Bulimia NervosaNCT01935401
Self-regulatory Control and Eating: A Neuroimaging Study of Bulimia Nervosa
An observational study of Bulimia Nervosa, run by Michael Lowe at 1 site in United States.
Trial summary
The purpose of this study will be to replicate previous findings of deficits in prefrontal activation during response inhibition tasks in bulimia nervosa and extend these findings by demonstrating similar deficiencies in activity during a functional behavioral task that requires the inhibition of eating. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bulimia Nervosa
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Sep 2014
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women (ages 18-45 years) with bulimia nervosa and age, BMI, and IQ-matched controls.
Who may be able to join
- Female
- Right-handed
- Age 18-45
- Between 85 and 120% of ideal body weight based on height
- Currently meeting proposed DSM-5 criteria for Bulimia Nervosa (at least one objective bulimic episode and compensatory purging episode per week for the past three months)
- Purging via self-induced vomiting
- Duration of illness of at least 6 months
Who cannot join
- Current significant medical illness
- Any disorder or condition resulting in difficulty swallowing (e.g., dysphagia)
- History of neurological disorders or diseases (e.g., stroke, seizures, heart disease, head trauma with loss of consciousness)
- Drug or alcohol abuse in the past 6 months or any history of alcohol or drug dependence
- Use of marijuana or any other illegal drug (e.g., cocaine, heroin, ecstasy) in the week before the study visit
- IQ less than 75
Show all 13Show fewer
- Pregnancy, lactation, or planning to become pregnant in the next year
- Allergy to sucrose, dairy, wheat, gluten, apples (i.e., any of the ingredients in the strawberry yogurt shake or in the standardized meal prior to study participation)
- Participants rating the strawberry yogurt shake as a 5 or lower on a 9-point category scale of liking will be excluded from further study
- Meeting the criteria for a diagnosis of Attention Deficit Hyperactivity Disorder
- Any other current major Axis I disorder, other than major depressive disorder (MDD) or generalized anxiety disorder (GAD)
- Inability to consent
- Prisoner
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study will be to replicate previous findings of deficits in prefrontal activation during response inhibition tasks in bulimia nervosa and extend these findings by demonstrating similar deficiencies in activity during a functional behavioral task that requires the inhibition of eating. Findings from this study will potentially help to elucidate the underlying neural mechanisms of bulimia nervosa, and thus inform treatment and prevention efforts.
Read the detailed description
Bulimia nervosa (BN), is a serious psychiatric disorder that has high rates of comorbidity and often results in role impairment for the suffer. Thus far, although psychosocial and behavioral risk factors and correlates of BN have been extensively researched, relatively few studies have focused on brain-based determinants of BN. Identification of neural mechanisms associated with self-regulatory control that may be integral in the development, maintenance, and prevention of this debilitating condition would better inform treatment development and eating disorder prevention efforts.
Participation in this study consists of a 3-3.5 hours study visit as well a a one year follow up visit. The first portion of initial study visit is part of the screening process, in which individuals will complete several questionnaires and be interviewed by the study researcher in order to confirm eligibility. If a participant is eligible after the screening portion, they move onto the rest of the initial visit. During the initial visit, participants will complete a button pressing go/no-go task as well as a sipping go/no-go task, all while wearing a functional near-infrared spectroscopy (fNIR) device.
At a one year follow up appointment, individuals will again complete a variety of self-report questionnaires and be interviewed by the study researcher, thus completing the same measures used as screening tools in the initial visit.
- Conditions
- Bulimia Nervosa
- Keywords
- Bulimia Nervosa, Bulimia, Response Inhibition, fNIR, Neuroimaging
- Medical subject headings
- Bulimia Nervosa, Bulimia
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 | fNIR - Functional near-infrared spectroscopy measured-brain activity | |
| Healthy Controls | fNIR - Functional near-infrared spectroscopy measured-brain activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional near-infrared spectroscopy
Measured: Day 1
Secondary outcomes (9)
Body mass index
Body mass index, calculated from height and weight measurements
Measured: Day 1 and 1 year
Eating disorder examination (EDE)
Used to assess eating disorder symptom frequency and severity, including binge eating episode frequency.
Measured: Day 1 and 1 Year
Wechsler Abbreviated Scale of Intelligence (WASI™)
Measured: Day 1
Mini-International Neuropsychiatric Interview (MINI)
Measured: Day 1
Button pressing go/no-go task
Measured: Day 1
Go/no-go sipping task
Measured: Day 1
Psychosocial self-report measures
Measures to be administered include: Power of Food Scale (PFS), Beck Anxiety Inventory (BAI), Center for Epidemiological Studies Depression Scale (CES-D), Barratt Impulsivity Scale, Version 11 (BIS), Eating Loss of Control Scale (ELOCS), Difficulties in Emotion Regulation Scale (DERS), and Behavioral Inhibition and Behavioral Activation (BIS/BAS) Scales
Measured: Day 1 and 1 Year
Positive and Negative Affect Schedule (PANAS)
This measure will assess mood ratings before the participant completes the standard go/no-go task and the sipping go/no-go task
Measured: Day 1
Generalized Labeled Magnitude Scale (gLMS)
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2013 (estimated)
- Study startJun 2011
- Primary completionSep 2014
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.
- 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
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michael Lowe
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Michael Lowe, Drexel University
- Investigators
- Michael R Lowe, Ph.D., Principal investigator, Drexel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01935401
- Sponsor's protocol ID
- 1F31MH097406
- Status last verified
- Oct 2014
- First submitted
- 5 Aug 2013
- Last updated
- 7 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-regulatory Control and Eating: A Neuroimaging Study of Bulimia Nervosa
- ClinicalTrials.gov ID
- NCT01935401
- Acronym / sponsor ID
- 1F31MH097406
- Conditions
- Bulimia Nervosa
- Keywords
- Bulimia Nervosa, Bulimia, Response Inhibition, fNIR, Neuroimaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Michael LoweUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Sep 2014 (actual)
- First posted
- 5 Sep 2013 (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 will be to replicate previous findings of deficits in prefrontal activation during response inhibition tasks in bulimia nervosa and extend these findings by demonstrating similar deficiencies in activity during a functional behavioral task that requires the inhibition of eating. Findings from this study will potentially help to elucidate the underlying neural mechanisms of bulimia nervosa, and thus inform treatment and prevention efforts.
Detailed description
Bulimia nervosa (BN), is a serious psychiatric disorder that has high rates of comorbidity and often results in role impairment for the suffer. Thus far, although psychosocial and behavioral risk factors and correlates of BN have been extensively researched, relatively few studies have focused on brain-based determinants of BN. Identification of neural mechanisms associated with self-regulatory control that may be integral in the development, maintenance, and prevention of this debilitating condition would better inform treatment development and eating disorder prevention efforts.
Participation in this study consists of a 3-3.5 hours study visit as well a a one year follow up visit. The first portion of initial study visit is part of the screening process, in which individuals will complete several questionnaires and be interviewed by the study researcher in order to confirm eligibility. If a participant is eligible after the screening portion, they move onto the rest of the initial visit. During the initial visit, participants will complete a button pressing go/no-go task as well as a sipping go/no-go task, all while wearing a functional near-infrared spectroscopy (fNIR) device.
At a one year follow up appointment, individuals will again complete a variety of self-report questionnaires and be interviewed by the study researcher, thus completing the same measures used as screening tools in the initial visit.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Women with Bulimia Nervosa | – | –fNIR - Functional near-infrared spectroscopy measured-brain activity |
| Healthy Controls | – | –fNIR - Functional near-infrared spectroscopy measured-brain activity |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women (ages 18-45 years) with bulimia nervosa and age, BMI, and IQ-matched controls.
Key inclusion criteria (7 listed)
- Female
- Right-handed
- Age 18-45
- Between 85 and 120% of ideal body weight based on height
- Currently meeting proposed DSM-5 criteria for Bulimia Nervosa (at least one objective bulimic episode and compensatory purging episode per week for the past three months)
Key exclusion criteria (13 listed)
- Current significant medical illness
- Any disorder or condition resulting in difficulty swallowing (e.g., dysphagia)
- History of neurological disorders or diseases (e.g., stroke, seizures, heart disease, head trauma with loss of consciousness)
- Drug or alcohol abuse in the past 6 months or any history of alcohol or drug dependence
- Use of marijuana or any other illegal drug (e.g., cocaine, heroin, ecstasy) in the week before the study visit
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
Functional near-infrared spectroscopy
Time frame: Day 1
9 secondary outcomes
Body mass index
Time frame: Day 1 and 1 year
Eating disorder examination (EDE)
Time frame: Day 1 and 1 Year
Wechsler Abbreviated Scale of Intelligence (WASI™)
Time frame: Day 1
Mini-International Neuropsychiatric Interview (MINI)
Time frame: Day 1
Button pressing go/no-go task
Time frame: Day 1
Go/no-go sipping task
Time frame: Day 1
Psychosocial self-report measures
Time frame: Day 1 and 1 Year
Positive and Negative Affect Schedule (PANAS)
Time frame: Day 1
Generalized Labeled Magnitude Scale (gLMS)
Time frame: Day 1
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 7 Oct 2014.
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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.
Michael R Lowe, Ph.D. principal investigator
Drexel 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 Bulimia Nervosa, run by Michael Lowe 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 7 inclusion and 13 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 7 Oct 2014. 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?
Functional near-infrared spectroscopy (time frame: Day 1). 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 7 Oct 2014.