- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03275545
Neural Correlates of Reward and Symptom Expression in Anorexia Nervosa
Study Overview
Detailed Description
Aim 1: To compare patterns of brain activity in reward circuits to typically rewarding cues and disorder-specific cues between weight-restored individuals with anorexia nervosa and non-eating disorder controls
Hypothesis 1a: Activity in reward circuitry will be elevated in response to typically rewarding cues in the non-eating disorder control group versus weight-restored anorexia nervosa group.
Hypothesis 1b: Activity in reward circuitry will be elevated in response to disorder-specific in the weight-restored anorexia nervosa group versus the non-eating disorder control group.
Aim 2: To specify the relationship between brain patterns related to reward and restrictive eating among weight-restored individuals with anorexia nervosa
Hypothesis 2a: Lower reward circuit activity in response to typically rewarding cues will predict lower test meal intake for weight-restored anorexia nervosa group versus the non-eating disorder control group.
Hypothesis 2b: Higher reward circuit activity in response to disorder-specific cues will predict lower test meal intake for the weight-restored anorexia nervosa group versus the non-eating disorder control group.
Aim 3: To identify the brain patterns in reward circuitry associated with the risk of relapse among weight-restored individuals with anorexia nervosa in the year following weight-restoration.
Hypothesis 3a: Lower reward circuit activity in response to typically rewarding cues will predict relapse in the weight-restored anorexia nervosa group.
Hypothesis 3b: Higher reward circuit activity in response to disorder-specific cues will predict relapse in the weight-restored anorexia nervosa group.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Minnesota
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Minneapolis, Minnesota, United States, 55414
- University of Minnesota
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age > 18 years old
- Current BMI > 18.5 kg/m2
- Ability to read and speak in English
- Right-handed
- Weight restored Anorexia Nervosa group: 1) DSM-5 diagnosis of AN in the past 6 months, with the exception of body image disturbance and intense fear of weight gain criteria; 2) BMI < 18.5 kg/m2 within past 6 months
Exclusion Criteria:
- Medical instability or current pregnancy
- Current substance use disorder, psychosis, or bipolar-I disorder
- Contraindication for fMRI
- History of neurological disorder/injury (e.g., stroke; head injury with > 10 minutes loss of consciousness)
- Food allergy that cannot be accommodated through substitutions to the laboratory test meal
- Lacking capacity to consent
- Non-eating disorder Control group: Current DSM-5 Axis-I diagnosis or current or past eating disorder diagnosis
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Anorexia Nervosa, Weight Restored
Individuals with a recent diagnosis of anorexia nervosa (within the past 6 months), who currently have their weight in a healthy range (BMI > or = 18.5 kg/m2)
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No intervention is being examined in this study
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Non-eating disorder Control
Individuals without a history of an eating disorder and no current DSM-5 psychiatric diagnoses.
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No intervention is being examined in this study
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Brain activation in reward circuits
Time Frame: Baseline
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Activation in regions of interest in reward brain circuitry (i.e., ventral tegmental area, nucleus accumbens) in response to typically-rewarding and disorder-specific tasks
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Baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Restrictive eating
Time Frame: Baseline
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Caloric consumption from a laboratory test meal
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Baseline
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Relapse
Time Frame: 12 months
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Relapse from anorexia nervosa, defined as: BMI < 18.5 kg/m2 and/or binge eating and/or purging > 1x/week for 3 consecutive months
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12 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ann Haynos, PhD, University of Minnesota
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PSYCH-2017-25878
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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