blind
Who is masked: Participant
Enrolment: 31 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04128683
Sponsor's protocol ID: 191348
Other IDs: 5R21MH120475
Status last verified: Mar 2025
First submitted: 14 Oct 2019
Last updated: 11 Apr 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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RecruitingObservational study
Speech Groups for Children Living With a Sibling Who Suffers From Anorexia Nervosa
Anorexia Nervosa
Enrolling by invitation
Sleep and Activity For Eating Disorders
Eating Disorders, Anorexia Nervosa
Not yet recruitingObservational study
Biomarkers in EV Associated With Marrow Adiposity in Anorexia
Anorexia Nervosa Restricting Type, Anorexia Nervosa (DSM-IV Revised Criteria)
Active, not recruiting
Targeting Social Function in Anxiety and Eating Disorders
Eating Disorders, Anorexia Nervosa

All Anorexia Nervosa trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Toward Understanding Dopamine Receptor Contributions to Prediction Error and Reversal Learning in Anorexia Nervosa
ClinicalTrials.gov ID: NCT04128683
Acronym / sponsor ID: 191348
Conditions: Anorexia Nervosa
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 31 participants (actual)
Lead sponsor: University of California, San DiegoUniversity, hospital or other
Collaborators: National Institute of Mental Health (NIMH)
Study start: 20 Oct 2020 (actual)
Primary completion: 6 Sep 2023 (actual)
Study completion: 1 Jan 2025 (actual)
First posted: 16 Oct 2019 (actual)
Results: Posted 11 Apr 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Research in AN showed repeatedly altered PE processing suggesting altered dopamine circuit function in the disorder.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 12
Model description: There are two groups in this study, healthy controls and anorexia nervosa. Each group completes 3 MRI scans where one of the following medications are administered 3 hours prior to the start of the scan: placebo, amisulpride, bromocriptine. The order of the medication scans was randomized.

Arm	Type	Receives
Healthy Controls, Scan1: Placebo; Scan2: Amisulpride; Scan3: Bromocriptine	Experimental	Drug: amisulpride, Drug: bromocriptine, Drug: PlaceboIndividuals in the healthy control group were randomized to the following scan order. Participants were administered a study medication or placebo 3 hours prior to the start of the scan. The participant did not know what study medication they received for each scan: Scan 1: Placebo(single dose, 3 hours pre-scan) Scan 2: Amisulpride (single dose, 400 mg, 3 hours pre-scan) Scan 3: Bromocriptine (single dose, 1.25 mg, 3 hours pre-scan)
Healthy Controls, Scan1: Placebo; Scan2: Bromocriptine; Scan3: Amisulpride;	Experimental	Drug: amisulpride, Drug: bromocriptine, Drug: PlaceboIndividuals in the healthy control group were randomized to the following scan order. Participants were administered a study medication or placebo 3 hours prior to the start of the scan. The participant did not know what study medication they received for each scan: Scan 1: Placebo(single dose, 3 hours pre-scan) Scan 2: Bromocriptine (single dose, 1.25 mg, 3 hours pre-scan) Scan 3: Amisulpride (single dose, 400 mg, 3 hours pre-scan)
Healthy Controls, Scan1: Amisulpride; Scan2: Placebo; Scan3: Bromocriptine	Experimental	Drug: amisulpride, Drug: bromocriptine, Drug: PlaceboIndividuals in the healthy control group were randomized to the following scan order. Participants were administered a study medication or placebo 3 hours prior to the start of the scan. The participant did not know what study medication they received for each scan: Scan 1: Amisulpride (single dose, 400 mg, 3 hours pre-scan) Scan 2: Placebo(single dose, 3 hours pre-scan) Scan 3: Bromocriptine (single dose, 1.25 mg, 3 hours pre-scan)
Healthy Controls, Scan1: Amisulpride; Scan2: Bromocriptine; Scan1: Placebo	Experimental	Drug: amisulpride, Drug: bromocriptine, Drug: PlaceboIndividuals in the healthy control group were randomized to the following scan order. Participants were administered a study medication or placebo 3 hours prior to the start of the scan. The participant did not know what study medication they received for each scan: Scan 1: Amisulpride (single dose, 400 mg, 3 hours pre-scan) Scan 2: Bromocriptine (single dose, 1.25 mg, 3 hours pre-scan) Scan 3: Placebo(single dose, 3 hours pre-scan)
Healthy Controls, Scan1: Bromocriptine; Scan2: Placebo; Scan 3: Amisulpride	Experimental	Drug: amisulpride, Drug: bromocriptine, Drug: PlaceboIndividuals in the healthy control group were randomized to the following scan order. Participants were administered a study medication or placebo 3 hours prior to the start of the scan. The participant did not know what study medication they received for each scan: Scan 1: Bromocriptine (single dose, 1.25 mg, 3 hours pre-scan) Scan 2: Placebo(single dose, 3 hours pre-scan) Scan 3: Amisulpride (single dose, 400 mg, 3 hours pre-scan)
Healthy Controls, Scan1: Bromocriptine; Scan2: Amisulpride; Scan3: Placebo	Experimental	Drug: amisulpride, Drug: bromocriptine, Drug: PlaceboIndividuals in the healthy control group were randomized to the following scan order. Participants were administered a study medication or placebo 3 hours prior to the start of the scan. The participant did not know what study medication they received for each scan: Scan 1: Bromocriptine (single dose, 1.25 mg, 3 hours pre-scan) Scan 2: Amisulpride (single dose, 400 mg, 3 hours pre-scan) Scan 3: Placebo(single dose, 3 hours pre-scan)
Anorexia Nervosa, Scan1: Placebo; Scan2: Amisulpride; Scan3: Bromocriptine	Experimental	Drug: amisulpride, Drug: bromocriptine, Drug: PlaceboIndividuals in the anorexia nervosa group were randomized to the following scan order. Participants were administered a study medication or placebo 3 hours prior to the start of the scan. The participant did not know what study medication they received for each scan: Scan 1: Placebo(single dose, 3 hours pre-scan) Scan 2: Amisulpride (single dose, 400 mg, 3 hours pre-scan) Scan 3: Bromocriptine (single dose, 1.25 mg, 3 hours pre-scan)
Anorexia Nervosa, Scan1: Placebo; Scan2: Bromocriptine; Scan3: Amisulpride;	Experimental	Drug: amisulpride, Drug: bromocriptine, Drug: PlaceboIndividuals in the anorexia nervosa group were randomized to the following scan order. Participants were administered a study medication or placebo 3 hours prior to the start of the scan. The participant did not know what study medication they received for each scan: Scan 1: Placebo(single dose, 3 hours pre-scan) Scan 2: Bromocriptine (single dose, 1.25 mg, 3 hours pre-scan) Scan 3: Amisulpride (single dose, 400 mg, 3 hours pre-scan)
Anorexia Nervosa, Scan1: Amisulpride; Scan2: Placebo; Scan3: Bromocriptine	Experimental	Drug: amisulpride, Drug: bromocriptine, Drug: PlaceboIndividuals in the anorexia nervosa group were randomized to the following scan order. Participants were administered a study medication or placebo 3 hours prior to the start of the scan. The participant did not know what study medication they received for each scan: Scan 1: Amisulpride (single dose, 400 mg, 3 hours pre-scan) Scan 2: Placebo(single dose, 3 hours pre-scan) Scan 3: Bromocriptine (single dose, 1.25 mg, 3 hours pre-scan)
Anorexia Nervosa, Scan1: Amisulpride; Scan2: Bromocriptine; Scan1: Placebo	Experimental	Drug: amisulpride, Drug: bromocriptine, Drug: PlaceboIndividuals in the anorexia nervosa group were randomized to the following scan order. Participants were administered a study medication or placebo 3 hours prior to the start of the scan. The participant did not know what study medication they received for each scan: Scan 1: Amisulpride (single dose, 400 mg, 3 hours pre-scan) Scan 2: Bromocriptine (single dose, 1.25 mg, 3 hours pre-scan) Scan 3: Placebo(single dose, 3 hours pre-scan)
Anorexia Nervosa, Scan1: Bromocriptine; Scan2: Placebo; Scan 3: Amisulpride	Experimental	Drug: amisulpride, Drug: bromocriptine, Drug: PlaceboIndividuals in the anorexia nervosa group were randomized to the following scan order. Participants were administered a study medication or placebo 3 hours prior to the start of the scan. The participant did not know what study medication they received for each scan: Scan 1: Bromocriptine (single dose, 1.25 mg, 3 hours pre-scan) Scan 2: Placebo(single dose, 3 hours pre-scan) Scan 3: Amisulpride (single dose, 400 mg, 3 hours pre-scan)
Anorexia Nervosa, Scan1: Bromocriptine; Scan2: Amisulpride; Scan3: Placebo	Experimental	Drug: amisulpride, Drug: bromocriptine, Drug: PlaceboIndividuals in the anorexia nervosa group were randomized to the following scan order. Participants were administered a study medication or placebo 3 hours prior to the start of the scan. The participant did not know what study medication they received for each scan: Scan 1: Bromocriptine (single dose, 1.25 mg, 3 hours pre-scan) Scan 2: Amisulpride (single dose, 400 mg, 3 hours pre-scan) Scan 3: Placebo(single dose, 3 hours pre-scan)

Who may qualify

Ages: 18 to 29 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (13 listed)

Healthy Controls
Females ages 18-29 years
Healthy body weight between 90 and 110 % average body weight since puberty.
Regular monthly menstrual cycle
Edinburgh Handedness Inventory Revised (EHI-R) LQ* score > +200

Key exclusion criteria (31 listed)

Healthy Controls
Current pregnancy or breast feeding within last 3 months
Illiterate/Blind individuals
First degree relative with current or past eating disorder
Current Medications other than BCP or IUD

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
amisulprideAlso: SolianDopamine D2 antagonist to test how it affects brain response and behavior to prediction error and reversal tasks during functional magnetic resonance imaging (fMRI).	Drug	Anorexia Nervosa, Scan1: Amisulpride; Scan2: Bromocriptine; Scan1: Placebo, Anorexia Nervosa, Scan1: Amisulpride; Scan2: Placebo; Scan3: Bromocriptine, Anorexia Nervosa, Scan1: Bromocriptine; Scan2: Amisulpride; Scan3: Placebo, Anorexia Nervosa, Scan1: Bromocriptine; Scan2: Placebo; Scan 3: Amisulpride, Anorexia Nervosa, Scan1: Placebo; Scan2: Amisulpride; Scan3: Bromocriptine, Anorexia Nervosa, Scan1: Placebo; Scan2: Bromocriptine; Scan3: Amisulpride;, Healthy Controls, Scan1: Amisulpride; Scan2: Bromocriptine; Scan1: Placebo, Healthy Controls, Scan1: Amisulpride; Scan2: Placebo; Scan3: Bromocriptine, Healthy Controls, Scan1: Bromocriptine; Scan2: Amisulpride; Scan3: Placebo, Healthy Controls, Scan1: Bromocriptine; Scan2: Placebo; Scan 3: Amisulpride, Healthy Controls, Scan1: Placebo; Scan2: Amisulpride; Scan3: Bromocriptine, Healthy Controls, Scan1: Placebo; Scan2: Bromocriptine; Scan3: Amisulpride;
bromocriptineAlso: ParlodelDopamine D2 receptor agonist test how it affects brain response and behavior to prediction error and reversal tasks during functional magnetic resonance imaging (fMRI).	Drug	Anorexia Nervosa, Scan1: Amisulpride; Scan2: Bromocriptine; Scan1: Placebo, Anorexia Nervosa, Scan1: Amisulpride; Scan2: Placebo; Scan3: Bromocriptine, Anorexia Nervosa, Scan1: Bromocriptine; Scan2: Amisulpride; Scan3: Placebo, Anorexia Nervosa, Scan1: Bromocriptine; Scan2: Placebo; Scan 3: Amisulpride, Anorexia Nervosa, Scan1: Placebo; Scan2: Amisulpride; Scan3: Bromocriptine, Anorexia Nervosa, Scan1: Placebo; Scan2: Bromocriptine; Scan3: Amisulpride;, Healthy Controls, Scan1: Amisulpride; Scan2: Bromocriptine; Scan1: Placebo, Healthy Controls, Scan1: Amisulpride; Scan2: Placebo; Scan3: Bromocriptine, Healthy Controls, Scan1: Bromocriptine; Scan2: Amisulpride; Scan3: Placebo, Healthy Controls, Scan1: Bromocriptine; Scan2: Placebo; Scan 3: Amisulpride, Healthy Controls, Scan1: Placebo; Scan2: Amisulpride; Scan3: Bromocriptine, Healthy Controls, Scan1: Placebo; Scan2: Bromocriptine; Scan3: Amisulpride;
PlaceboPlacebo pill with no active drug ingredients	Drug	Anorexia Nervosa, Scan1: Amisulpride; Scan2: Bromocriptine; Scan1: Placebo, Anorexia Nervosa, Scan1: Amisulpride; Scan2: Placebo; Scan3: Bromocriptine, Anorexia Nervosa, Scan1: Bromocriptine; Scan2: Amisulpride; Scan3: Placebo, Anorexia Nervosa, Scan1: Bromocriptine; Scan2: Placebo; Scan 3: Amisulpride, Anorexia Nervosa, Scan1: Placebo; Scan2: Amisulpride; Scan3: Bromocriptine, Anorexia Nervosa, Scan1: Placebo; Scan2: Bromocriptine; Scan3: Amisulpride;, Healthy Controls, Scan1: Amisulpride; Scan2: Bromocriptine; Scan1: Placebo, Healthy Controls, Scan1: Amisulpride; Scan2: Placebo; Scan3: Bromocriptine, Healthy Controls, Scan1: Bromocriptine; Scan2: Amisulpride; Scan3: Placebo, Healthy Controls, Scan1: Bromocriptine; Scan2: Placebo; Scan 3: Amisulpride, Healthy Controls, Scan1: Placebo; Scan2: Amisulpride; Scan3: Bromocriptine, Healthy Controls, Scan1: Placebo; Scan2: Bromocriptine; Scan3: Amisulpride;

Primary outcome

Measurement of Brain Activation (Measured in Percent Signal Change) During a Prediction Error Taste Reward Task Using Functional Magnetic Resonance Imaging (fMRI).
Time frame: The outcome measure was assessed during the taste MRI task on each of the 3 intervention scan days over the course of 9 to 12 days
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 taste, or no solution. 20 percent of stimulus receipt was unexpected, that is there is a mismatch between expectation and outcome. Using a region of interest (ROI)-based approach, brain activation percent signal change values were extracted from the brain images for each subject and compared across groups and medication scans. A repeated measures ANOVA was used to calculate the mean brain activation for each group and each medication scan.
Measurement of Brain Activation (Measured in Percent Signal Change) During Taste Stimulus Expectation Using Functional Magnetic Resonance Imaging (fMRI).
Time frame: The outcome measure was assessed during the taste MRI task on each of the 3 intervention scan days over the course of 9 to 12 days
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 taste, or no solution. Using a region of interest (ROI)-based approach, brain activation percent signal change values were extracted from the brain images for each subject and compared across groups and medication scans. Here only stimulus expectation data were analyzed. A repeated measures ANOVA was used to calculate the mean brain activation for each group and each medication scan.

Results and safety

Results posted to the registry on 11 Apr 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Healthy Controls	7	7
Anorexia Nervosa	6	6

Primary outcome: Measurement of Brain Activation (Measured in Percent Signal Change) During a Prediction Error Taste Reward Task Using Functional Magnetic Resonance Imaging (fMRI).

Time frame: The outcome measure was assessed during the taste MRI task on each of the 3 intervention scan days over the course of 9 to 12 days. Mean (Standard Error). Unit: Percent Signal Change

Measure	Healthy Controls Placebo Scan n = 7	Anorexia Nervosa Placebo Scan n = 5	Healthy Controls Amisulpride Medication Scan n = 7	Anorexia Nervosa Amisulpride Medication Scan n = 5	Healthy Controls Bromocriptine Medication Scan n = 7	Anorexia Nervosa Bromocriptine Medication Scan n = 5
Left Ventral Insula Brain Activation	5.847 (1.349)	5.083 (1.596)	0.991 (0.938)	-1.047 (1.109)	1.116 (1.225)	-0.148 (1.450)
Right Ventral Insula Brain Activation	4.095 (0.669)	4.860 (0.791)	0.883 (0.716)	-0.137 (0.847)	4.117 (0.987)	2.650 (1.167)
Left Ventral Striatum Brain Activation	2.081 (0.582)	1.767 (0.689)	1.475 (1.153)	-0.599 (1.365)	1.122 (0.951)	1.328 (1.126)
Right Ventral Striatum Brain Activation	1.583 (0.660)	2.367 (0.781)	1.728 (1.020)	-0.799 (1.207)	1.642 (0.304)	1.732 (0.359)
Left Inferior Orbital Frontal Cortex Brain Activation	-0.199 (0.789)	0.544 (0.934)	0.988 (0.686)	-1.222 (0.811)	0.646 (1.038)	1.171 (1.229)
Right Inferior Orbital Frontal Cortex Brain Activation	4.333 (0.427)	4.138 (0.505)	0.396 (0.803)	-0.699 (0.950)	5.512 (1.244)	4.774 (1.472)

Population analysed: brain imaging data was pre-processed and brain response was analyzed across groups (healthy control group versus anorexia nervosa group) and within group for each medication. One participant in the anorexia nervosa group had to be excluded from the analysis results due to excessive movement throughout the MRI scan.

Primary outcome: Measurement of Brain Activation (Measured in Percent Signal Change) During Taste Stimulus Expectation Using Functional Magnetic Resonance Imaging (fMRI).

Time frame: The outcome measure was assessed during the taste MRI task on each of the 3 intervention scan days over the course of 9 to 12 days. Mean (Standard Error). Unit: Percent Signal Change

Measure	Healthy Controls Placebo Scan n = 7	Anorexia Nervosa Placebo Scan n = 5	Healthy Controls Bromocriptine Medication Scan n = 7	Anorexia Nervosa Bromocriptine Medication Scan n = 5	Healthy Controls Amisulpride Medication Scan n = 7	Anorexia Nervosa Amisulpride Medication Scan n = 5
Left Ventral Insula Brain Activation	4.799 (0.681)	3.282 (0.806)	4.821 (1.481)	5.569 (1.752)	5.265 (0.803)	4.691 (0.950)
Right Ventral Insula Brain Activation	3.884 (0.526)	3.015 (0.622)	4.436 (2.406)	5.866 (2.847)	3.464 (0.725)	3.383 (0.858)
Left Ventral Striatum Brain Activation	1.558 (0.347)	1.790 (0.411)	3.450 (1.174)	2.860 (1.390)	1.206 (0.390)	1.738 (0.461)
Right Ventral Striatum Brain Activation	1.717 (0.381)	1.501 (0.451)	4.700 (1.459)	3.208 (1.727)	2.163 (0.758)	1.609 (0.897)
Left Inferior Orbital Frontal Cortex Brain Activation	3.649 (0.480)	2.259 (0.569)	3.838 (2.061)	6.392 (2.439)	3.562 (0.996)	4.722 (1.178)
Right Inferior Orbital Frontal Cortex Brain Activation	4.193 (0.782)	3.352 (0.926)	4.745 (1.758)	5.712 (2.080)	5.362 (1.130)	4.226 (1.337)

Population analysed: brain imaging data was pre-processed and brain response was analyzed across groups (healthy control group versus anorexia nervosa group) and within group for each medication

Adverse events

Time frame: Adverse events were monitored/assessed from the administration of the medication on scan 1 (1st intervention) through the end of scan 3 (3rd intervention). The time period was 9 to 12 days depending on length of each washout period.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Healthy Control Group Placebo Scan	0 of 7 (0%)	0 of 7 (0%)	0 of 7
Anorexia Nervosa Group Placebo Scan	0 of 6 (0%)	0 of 6 (0%)	0 of 6
Healthy Control Group Amisulpride Scan	0 of 7 (0%)	0 of 7 (0%)	0 of 7
Anorexia Nervosa Group Amisulpride Scan	0 of 6 (0%)	0 of 6 (0%)	0 of 6
Healthy Control Group Bromocriptine Scan	0 of 7 (0%)	2 of 7 (28.6%)	0 of 7
Anorexia Nervosa Group Bromocriptine Scan	0 of 6 (0%)	0 of 6 (0%)	0 of 6

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Guido Frank, MD principal investigator

University of California, San Diego

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing amisulpride and bromocriptine in people with Anorexia Nervosa, run by University of California, San Diego at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Measurement of Brain Activation (Measured in Percent Signal Change) During a Prediction Error Taste Reward Task Using Functional Magnetic Resonance Imaging (fMRI). (time frame: The outcome measure was assessed during the taste MRI task on each of the 3 intervention scan days over the course of 9 to 12 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04128683.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2025.