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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03275545
Other study ID # PSYCH-2017-25878
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 28, 2018
Est. completion date August 1, 2022

Study information

Verified date September 2022
Source University of Minnesota
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The objective of this study is to identify the patterns of brain activity in reward circuitry that promote symptoms of anorexia nervosa. This project will compare weight-restored individuals with anorexia nervosa to a non-eating disorder control group on reward brain circuitry patterns in response to typically rewarding cues (i.e., entertaining videos) and disorder-specific restrictive eating cues (i.e., low-fat food choice) using fMRI. In addition, this study will examine which neurobiological reward responses among weight-restored individuals with anorexia nervosa predict objective restrictive eating (measured by laboratory meal intake) and longitudinal risk of relapse one year later.


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.


Recruitment information / eligibility

Status Completed
Enrollment 79
Est. completion date August 1, 2022
Est. primary completion date July 12, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
No intervention
No intervention is being examined in this study

Locations

Country Name City State
United States University of Minnesota Minneapolis Minnesota

Sponsors (1)

Lead Sponsor Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Brain activation in reward circuits 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 Baseline
Secondary Restrictive eating Caloric consumption from a laboratory test meal Baseline
Secondary Relapse Relapse from anorexia nervosa, defined as: BMI < 18.5 kg/m2 and/or binge eating and/or purging > 1x/week for 3 consecutive months 12 months
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