Bulimia NervosaSRBNNCT02997475
Neural Bases of Multiple Forms of Self-regulatory Control in Bulimia Nervosa
An observational study of Bulimia Nervosa, run by University of California, San Diego at 1 site in United States.
Trial summary
The purpose of this study is to investigate areas of the brain responsible for self-regulation in adult women who have never had an eating disorder with women who have bulimia nervosa. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bulimia Nervosa
- How many people
- 89 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to 31 Jul 2022
- 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 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women (ages 18-35 years) with bulimia nervosa, and age- and BMI-matched healthy controls.
General Inclusion Criteria:
- Female
- Right-handed
- Between the ages of 18 and 35 years *For Women with Bulimia Nervosa:
- Binge eating (i.e., eating a large amount of food while experiencing a sense of loss of control)
- Purging via self-induced vomiting (other methods may also be endorsed)
General Exclusion Criteria:
- Current significant medical illness or condition (e.g., diabetes, thyroid disease)
- Pregnancy, planned pregnancy, or lactation during the study period
- Non-removable metallic objects in the body
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSD Eating Disorders Center for Treatment and Research
San Diego, California, 92121
About this study
The purpose of this study is to investigate areas of the brain responsible for self-regulation in adult women who have never had an eating disorder with women who have bulimia nervosa. More specifically, investigators are interested in changes in brain activation (e.g., changes in blood flow and oxygen use) when inhibiting responses and regulating emotions. Data collection will rely on a technology called functional magnetic resonance imaging (fMRI).
- Conditions
- Bulimia Nervosa
- Keywords
- Bulimia Nervosa, Bulimia, fMRI, Emotion Regulation, Response Inhibition
- Medical subject headings
- Bulimia Nervosa, Bulimia, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Women with Bulimia Nervosa | Not described | |
| Women Healthy Controls | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-Regulatory Control
Functional Magnetic Resonance Imaging will be used to assess brain activation associated with motor inhibitory control and affect regulation in women with bulimia nervosa (BN)
Measured: Day 2 (fMRI Scan)
Secondary outcomes (2)
Goal-Directed Action Control
An computerized instrumental learning task will be used to assess performance of women with and without bulimia nervosa.
Measured: Day 1
Eating Disorder Relevance
The Eating Disorder Examination (EDE) will be conducted to assess relative associations of motor, affective, and goal-directed action control with bulimia nervosa severity.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2016 (estimated)
- Study startJun 2016
- Primary completion31 Jul 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bulimia NervosaStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe 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
- Prospective
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), The Hilda & Preston Davis Foundation
- Responsible party
- Principal investigator, Walter Kaye, University of California, San Diego
- Investigators
- Laura A. Berner, Ph.D., Study director, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02997475
- Sponsor's protocol ID
- 151514
- Other IDs
- F32MH108311
- Acronym
- SRBN
- Status last verified
- Jan 2023
- First submitted
- 25 Oct 2016
- Last updated
- 17 Jan 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Bases of Multiple Forms of Self-regulatory Control in Bulimia Nervosa
- ClinicalTrials.gov ID
- NCT02997475
- Acronym / sponsor ID
- SRBN / 151514
- Conditions
- Bulimia Nervosa
- Keywords
- Bulimia Nervosa, Bulimia, fMRI, Emotion Regulation, Response Inhibition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), The Hilda & Preston Davis Foundation
- Study start
- Jun 2016
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 20 Dec 2016 (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.
The purpose of this study is to investigate areas of the brain responsible for self-regulation in adult women who have never had an eating disorder with women who have bulimia nervosa. More specifically, investigators are interested in changes in brain activation (e.g., changes in blood flow and oxygen use) when inhibiting responses and regulating emotions. Data collection will rely on a technology called functional magnetic resonance imaging (fMRI).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Women with Bulimia Nervosa | – | – |
| Women Healthy Controls | – | – |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women (ages 18-35 years) with bulimia nervosa, and age- and BMI-matched healthy controls.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Self-Regulatory Control
Time frame: Day 2 (fMRI Scan)
Functional Magnetic Resonance Imaging will be used to assess brain activation associated with motor inhibitory control and affect regulation in women with bulimia nervosa (BN)
2 secondary outcomes
Goal-Directed Action Control
Time frame: Day 1
Eating Disorder Relevance
Time frame: Day 0
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 17 Jan 2023.
Related trials for Bulimia Nervosa
Not yet recruiting
Be Body Brave: Digital Written Exposure Therapy for Eating Disorders
Eating Disorders
Not yet recruiting
Effectiveness of a 10-week Multicomponent Intervention Combined With Parent Education on Binge Eating Behavior in Children and Adolescents
Binge Eating Disorder, Binge Eating
Recruiting
Understanding and Targeting Self-Regulatory Control in Bulimia Nervosa
Bulimia Nervosa, Feeding and Eating Disorders
Enrolling by invitation
Sleep and Activity For Eating Disorders
Eating Disorders, Anorexia Nervosa
Recruiting
Neurofeedback During Eating for Bulimia Nervosa
Bulimia Nervosa
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.
Laura A. Berner, Ph.D. study director
University of California, San Diego
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 Bulimia Nervosa, run by University of California, San Diego 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?
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 17 Jan 2023. 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?
Self-Regulatory Control (time frame: Day 2 (fMRI Scan)). 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 17 Jan 2023.