NCT03275545

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
79

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 5, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 7, 2017

Completed
6 months until next milestone

Study Start

First participant enrolled

February 28, 2018

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 12, 2022

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

September 21, 2022

Status Verified

September 1, 2022

Enrollment Period

4.4 years

First QC Date

September 5, 2017

Last Update Submit

September 18, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Restrictive eating

    Baseline

  • Relapse

    12 months

Study Arms (2)

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)

Other: No intervention

Non-eating disorder Control

Individuals without a history of an eating disorder and no current DSM-5 psychiatric diagnoses.

Other: No intervention

Interventions

No intervention is being examined in this study

Anorexia Nervosa, Weight RestoredNon-eating disorder Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Many participants will be community individuals self-referred to participate through a flyer or other study advertisement. Individuals who are patients at The Emily Program eating disorder treatment facility who are in the process of weight-restoration or who have recently been weight-restored from anorexia nervosa may also be presented with a flyer by clinical staff at the program through the process outlined above. Participants will also be recruited from logs of individuals who had previously participated in studies in our lab and stated that they would like to be contacted for future studies and our active recruitment log.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55414, United States

Location

MeSH Terms

Conditions

Anorexia Nervosa

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental Disorders

Study Officials

  • Ann Haynos, PhD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2017

First Posted

September 7, 2017

Study Start

February 28, 2018

Primary Completion

July 12, 2022

Study Completion

August 1, 2022

Last Updated

September 21, 2022

Record last verified: 2022-09

Locations