Bromocriptine + Amisulpride for Anorexia Nervosa

Recruiting in Palo Alto (17 mi)

Overseen byGuido Frank, MD

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

Sponsor: University of California, San Diego

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Guido Frank, MD

Principal Investigator

University of California, San Diego

Eligibility Criteria

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.

Inclusion Criteria

I am a healthy female, aged 18-29, with a stable weight and regular periods. I primarily speak English and am right-handed.

I am a woman aged 18-29, underweight with a BMI below 17.5, fear gaining weight, have body image issues, missed periods for over 3 months, don't binge or purge, am right-handed with an EHI-R score over +200, and speak English.

Exclusion Criteria

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, use of anti-psychotic or other dopamine acting medication within the past week at time of MRI, recent history of substance abuse or dependence, major medical illness, metal implants or braces

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, past or present Axis I psychiatric disorder, major medical illness, recent history of suspected substance abuse or lifetime history of psychostimulant abuse and/or dependence, metal implants or braces

Treatment Details

Interventions

Amisulpride (Atypical Antipsychotic)
Bromocriptine (Dopamine Agonist)

Trial OverviewThe 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.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Healthy ControlsExperimental Treatment2 Interventions

Healthy Control Subjects

Group II: Anorexia NervosaExperimental Treatment2 Interventions

Anorexia Nervosa Subjects