Anxiety and Reward Interaction and Prediction of Outcomes in Anorexia Nervosa

NCT02948452 | Completed DMC

• 1 other identifier: 1R01MH105662-01A1
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to understand responsiveness to reward in adolescents with restricting-type anorexia nervosa compared with non-clinical controls, and how it is affected by potential-threat perception.

Conditions

Anorexia Nervosa, Restricting Type; Anxiety

Keywords

anorexia nervosa; anxiety; reward; recurrence; magnetic resonance imaging

Outcome Measures

Primary Outcomes (1)

• Blood oxygen level dependent (BOLD) percentage signal change as measured by fMRI in anxiety and reward brain regions of interest

  Mean BOLD percentage signal change between anxiety and control conditions will be compared across anorexia nervosa and comparison participants during the reward task

  within 3 weeks of discharge from an intensive treatment program

Secondary Outcomes (2)

• Body Mass Index (BMI) in kg/meter squared monthly for 6 months

  6 months

• Eating disorder symptoms

  beginning of study and at 6 months

Study Arms (2)

Anorexia

fMRI: reward task, anxiety provocation

Other: fMRI

Mild anxiety comparison group

fMRI: reward task, anxiety provocation

Other: fMRI

Interventions

fMRI OTHER

fMRI: reward task, anxiety provocation

Anorexia; Mild anxiety comparison group

Eligibility Criteria

• Age: 12 Years - 19 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Investigators will enroll 96 participants between the ages of 13 and 19 (48 with anorexia nervosa and 48 non-clinical controls matched by gender.

You may qualify if:

• Clinical diagnosis of Anorexia Nervosa, Restricting Type within the previous 6 months, (except for the amenorrhea criteria)
• completed treatment in an inpatient, residential, or partial hospitalization program (2-5 times/week) consisting of psychotherapy and dietary monitoring, within the previous 3 weeks
• May be unmedicated, or be taking a serotonin reuptake inhibitor medication at a stable dose for at least 8 weeks at the time of enrollment.

You may not qualify if:

• lifetime Axis I bipolar disorder, lifetime psychotic disorders, lifetime attention deficit hyperactivity disorder, or current post-traumatic stress disorder.
• current substance abuse or dependence, including nicotine
• pathological gambling, as assessed with the South Oaks Gambling Screen
• current neurological disorder
• pregnancy
• current major medical disorders that may affect cerebral metabolism such as diabetes or thyroid disorders
• current risk of suicide with a plan and intent
• a Children's Depression Rating Scale Revised (CDRS-R) score \>75 or major depressive disorder with psychotic features
• ferromagnetic metal implantations or devices (electronic implants or devices, infusion pumps, aneurysm clips, metal fragments or foreign bodies, metal prostheses, joints, rods or plates)
• adjusted BMI ≥ 25 (overweight)
• visual acuity worse than 20/35 for each eye as determined by Snellen close vision chart. Acuity may be met with corrective lenses.
• non-clinical females who score at least 1 standard deviation higher than population norms on the Depression Anxiety Stress Scale (DASS-21)
• any Axis I disorder
• any psychiatric medication.
• \- current substance abuse or dependence, including nicotine

Sponsors & Collaborators

• University of California, Los Angeles: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

UCLA

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Anorexia Nervosa; Anxiety Disorders; Recurrence

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jamie D Feusner, M.D.

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Jamie Feusner, M.D.

Study Record Dates

• First Submitted: October 3, 2016
• First Posted: October 28, 2016
• Study Start: November 1, 2015
• Primary Completion: April 30, 2021
• Study Completion: June 30, 2021
• Last Updated: May 31, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1)