NCT04051879

Brief Summary

The proposed study of adolescents with anorexia nervosa (AN) will examine the association of behavioral differences in constructs of decision making, brain structure and connectivity, and eating disorder (ED) symptoms. This study tests the novel hypothesis that goal-directed and habit learning for reward and punishment is altered in AN and is uniquely associated with divergent symptoms and differences in corticostriatal connectivity and microstructural integrity. We will recruit 78 females currently ill with AN and 26 controls ages 13-17 to investigate how goal-directed and habit learning for reward and punishment correspond to 1) clinical symptoms collected via interviews, self-report assessments, and ecological momentary assessment (EMA), and 2) brain structure and connectivity in the resting state. Data collection will rely on a technology called functional magnetic resonance imaging (fMRI).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
78

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2019

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

Study Start

First participant enrolled

April 1, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 2, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 9, 2019

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 24, 2025

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 8, 2026

Completed
Last Updated

May 11, 2026

Status Verified

May 1, 2026

Enrollment Period

6 years

First QC Date

August 2, 2019

Last Update Submit

May 8, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Learning Task

    A learning computer task will be used to dissociate model-based and model-free learning.

    Computer Task (Baseline)

  • Brain Function

    Functional Magnetic Resonance Imaging will be used to correlate brain function with a weighting factor (ω), representing the relative balance between learning biases.

    fMRI Scan (Baseline)

Study Arms (3)

AN-R

Participants that meet Diagnostic And Statistical Manual Of Mental Disorders (DSM-V) criteria for Anorexia Nervosa restricting subtype.

AN-BP

Participants that meet DSM-V criteria for Anorexia Nervosa binging/purging subtype.

Healthy Controls

Participants that do not meet DSM-V criteria for any disorder.

Eligibility Criteria

Age13 Years - 17 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

We will recruit from a clinical sample for the AN groups. We will recruit from a community sample for the healthy control group.

You may qualify if:

  • AN Group:
  • Between the ages of 13 and 17 years old
  • Meet DSM-V criteria for AN-R or AN-BP
  • Medically stable per American Academy of Pediatrics and the Society of Adolescent Medicine requirements, at least 75% adjusted ideal body weight, but still symptomatic as assessed by the Eating Disorders Examination and clinical report
  • Be at least 75% of adjusted ideal body weight
  • Healthy Control Group:
  • Between the ages of 13 and 17 years old

You may not qualify if:

  • All Groups:
  • Psychotic illness/other mental illness requiring hospitalization
  • Current dependence on drugs or alcohol defined by DSM IV criteria. Additionally, positive test results for drug use on the day of the scan, apart of marijuana, will result in cancelling or rescheduling the scan because acute use will impact MRI measures.
  • Physical conditions (e.g. diabetes mellitus, pregnancy) known to influence eating or weight
  • Neurological disorder, neurodevelopmental disorder, or history of head injury with \>30 min loss of consciousness
  • Any contraindication to undergoing an MRI
  • Primary obsessive compulsive disorder or primary major depressive disorder
  • If taking other psychotropic medication, any change in dosage in the 2 weeks before scanning
  • Meet or met criteria for the diagnosis of any psychiatric disorder in their lifetime
  • Any history of binge eating or purging behaviors, including self-induced vomiting, laxative or diuretic misuse
  • Use of any psychoactive or other medication known to affect mood or concentration in the last 3 months
  • Have maintained 90% to 120% ideal body weight since menarche

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Diego

San Diego, California, 92121, United States

Location

MeSH Terms

Conditions

Anorexia Nervosa

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental Disorders

Study Officials

  • Christina Wierenga, PhD

    University of California, San Diego

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 2, 2019

First Posted

August 9, 2019

Study Start

April 1, 2019

Primary Completion

March 24, 2025

Study Completion

May 8, 2026

Last Updated

May 11, 2026

Record last verified: 2026-05

Locations