Anorexia NervosaNCT02085057
Neural Links Between OCD and Anorexia
An observational study of Anorexia Nervosa and Obsessive-compulsive Disorder, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 19 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anorexia Nervosa, Obsessive-compulsive Disorder
- What is being tested?
- Functional Magnetic Resonance Imaging
- Type of treatment
- Surgery or procedure
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to 1 Apr 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 19 years
- Women only
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- female
- age 12-19
- anorexia nervosa diagnosis OR obsessive-compulsive diagnosis OR no psychiatric disorder
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: Shared and Unique Neural Links Between OCD and Anorexia: Investigating Biological Mechanisms of Phenotypic Expression
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.
- Conditions
- Anorexia Nervosa, Obsessive-compulsive Disorder
- Being tested
- Functional Magnetic Resonance Imaging
- Medical subject headings
- Anorexia Nervosa, Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional Magnetic Resonance ImagingProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| anorexia nervosa | Diagnosis of anorexia nervosa Receives: Procedure: Functional Magnetic Resonance Imaging | |
| obsessive-compulsive disorder | Diagnosis of obsessive-compulsive disorder Receives: Procedure: Functional Magnetic Resonance Imaging | |
| healthy control | No psychiatric diagnoses Receives: Procedure: Functional Magnetic Resonance Imaging | |
| sisters | Sisters of those enrolled with a diagnosis of anorexia nervosa Receives: Procedure: Functional Magnetic Resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain activity related to set shifting
Measured: Baseline
Brain activity related to global vs. local processing
Measured: Baseline
Brain activity related to reward
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2014 (estimated)
- Study startJan 2013
- Primary completion1 Apr 2017
- Study completion1 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cara Bohon, PhD, Stanford University
- Investigators
- Cara Bohon, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02085057
- Sponsor's protocol ID
- 18888
- Status last verified
- Nov 2017
- First submitted
- 10 Mar 2014
- Last updated
- 13 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shared and Unique Neural Links Between OCD and Anorexia: Investigating Biological Mechanisms of Phenotypic Expression
- ClinicalTrials.gov ID
- NCT02085057
- Acronym / sponsor ID
- 18888
- Conditions
- Anorexia Nervosa, Obsessive-compulsive Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- 1 Apr 2017 (actual)
- Study completion
- 1 Apr 2017 (actual)
- First posted
- 12 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| anorexia nervosa | – | Procedure: Functional Magnetic Resonance ImagingDiagnosis of anorexia nervosa |
| obsessive-compulsive disorder | – | Procedure: Functional Magnetic Resonance ImagingDiagnosis of obsessive-compulsive disorder |
| healthy control | – | Procedure: Functional Magnetic Resonance ImagingNo psychiatric diagnoses |
| sisters | – | Procedure: Functional Magnetic Resonance ImagingSisters of those enrolled with a diagnosis of anorexia nervosa |
Who may qualify
- Ages
- 12 to 19 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (3 listed)
- female
- age 12-19
- anorexia nervosa diagnosis OR obsessive-compulsive diagnosis OR no psychiatric disorder
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional Magnetic Resonance Imaging | Procedure or surgery | anorexia nervosa, healthy control, obsessive-compulsive disorder, sisters |
Primary outcome
Brain activity related to set shifting
Time frame: Baseline
Brain activity related to global vs. local processing
Time frame: Baseline
Brain activity related to reward
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cara Bohon, PhD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anorexia Nervosa and Obsessive-compulsive Disorder, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain activity related to set shifting (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2017; AzTrials last refreshed its copy on 29 Oct 2026.