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

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

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04128683
Enrollment
31
Registered
2019-10-16
Start date
2020-10-20
Completion date
2025-01-01
Last updated
2025-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anorexia Nervosa

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; 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.

Interventions

DRUGamisulpride

Dopamine D2 antagonist to test how it affects brain response and behavior to prediction error and reversal tasks during functional magnetic resonance imaging (fMRI).

DRUGbromocriptine

Dopamine D2 receptor agonist test how it affects brain response and behavior to prediction error and reversal tasks during functional magnetic resonance imaging (fMRI).

DRUGPlacebo

Placebo pill with no active drug ingredients

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
University of California, San Diego
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Subject)

Masking description

The participant did not know what medication they were receiving on each scan day.

Intervention 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.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 29 Years
Healthy volunteers
Yes

Inclusion criteria

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 criteria

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)

Design outcomes

Primary

MeasureTime frameDescription
Measurement of Brain Activation (Measured in Percent Signal Change) During a Prediction Error Taste Reward Task Using Functional Magnetic Resonance Imaging (fMRI).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 daysThis 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).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 daysStudy 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.

Countries

United States

Participant flow

Recruitment details

31 individuals were recruited and enrolled in the study between 10/20/2020 and 6/22/2023 from the San Diego community and the UC San Diego Health Eating Disorders Center for Treatment and Research. Subjects completed several screening processes to determine eligibility and after eligibility was confirmed, were randomly assigned to the study arms. Of those not randomized, 18 individuals were excluded (10 screen failures, 1 voluntary withdrawal by subject, and 7 withdrawals by PI).

Pre-assignment details

Of the 31 subjects enrolled, 13 subjects were randomized, 7 participants in the healthy control group and 6 participants in the anorexia nervosa group. Each subject was assigned randomly to one of the 6 study arms. These study arms had different orders of the medication intervention administered at each scan. All subjects received each of the 3 study interventions (amysulpride, bromocriptine, placebo), however, the order of medication intervention at each scan varied based on the randomization.

Participants by arm

ArmCount
Healthy Controls
Subjects at normal weight without psychiatric or eating disorder history
7
Anorexia Nervosa
Subjects diagnosed with restricting-type anorexia nervosa according to DSM-V criteria
6
Total13

Baseline characteristics

CharacteristicHealthy ControlsAnorexia NervosaTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
7 Participants6 Participants13 Participants
Age, Continuous24.09 Years
STANDARD_DEVIATION 4.02
21.43 Years
STANDARD_DEVIATION 2.25
22.86 Years
STANDARD_DEVIATION 3.47
Body Mass Index22.41 kg/m^2
STANDARD_DEVIATION 1.69
18.63 kg/m^2
STANDARD_DEVIATION 0.94
20.67 kg/m^2
STANDARD_DEVIATION 2.38
Eating Disorder Inventory 3 - Body Dissatisfaction Subscale5.00 units on a scale
STANDARD_DEVIATION 3.78
30.33 units on a scale
STANDARD_DEVIATION 4.76
16.69 units on a scale
STANDARD_DEVIATION 13.76
Eating Disorder Inventory 3 - Drive for Thinness Subscale0.57 units on a scale
STANDARD_DEVIATION 0.79
19.5 units on a scale
STANDARD_DEVIATION 4.41
9.30 units on a scale
STANDARD_DEVIATION 10.24
Eating Disorders Examination Questionnaire Global Score0.33 units on a scale
STANDARD_DEVIATION 0.41
3.62 units on a scale
STANDARD_DEVIATION 0.88
1.85 units on a scale
STANDARD_DEVIATION 1.8
Ethnicity (NIH/OMB)
Hispanic or Latino
3 Participants2 Participants5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
4 Participants4 Participants8 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
2 Participants0 Participants2 Participants
Race (NIH/OMB)
Black or African American
1 Participants0 Participants1 Participants
Race (NIH/OMB)
More than one race
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants1 Participants1 Participants
Race (NIH/OMB)
White
4 Participants4 Participants8 Participants
Region of Enrollment
United States
7 Participants6 Participants13 Participants
Sex: Female, Male
Female
7 Participants6 Participants13 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
EG005
affected / at risk
deaths
Total, all-cause mortality
0 / 70 / 60 / 70 / 60 / 70 / 6
other
Total, other adverse events
0 / 70 / 60 / 70 / 62 / 70 / 6
serious
Total, serious adverse events
0 / 70 / 60 / 70 / 60 / 70 / 6

Outcome results

Primary

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.

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

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
Healthy Controls Placebo ScanMeasurement of Brain Activation (Measured in Percent Signal Change) During a Prediction Error Taste Reward Task Using Functional Magnetic Resonance Imaging (fMRI).Left Inferior Orbital Frontal Cortex Brain Activation-0.199 Percent Signal ChangeStandard Error 0.789
Healthy Controls Placebo ScanMeasurement of Brain Activation (Measured in Percent Signal Change) During a Prediction Error Taste Reward Task Using Functional Magnetic Resonance Imaging (fMRI).Right Ventral Insula Brain Activation4.095 Percent Signal ChangeStandard Error 0.669
Healthy Controls Placebo ScanMeasurement of Brain Activation (Measured in Percent Signal Change) During a Prediction Error Taste Reward Task Using Functional Magnetic Resonance Imaging (fMRI).Left Ventral Insula Brain Activation5.847 Percent Signal ChangeStandard Error 1.349
Healthy Controls Placebo ScanMeasurement of Brain Activation (Measured in Percent Signal Change) During a Prediction Error Taste Reward Task Using Functional Magnetic Resonance Imaging (fMRI).Right Inferior Orbital Frontal Cortex Brain Activation4.333 Percent Signal ChangeStandard Error 0.427
Healthy Controls Placebo ScanMeasurement of Brain Activation (Measured in Percent Signal Change) During a Prediction Error Taste Reward Task Using Functional Magnetic Resonance Imaging (fMRI).Left Ventral Striatum Brain Activation2.081 Percent Signal ChangeStandard Error 0.582
Healthy Controls Placebo ScanMeasurement of Brain Activation (Measured in Percent Signal Change) During a Prediction Error Taste Reward Task Using Functional Magnetic Resonance Imaging (fMRI).Right Ventral Striatum Brain Activation1.583 Percent Signal ChangeStandard Error 0.66
Anorexia Nervosa Placebo ScanMeasurement of Brain Activation (Measured in Percent Signal Change) During a Prediction Error Taste Reward Task Using Functional Magnetic Resonance Imaging (fMRI).Right Inferior Orbital Frontal Cortex Brain Activation4.138 Percent Signal ChangeStandard Error 0.505
Anorexia Nervosa Placebo ScanMeasurement of Brain Activation (Measured in Percent Signal Change) During a Prediction Error Taste Reward Task Using Functional Magnetic Resonance Imaging (fMRI).Right Ventral Insula Brain Activation4.860 Percent Signal ChangeStandard Error 0.791
Anorexia Nervosa Placebo ScanMeasurement of Brain Activation (Measured in Percent Signal Change) During a Prediction Error Taste Reward Task Using Functional Magnetic Resonance Imaging (fMRI).Left Ventral Insula Brain Activation5.083 Percent Signal ChangeStandard Error 1.596
Anorexia Nervosa Placebo ScanMeasurement of Brain Activation (Measured in Percent Signal Change) During a Prediction Error Taste Reward Task Using Functional Magnetic Resonance Imaging (fMRI).Left Inferior Orbital Frontal Cortex Brain Activation0.544 Percent Signal ChangeStandard Error 0.934
Anorexia Nervosa Placebo ScanMeasurement of Brain Activation (Measured in Percent Signal Change) During a Prediction Error Taste Reward Task Using Functional Magnetic Resonance Imaging (fMRI).Right Ventral Striatum Brain Activation2.367 Percent Signal ChangeStandard Error 0.781
Anorexia Nervosa Placebo ScanMeasurement of Brain Activation (Measured in Percent Signal Change) During a Prediction Error Taste Reward Task Using Functional Magnetic Resonance Imaging (fMRI).Left Ventral Striatum Brain Activation1.767 Percent Signal ChangeStandard Error 0.689
Healthy Controls Amisulpride Medication ScanMeasurement of Brain Activation (Measured in Percent Signal Change) During a Prediction Error Taste Reward Task Using Functional Magnetic Resonance Imaging (fMRI).Left Ventral Insula Brain Activation0.991 Percent Signal ChangeStandard Error 0.938
Healthy Controls Amisulpride Medication ScanMeasurement of Brain Activation (Measured in Percent Signal Change) During a Prediction Error Taste Reward Task Using Functional Magnetic Resonance Imaging (fMRI).Right Inferior Orbital Frontal Cortex Brain Activation0.396 Percent Signal ChangeStandard Error 0.803
Healthy Controls Amisulpride Medication ScanMeasurement of Brain Activation (Measured in Percent Signal Change) During a Prediction Error Taste Reward Task Using Functional Magnetic Resonance Imaging (fMRI).Right Ventral Insula Brain Activation0.883 Percent Signal ChangeStandard Error 0.716
Healthy Controls Amisulpride Medication ScanMeasurement of Brain Activation (Measured in Percent Signal Change) During a Prediction Error Taste Reward Task Using Functional Magnetic Resonance Imaging (fMRI).Left Ventral Striatum Brain Activation1.475 Percent Signal ChangeStandard Error 1.153
Healthy Controls Amisulpride Medication ScanMeasurement of Brain Activation (Measured in Percent Signal Change) During a Prediction Error Taste Reward Task Using Functional Magnetic Resonance Imaging (fMRI).Right Ventral Striatum Brain Activation1.728 Percent Signal ChangeStandard Error 1.02
Healthy Controls Amisulpride Medication ScanMeasurement of Brain Activation (Measured in Percent Signal Change) During a Prediction Error Taste Reward Task Using Functional Magnetic Resonance Imaging (fMRI).Left Inferior Orbital Frontal Cortex Brain Activation0.988 Percent Signal ChangeStandard Error 0.686
Anorexia Nervosa Amisulpride Medication ScanMeasurement of Brain Activation (Measured in Percent Signal Change) During a Prediction Error Taste Reward Task Using Functional Magnetic Resonance Imaging (fMRI).Left Ventral Insula Brain Activation-1.047 Percent Signal ChangeStandard Error 1.109
Anorexia Nervosa Amisulpride Medication ScanMeasurement of Brain Activation (Measured in Percent Signal Change) During a Prediction Error Taste Reward Task Using Functional Magnetic Resonance Imaging (fMRI).Right Ventral Insula Brain Activation-0.137 Percent Signal ChangeStandard Error 0.847
Anorexia Nervosa Amisulpride Medication ScanMeasurement of Brain Activation (Measured in Percent Signal Change) During a Prediction Error Taste Reward Task Using Functional Magnetic Resonance Imaging (fMRI).Left Ventral Striatum Brain Activation-0.599 Percent Signal ChangeStandard Error 1.365
Anorexia Nervosa Amisulpride Medication ScanMeasurement of Brain Activation (Measured in Percent Signal Change) During a Prediction Error Taste Reward Task Using Functional Magnetic Resonance Imaging (fMRI).Right Ventral Striatum Brain Activation-0.799 Percent Signal ChangeStandard Error 1.207
Anorexia Nervosa Amisulpride Medication ScanMeasurement of Brain Activation (Measured in Percent Signal Change) During a Prediction Error Taste Reward Task Using Functional Magnetic Resonance Imaging (fMRI).Left Inferior Orbital Frontal Cortex Brain Activation-1.222 Percent Signal ChangeStandard Error 0.811
Anorexia Nervosa Amisulpride Medication ScanMeasurement of Brain Activation (Measured in Percent Signal Change) During a Prediction Error Taste Reward Task Using Functional Magnetic Resonance Imaging (fMRI).Right Inferior Orbital Frontal Cortex Brain Activation-0.699 Percent Signal ChangeStandard Error 0.95
Healthy Controls Bromocriptine Medication ScanMeasurement of Brain Activation (Measured in Percent Signal Change) During a Prediction Error Taste Reward Task Using Functional Magnetic Resonance Imaging (fMRI).Right Ventral Insula Brain Activation4.117 Percent Signal ChangeStandard Error 0.987
Healthy Controls Bromocriptine Medication ScanMeasurement of Brain Activation (Measured in Percent Signal Change) During a Prediction Error Taste Reward Task Using Functional Magnetic Resonance Imaging (fMRI).Right Inferior Orbital Frontal Cortex Brain Activation5.512 Percent Signal ChangeStandard Error 1.244
Healthy Controls Bromocriptine Medication ScanMeasurement of Brain Activation (Measured in Percent Signal Change) During a Prediction Error Taste Reward Task Using Functional Magnetic Resonance Imaging (fMRI).Left Ventral Insula Brain Activation1.116 Percent Signal ChangeStandard Error 1.225
Healthy Controls Bromocriptine Medication ScanMeasurement of Brain Activation (Measured in Percent Signal Change) During a Prediction Error Taste Reward Task Using Functional Magnetic Resonance Imaging (fMRI).Left Inferior Orbital Frontal Cortex Brain Activation0.646 Percent Signal ChangeStandard Error 1.038
Healthy Controls Bromocriptine Medication ScanMeasurement of Brain Activation (Measured in Percent Signal Change) During a Prediction Error Taste Reward Task Using Functional Magnetic Resonance Imaging (fMRI).Right Ventral Striatum Brain Activation1.642 Percent Signal ChangeStandard Error 0.304
Healthy Controls Bromocriptine Medication ScanMeasurement of Brain Activation (Measured in Percent Signal Change) During a Prediction Error Taste Reward Task Using Functional Magnetic Resonance Imaging (fMRI).Left Ventral Striatum Brain Activation1.122 Percent Signal ChangeStandard Error 0.951
Anorexia Nervosa Bromocriptine Medication ScanMeasurement of Brain Activation (Measured in Percent Signal Change) During a Prediction Error Taste Reward Task Using Functional Magnetic Resonance Imaging (fMRI).Right Ventral Striatum Brain Activation1.732 Percent Signal ChangeStandard Error 0.359
Anorexia Nervosa Bromocriptine Medication ScanMeasurement of Brain Activation (Measured in Percent Signal Change) During a Prediction Error Taste Reward Task Using Functional Magnetic Resonance Imaging (fMRI).Right Ventral Insula Brain Activation2.650 Percent Signal ChangeStandard Error 1.167
Anorexia Nervosa Bromocriptine Medication ScanMeasurement of Brain Activation (Measured in Percent Signal Change) During a Prediction Error Taste Reward Task Using Functional Magnetic Resonance Imaging (fMRI).Left Inferior Orbital Frontal Cortex Brain Activation1.171 Percent Signal ChangeStandard Error 1.229
Anorexia Nervosa Bromocriptine Medication ScanMeasurement of Brain Activation (Measured in Percent Signal Change) During a Prediction Error Taste Reward Task Using Functional Magnetic Resonance Imaging (fMRI).Left Ventral Insula Brain Activation-0.148 Percent Signal ChangeStandard Error 1.45
Anorexia Nervosa Bromocriptine Medication ScanMeasurement of Brain Activation (Measured in Percent Signal Change) During a Prediction Error Taste Reward Task Using Functional Magnetic Resonance Imaging (fMRI).Right Inferior Orbital Frontal Cortex Brain Activation4.774 Percent Signal ChangeStandard Error 1.472
Anorexia Nervosa Bromocriptine Medication ScanMeasurement of Brain Activation (Measured in Percent Signal Change) During a Prediction Error Taste Reward Task Using Functional Magnetic Resonance Imaging (fMRI).Left Ventral Striatum Brain Activation1.328 Percent Signal ChangeStandard Error 1.126
Primary

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.

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

Population: 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

ArmMeasureGroupValue (MEAN)Dispersion
Healthy Controls Placebo ScanMeasurement of Brain Activation (Measured in Percent Signal Change) During Taste Stimulus Expectation Using Functional Magnetic Resonance Imaging (fMRI).Left Ventral Striatum Brain Activation1.558 Percent Signal ChangeStandard Error 0.347
Healthy Controls Placebo ScanMeasurement of Brain Activation (Measured in Percent Signal Change) During Taste Stimulus Expectation Using Functional Magnetic Resonance Imaging (fMRI).Right Ventral Insula Brain Activation3.884 Percent Signal ChangeStandard Error 0.526
Healthy Controls Placebo ScanMeasurement of Brain Activation (Measured in Percent Signal Change) During Taste Stimulus Expectation Using Functional Magnetic Resonance Imaging (fMRI).Left Ventral Insula Brain Activation4.799 Percent Signal ChangeStandard Error 0.681
Healthy Controls Placebo ScanMeasurement of Brain Activation (Measured in Percent Signal Change) During Taste Stimulus Expectation Using Functional Magnetic Resonance Imaging (fMRI).Right Inferior Orbital Frontal Cortex Brain Activation4.193 Percent Signal ChangeStandard Error 0.782
Healthy Controls Placebo ScanMeasurement of Brain Activation (Measured in Percent Signal Change) During Taste Stimulus Expectation Using Functional Magnetic Resonance Imaging (fMRI).Left Inferior Orbital Frontal Cortex Brain Activation3.649 Percent Signal ChangeStandard Error 0.48
Healthy Controls Placebo ScanMeasurement of Brain Activation (Measured in Percent Signal Change) During Taste Stimulus Expectation Using Functional Magnetic Resonance Imaging (fMRI).Right Ventral Striatum Brain Activation1.717 Percent Signal ChangeStandard Error 0.381
Anorexia Nervosa Placebo ScanMeasurement of Brain Activation (Measured in Percent Signal Change) During Taste Stimulus Expectation Using Functional Magnetic Resonance Imaging (fMRI).Left Ventral Striatum Brain Activation1.790 Percent Signal ChangeStandard Error 0.411
Anorexia Nervosa Placebo ScanMeasurement of Brain Activation (Measured in Percent Signal Change) During Taste Stimulus Expectation Using Functional Magnetic Resonance Imaging (fMRI).Left Ventral Insula Brain Activation3.282 Percent Signal ChangeStandard Error 0.806
Anorexia Nervosa Placebo ScanMeasurement of Brain Activation (Measured in Percent Signal Change) During Taste Stimulus Expectation Using Functional Magnetic Resonance Imaging (fMRI).Right Ventral Insula Brain Activation3.015 Percent Signal ChangeStandard Error 0.622
Anorexia Nervosa Placebo ScanMeasurement of Brain Activation (Measured in Percent Signal Change) During Taste Stimulus Expectation Using Functional Magnetic Resonance Imaging (fMRI).Right Ventral Striatum Brain Activation1.501 Percent Signal ChangeStandard Error 0.451
Anorexia Nervosa Placebo ScanMeasurement of Brain Activation (Measured in Percent Signal Change) During Taste Stimulus Expectation Using Functional Magnetic Resonance Imaging (fMRI).Left Inferior Orbital Frontal Cortex Brain Activation2.259 Percent Signal ChangeStandard Error 0.569
Anorexia Nervosa Placebo ScanMeasurement of Brain Activation (Measured in Percent Signal Change) During Taste Stimulus Expectation Using Functional Magnetic Resonance Imaging (fMRI).Right Inferior Orbital Frontal Cortex Brain Activation3.352 Percent Signal ChangeStandard Error 0.926
Healthy Controls Amisulpride Medication ScanMeasurement of Brain Activation (Measured in Percent Signal Change) During Taste Stimulus Expectation Using Functional Magnetic Resonance Imaging (fMRI).Right Inferior Orbital Frontal Cortex Brain Activation4.745 Percent Signal ChangeStandard Error 1.758
Healthy Controls Amisulpride Medication ScanMeasurement of Brain Activation (Measured in Percent Signal Change) During Taste Stimulus Expectation Using Functional Magnetic Resonance Imaging (fMRI).Left Inferior Orbital Frontal Cortex Brain Activation3.838 Percent Signal ChangeStandard Error 2.061
Healthy Controls Amisulpride Medication ScanMeasurement of Brain Activation (Measured in Percent Signal Change) During Taste Stimulus Expectation Using Functional Magnetic Resonance Imaging (fMRI).Right Ventral Insula Brain Activation4.436 Percent Signal ChangeStandard Error 2.406
Healthy Controls Amisulpride Medication ScanMeasurement of Brain Activation (Measured in Percent Signal Change) During Taste Stimulus Expectation Using Functional Magnetic Resonance Imaging (fMRI).Left Ventral Insula Brain Activation4.821 Percent Signal ChangeStandard Error 1.481
Healthy Controls Amisulpride Medication ScanMeasurement of Brain Activation (Measured in Percent Signal Change) During Taste Stimulus Expectation Using Functional Magnetic Resonance Imaging (fMRI).Left Ventral Striatum Brain Activation3.450 Percent Signal ChangeStandard Error 1.174
Healthy Controls Amisulpride Medication ScanMeasurement of Brain Activation (Measured in Percent Signal Change) During Taste Stimulus Expectation Using Functional Magnetic Resonance Imaging (fMRI).Right Ventral Striatum Brain Activation4.700 Percent Signal ChangeStandard Error 1.459
Anorexia Nervosa Amisulpride Medication ScanMeasurement of Brain Activation (Measured in Percent Signal Change) During Taste Stimulus Expectation Using Functional Magnetic Resonance Imaging (fMRI).Left Ventral Striatum Brain Activation2.860 Percent Signal ChangeStandard Error 1.39
Anorexia Nervosa Amisulpride Medication ScanMeasurement of Brain Activation (Measured in Percent Signal Change) During Taste Stimulus Expectation Using Functional Magnetic Resonance Imaging (fMRI).Right Ventral Insula Brain Activation5.866 Percent Signal ChangeStandard Error 2.847
Anorexia Nervosa Amisulpride Medication ScanMeasurement of Brain Activation (Measured in Percent Signal Change) During Taste Stimulus Expectation Using Functional Magnetic Resonance Imaging (fMRI).Right Inferior Orbital Frontal Cortex Brain Activation5.712 Percent Signal ChangeStandard Error 2.08
Anorexia Nervosa Amisulpride Medication ScanMeasurement of Brain Activation (Measured in Percent Signal Change) During Taste Stimulus Expectation Using Functional Magnetic Resonance Imaging (fMRI).Left Inferior Orbital Frontal Cortex Brain Activation6.392 Percent Signal ChangeStandard Error 2.439
Anorexia Nervosa Amisulpride Medication ScanMeasurement of Brain Activation (Measured in Percent Signal Change) During Taste Stimulus Expectation Using Functional Magnetic Resonance Imaging (fMRI).Left Ventral Insula Brain Activation5.569 Percent Signal ChangeStandard Error 1.752
Anorexia Nervosa Amisulpride Medication ScanMeasurement of Brain Activation (Measured in Percent Signal Change) During Taste Stimulus Expectation Using Functional Magnetic Resonance Imaging (fMRI).Right Ventral Striatum Brain Activation3.208 Percent Signal ChangeStandard Error 1.727
Healthy Controls Bromocriptine Medication ScanMeasurement of Brain Activation (Measured in Percent Signal Change) During Taste Stimulus Expectation Using Functional Magnetic Resonance Imaging (fMRI).Right Ventral Insula Brain Activation3.464 Percent Signal ChangeStandard Error 0.725
Healthy Controls Bromocriptine Medication ScanMeasurement of Brain Activation (Measured in Percent Signal Change) During Taste Stimulus Expectation Using Functional Magnetic Resonance Imaging (fMRI).Left Ventral Striatum Brain Activation1.206 Percent Signal ChangeStandard Error 0.39
Healthy Controls Bromocriptine Medication ScanMeasurement of Brain Activation (Measured in Percent Signal Change) During Taste Stimulus Expectation Using Functional Magnetic Resonance Imaging (fMRI).Left Ventral Insula Brain Activation5.265 Percent Signal ChangeStandard Error 0.803
Healthy Controls Bromocriptine Medication ScanMeasurement of Brain Activation (Measured in Percent Signal Change) During Taste Stimulus Expectation Using Functional Magnetic Resonance Imaging (fMRI).Right Ventral Striatum Brain Activation2.163 Percent Signal ChangeStandard Error 0.758
Healthy Controls Bromocriptine Medication ScanMeasurement of Brain Activation (Measured in Percent Signal Change) During Taste Stimulus Expectation Using Functional Magnetic Resonance Imaging (fMRI).Right Inferior Orbital Frontal Cortex Brain Activation5.362 Percent Signal ChangeStandard Error 1.13
Healthy Controls Bromocriptine Medication ScanMeasurement of Brain Activation (Measured in Percent Signal Change) During Taste Stimulus Expectation Using Functional Magnetic Resonance Imaging (fMRI).Left Inferior Orbital Frontal Cortex Brain Activation3.562 Percent Signal ChangeStandard Error 0.996
Anorexia Nervosa Bromocriptine Medication ScanMeasurement of Brain Activation (Measured in Percent Signal Change) During Taste Stimulus Expectation Using Functional Magnetic Resonance Imaging (fMRI).Left Inferior Orbital Frontal Cortex Brain Activation4.722 Percent Signal ChangeStandard Error 1.178
Anorexia Nervosa Bromocriptine Medication ScanMeasurement of Brain Activation (Measured in Percent Signal Change) During Taste Stimulus Expectation Using Functional Magnetic Resonance Imaging (fMRI).Right Inferior Orbital Frontal Cortex Brain Activation4.226 Percent Signal ChangeStandard Error 1.337
Anorexia Nervosa Bromocriptine Medication ScanMeasurement of Brain Activation (Measured in Percent Signal Change) During Taste Stimulus Expectation Using Functional Magnetic Resonance Imaging (fMRI).Right Ventral Striatum Brain Activation1.609 Percent Signal ChangeStandard Error 0.897
Anorexia Nervosa Bromocriptine Medication ScanMeasurement of Brain Activation (Measured in Percent Signal Change) During Taste Stimulus Expectation Using Functional Magnetic Resonance Imaging (fMRI).Left Ventral Striatum Brain Activation1.738 Percent Signal ChangeStandard Error 0.461
Anorexia Nervosa Bromocriptine Medication ScanMeasurement of Brain Activation (Measured in Percent Signal Change) During Taste Stimulus Expectation Using Functional Magnetic Resonance Imaging (fMRI).Left Ventral Insula Brain Activation4.691 Percent Signal ChangeStandard Error 0.95
Anorexia Nervosa Bromocriptine Medication ScanMeasurement of Brain Activation (Measured in Percent Signal Change) During Taste Stimulus Expectation Using Functional Magnetic Resonance Imaging (fMRI).Right Ventral Insula Brain Activation3.383 Percent Signal ChangeStandard Error 0.858

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026