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MRI Study of Eating Behavior for Bulimia
N/A
Recruiting
Led By Laura A Berner, Ph.D.
Research Sponsored by Icahn School of Medicine at Mount Sinai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 6-month follow-up
Awards & highlights
No Placebo-Only Group
Summary
This trial wants to understand how bulimia nervosa affects people's decisions about control & eating, to develop better treatments.
Who is the study for?
This trial is for right-handed, English-speaking females aged 18-45 with a BMI between 18.5 and under 30 who meet the criteria for bulimia nervosa. It's not suitable for those medically unstable, on ongoing treatment, doing shift work, pregnant or lactating, allergic to meal ingredients used in the study, or unable to undergo an fMRI.
What is being tested?
The study examines how eating affects decision-making and self-control in women with bulimia nervosa by comparing their brain activity before and after eating using MRI scans while they are in fasting and fed states.
What are the potential side effects?
There may be minimal side effects related to fasting or consuming standardized meals. The MRI procedure might cause discomfort due to its enclosed nature but generally does not have significant side effects.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and 6-month follow-up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 6-month follow-up
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Frontostriatal Activation Associated with Prediction Errors on the Stop Signal Task
Frontostriatal Activation Encoding the Subjective Value of Cognitive Effort on the Cognitive-Effort Discounting Task
Secondary study objectives
Binge-eating Severity
Cognitive Effort Discounting Task Behavioral Performance
Compensatory Behavior Severity
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Participants with Bulimia NervosaExperimental Treatment3 Interventions
Participants are randomly assigned (in even numbers across the two groups) to scan order:
A. These participants are first scanned after 16 hours of fasting on one day, and are next scanned after a standardized meal on a second day.
B. These participants are first scanned after a standardized meal on one day, and are next scanned after 16 hours of fasting on a second day.
Group II: Participants without Bulimia NervosaActive Control3 Interventions
Participants are randomly assigned (in even numbers across the two groups) to scan order:
A. These participants are first scanned after 16 hours of fasting on one day, and are next scanned after a standardized meal on a second day.
B. These participants are first scanned after a standardized meal on one day, and are next scanned after 16 hours of fasting on a second day.
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Who is running the clinical trial?
Icahn School of Medicine at Mount SinaiLead Sponsor
904 Previous Clinical Trials
541,671 Total Patients Enrolled
3 Trials studying Bulimia Nervosa
156 Patients Enrolled for Bulimia Nervosa
National Institute of Mental Health (NIMH)NIH
2,918 Previous Clinical Trials
2,739,766 Total Patients Enrolled
27 Trials studying Bulimia Nervosa
41,272 Patients Enrolled for Bulimia Nervosa
Laura A Berner, Ph.D.Principal InvestigatorMount Sinai Icahn School of Medicine
1 Previous Clinical Trials
30 Total Patients Enrolled
1 Trials studying Bulimia Nervosa
30 Patients Enrolled for Bulimia Nervosa
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am female.I am between 18 and 45 years old.I have been diagnosed with bulimia nervosa according to DSM-5.
Research Study Groups:
This trial has the following groups:- Group 1: Participants with Bulimia Nervosa
- Group 2: Participants without Bulimia Nervosa
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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