NCT03429114

Brief Summary

The study will examine the neural and behavioral correlates of emotion regulation in adolescents engaging in binge eating and/or purging and healthy adolescents. Furthermore, it will look at the influence of executive function on emotion regulation in this population. This study will allow us to gain further understanding of the neural basis of emotion regulation in this age group. Moreover, this study supports the need to develop new treatment approaches based on a better understanding of the brain processes associated with eating disorders.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
47

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2017

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

October 15, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 2, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 12, 2018

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

December 6, 2022

Status Verified

December 1, 2022

Enrollment Period

4.9 years

First QC Date

February 2, 2018

Last Update Submit

December 4, 2022

Conditions

Outcome Measures

Primary Outcomes (3)

  • Brain activity during emotion conflict

    Functional magnetic resonance imaging will be used to measure brain activity during a task where participants respond to images of faces with emotional expressions overlaid with an emotion word written in text. We will focus on brain response during this task when emotion face vs word are in conflict.

    Baseline

  • Brain activity during emotion regulation

    Functional magnetic resonance imaging will be used to measure brain activity during a task where participants attempt to regulate emotional responses.

    Baseline

  • Brain activity during cognitive control and emotion response

    Functional magnetic resonance imaging will be used to measure brain activity during a task where participants engage in cognitive control and respond to emotional stimuli.

    Baseline

Secondary Outcomes (3)

  • Behavioral performance on emotion conflict task

    Baseline

  • Behavioral performance on emotion regulation task

    Baseline

  • Behavioral performance on cognitive control and emotion regulation task

    Baseline

Study Arms (2)

Binge eating/purging

Adolescents engaging in recurrent binge eating and/or purging behavior.

Other: Magnetic resonance imaging

Healthy comparison

Adolescents who do not have a history of eating disorders

Other: Magnetic resonance imaging

Interventions

We will conduct MRI and fMRI brain scans to compare brain function between groups.

Binge eating/purgingHealthy comparison

Eligibility Criteria

Age14 Years - 18 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Female adolescents between ages 14-18.

You may qualify if:

  • Female
  • Ages 14-18
  • with or without current binge eating and/or purging behaviors

You may not qualify if:

  • We exclude patients of clinically significant low weight (\<85% ideal body weight using CDC norms for height, age, and gender) and those with contraindications for MRI (e.g., orthodontia, metallic implants). Participants also will be without evidence of current or past major neurological (e.g., seizures, psychosis, head trauma) or major sensory deficit.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University, Department of Psychiatry

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

BulimiaFeeding and Eating Disorders

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

HyperphagiaSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Design

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

Study Record Dates

First Submitted

February 2, 2018

First Posted

February 12, 2018

Study Start

October 15, 2017

Primary Completion

September 1, 2022

Study Completion

September 1, 2022

Last Updated

December 6, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations