NCT02085057

Brief Summary

Individuals with anorexia nervosa (AN) have long been observed to demonstrate symptoms in common with obsessive-compulsive disorder (OCD), in particular, an obsessive fear of normal weight leading to dangerous food restriction, as well as many compulsive rituals about food. Both AN and OCD are seriously handicapping and often resistant to conventional therapies. Given that the two conditions often co-occur and are associated with still unknown genetic risk factors, the aim of this project is to identify their shared and distinct patterns of brain activity. The investigators propose to use functional magnetic resonance imaging to compare brain response among adolescents with AN, OCD, and age-matched healthy individuals. Specifically, this study will investigate function of distinct brain circuits related to core aspects of these related disorders. The investigators use three tasks related to set shifting, global vs. local processing, and reward. Based on evidence of deficits in cognitive flexibility and ability to change behavior, the investigators hypothesize that adolescents with AN and with OCD will show hypoactivity of frontostriatal circuitry during cognitive tasks, and adolescents with AN will show hyperactivity in limbic regions in a reward task. This study is the first to directly compare brain activation patterns using functional neuroimaging in AN and OCD. The goal is to determine how abnormal brain activity relates to symptom formation, what accounts for shared characteristics amongst these disorders, and whether deficits in specific circuitry underlie their unique defining features. The study of shared and unique elements of functional brain circuitry reflects a new, emerging approach to the classification of psychiatric illness, one based on identifying unique combinations of biological risk factors that link related conditions. This approach is widely believed to be a critical step forward in developing more brain-relevant targeted strategies for preventative interventions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2013

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

January 1, 2013

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 10, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 12, 2014

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

November 13, 2017

Status Verified

November 1, 2017

Enrollment Period

4.2 years

First QC Date

March 10, 2014

Last Update Submit

November 8, 2017

Conditions

Outcome Measures

Primary Outcomes (3)

  • Brain activity related to set shifting

    Baseline

  • Brain activity related to global vs. local processing

    Baseline

  • Brain activity related to reward

    Baseline

Study Arms (4)

anorexia nervosa

Diagnosis of anorexia nervosa

Procedure: Functional Magnetic Resonance Imaging

obsessive-compulsive disorder

Diagnosis of obsessive-compulsive disorder

Procedure: Functional Magnetic Resonance Imaging

healthy control

No psychiatric diagnoses

Procedure: Functional Magnetic Resonance Imaging

sisters

Sisters of those enrolled with a diagnosis of anorexia nervosa

Procedure: Functional Magnetic Resonance Imaging

Interventions

anorexia nervosahealthy controlobsessive-compulsive disordersisters

Eligibility Criteria

Age12 Years - 19 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Adolescent females ages 12-19 drawn from clinic and community populations. With diagnosis of anorexia nervosa or obsessive-compulsive disorder or no psychiatric diagnosis.

You may qualify if:

  • female
  • age 12-19
  • anorexia nervosa diagnosis OR obsessive-compulsive diagnosis OR no psychiatric disorder

You may not qualify if:

  • any contraindication for MRI (orthodontia, vascular stent, metallic ear tubes, metal implants, piercings, etc.)
  • neurological disorder, psychiatric disorder, or any major sensory deficit not associated with eating disorders or OCD (blindness, head trauma, bipolar disorder, seizure disorder, etc.)
  • pregnancy
  • below 85% of ideal body weight

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Anorexia NervosaObsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental DisordersAnxiety Disorders

Study Officials

  • Cara Bohon, PhD

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 10, 2014

First Posted

March 12, 2014

Study Start

January 1, 2013

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

November 13, 2017

Record last verified: 2017-11

Locations