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Atypical Antipsychotic

Bromocriptine + Amisulpride for Anorexia Nervosa

Phase < 1
Waitlist Available
Led By Guido Frank, MD
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up immediate during brain scanning
Awards & highlights
Approved for 5 Other Conditions
No Placebo-Only Group
All Individual Drugs Already Approved

Summary

This trial will use fMRI to study how different doses of the dopamine agonist, Cabergoline, might impact food-related reward processing and AN symptoms.

Who is the study for?
This trial is for females aged 18-29 with Anorexia Nervosa (AN), specifically the restricting type without binge/purge behaviors. Participants must be underweight with a BMI below 17.5, have a fear of weight gain, body image distortion, and no menstrual cycle for three months. They should speak English as their primary language and be in the first weeks of treatment at specified centers.
What is being tested?
The study tests how two drugs, bromocriptine and amisulpride, affect dopamine receptors related to reward processing in AN patients. It aims to understand if these medications can improve prediction error responses and reversal learning deficits observed in AN.
What are the potential side effects?
Potential side effects from bromocriptine or amisulpride may include nausea, headaches, dizziness, low blood pressure, sleepiness or insomnia. There might also be risks of hormonal changes since both drugs interact with dopamine pathways.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediate during brain scanning
This trial's timeline: 3 weeks for screening, Varies for treatment, and immediate during brain scanning for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
fMRI brain response within group across the three conditions and distinction between conditions within groups
Secondary study objectives
Difference in brain response between groups

Awards & Highlights

Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Healthy ControlsExperimental Treatment2 Interventions
Healthy Control Subjects
Group II: Anorexia NervosaExperimental Treatment2 Interventions
Anorexia Nervosa Subjects
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Amisulpride
FDA approved

Find a Location

Who is running the clinical trial?

University of California, San DiegoLead Sponsor
1,180 Previous Clinical Trials
1,575,015 Total Patients Enrolled
18 Trials studying Anorexia Nervosa
1,874 Patients Enrolled for Anorexia Nervosa
Guido Frank, MDPrincipal Investigator - University of California, San Diego
University of California, San Diego
5 Previous Clinical Trials
447 Total Patients Enrolled
5 Trials studying Anorexia Nervosa
447 Patients Enrolled for Anorexia Nervosa

Media Library

Amisulpride (Atypical Antipsychotic) Clinical Trial Eligibility Overview. Trial Name: NCT04128683 — Phase < 1
Anorexia Nervosa Research Study Groups: Healthy Controls, Anorexia Nervosa
Anorexia Nervosa Clinical Trial 2023: Amisulpride Highlights & Side Effects. Trial Name: NCT04128683 — Phase < 1
Amisulpride (Atypical Antipsychotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04128683 — Phase < 1
~6 spots leftby Nov 2025
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