Status:
COMPLETED
Dopamine Receptor Contributions to Prediction Error and Reversal Learning in Anorexia Nervosa
Lead Sponsor:
University of California, San Diego
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Anorexia Nervosa
Eligibility:
FEMALE
18-29 years
Phase:
EARLY_PHASE1
Brief 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; howeve...
Eligibility Criteria
Inclusion
- 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
- 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
Exclusion
- 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
- 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)
Key Trial Info
Start Date :
October 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2025
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT04128683
Start Date
October 20 2020
End Date
January 1 2025
Last Update
April 11 2025
Active Locations (1)
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1
University of California San Diego
San Diego, California, United States, 92121