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Atypical Antipsychotic

Bromocriptine + Amisulpride for Anorexia Nervosa

Q: What medical conditions is bromocriptine typically prescribed to treat?

Bromocriptine can be leveraged to treat neuroleptic malignant syndrome (NMS), <a href="https://www.withpower.com/clinical-trials/schizophrenia">schizophrenia</a>, and mental retardation.

Q: Is this research endeavor currently in pursuit of new participants?

Confirmed, the clinicaltrial.gov registry states that this medical data is presently conducting its recruitment process. The study's initial posting was on October 20th 2020 and it last received an update September 28th 2022. 44 participants are required to be enrolled from a single trial site.

Q: How many individuals have registered to participate in the research project?

Correct. Evident on clinicaltrials.gov, this ongoing study is recruiting patients at one site for an enrollment total of 44 individuals. The posting date was October 20th 2020 and the most recent update was September 28th 2022.

Q: Does the study include patients aged 80 or over?

This trial is available to any individuals aged 18-29.

Q: Is it possible for me to enrol in this research initiative?

This clinical trial seeks 44 participants aged between 18 and 29 who have been diagnosed with anorexia nervosa. To be eligible, they must meet the following prerequisites: completing a one to two-week program at either The University of <a href="https://www.withpower.com/clinical-trials/california">California</a> San Diego Eating Disorders Center for Treatment and Research or Rady Children's Hospital San Diego Medical Behavioral Unit., suffering from restricting subtype without any binge/purge behaviour, having a healthy body weight in the range of 90% - 110 % average body weight since puberty,, Edinburgh Handedness Inventory Revised (EHI-R) LQ* score above +200, meeting diagnostic criteria for AN such

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

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ immediate during brain scanning

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

fMRI brain response within group across the three conditions and distinction between conditions within groups

Secondary outcome measures

Difference in brain response between groups

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of California, San DiegoLead Sponsor

1,121 Previous Clinical Trials

1,521,394 Total Patients Enrolled

15 Trials studying Anorexia Nervosa

1,583 Patients Enrolled for Anorexia Nervosa

Guido Frank, MDPrincipal Investigator - University of California, San Diego

University of California, San Diego

5 Previous Clinical Trials

444 Total Patients Enrolled

5 Trials studying Anorexia Nervosa

444 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What medical conditions is bromocriptine typically prescribed to treat?

"Bromocriptine can be leveraged to treat neuroleptic malignant syndrome (NMS), schizophrenia, and mental retardation."

Answered by AI

Is this research endeavor currently in pursuit of new participants?

"Confirmed, the clinicaltrial.gov registry states that this medical data is presently conducting its recruitment process. The study's initial posting was on October 20th 2020 and it last received an update September 28th 2022. 44 participants are required to be enrolled from a single trial site."

Answered by AI

How many individuals have registered to participate in the research project?

"Correct. Evident on clinicaltrials.gov, this ongoing study is recruiting patients at one site for an enrollment total of 44 individuals. The posting date was October 20th 2020 and the most recent update was September 28th 2022."

Answered by AI

Does the study include patients aged 80 or over?

"This trial is available to any individuals aged 18-29."

Answered by AI

Is it possible for me to enrol in this research initiative?

"This clinical trial seeks 44 participants aged between 18 and 29 who have been diagnosed with anorexia nervosa. To be eligible, they must meet the following prerequisites: completing a one to two-week program at either The University of California San Diego Eating Disorders Center for Treatment and Research or Rady Children's Hospital San Diego Medical Behavioral Unit., suffering from restricting subtype without any binge/purge behaviour, having a healthy body weight in the range of 90% - 110 % average body weight since puberty,, Edinburgh Handedness Inventory Revised (EHI-R) LQ* score above +200, meeting diagnostic criteria for AN such"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Guido Frank 2020. "Dopamine Receptor Contributions to Prediction Error and Reversal Learning in Anorexia Nervosa". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04128683.

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