- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00345943
An fMRI Study of Self-regulation in Adolescents With Bulimia Nervosa
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Patients with Bulimia Nervosa (BN) have difficulty regulating impulsive behaviors as suggested by their binge-eating and purging, as well as the high incidence of drug abuse and shoplifting in this population. Understanding dysfunction in the frontostriatal circuitry that mediates self-regulatory control processes will aid development of new therapeutics for the impulsivity associated with BN. We are conducting a longitudinal study to better understand the development and persistence of BN.
Participation in this study includes 4 sections: Neuropsychological Tests, Diagnostic interviews, Pregnancy Test, and MRI scan. All efforts are made to coordinate procedures into one day, and they require between 4 and 5 hours of the participant's time. The option of splitting participation into two study days is also offered for participants who find it more convenient. Participants are compensated with $100 in the form of a check, which is mailed to their home address. Participants will be invited back for follow-up visits.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10032
- New York State Psychiatric Institute at Columbia University Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Current or prior DSM IV diagnosis of Bulimia Nervosa or Sub-threshold Bulimia Nervosa (those who meet all DSM-IV criteria for BN, but engage in subjective binge-eating episodes and binge/purge at a frequency of at least once per week for 3 months, whereas meeting full DSM-IV criteria for BN requires binge eating and purging twice per week for 3 months)
- Major Depression
- For control adolescents, no current or past history of an eating disorder
Exclusion Criteria:
- Ferromagnetic implants (e.g., pacemaker)
- Metal braces or retainers
- IQ less than 80
- Any other current major Axis I disorder, other than major depressive disorder (MDD)
- History of concussion, seizure disorder, or other neurological illness
- Claustrophobia
- Pregnant
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Adolescents with Bulimia Nervosa or subclinical BN
Adolescents with Bulimia Nervosa or subclinical Bulimia Nervosa
|
Magnetic Resonance Imaging scans
Other Names:
Neuropsychological tests
Other Names:
|
|
Healthy control adolescents
|
Magnetic Resonance Imaging scans
Other Names:
Neuropsychological tests
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Magnetic Resonance Imaging Scans
Time Frame: Baseline
|
This study will use magnetic resonance imaging (MRI) to assess the structure (cortical thickness) of neural circuit regions involved in Bulimia Nervosa (BN).
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Conners Continuous Performance Test-II (CPT-II)
Time Frame: Baseline
|
The Conners Continuous Performance Test-II (CPT-II) is a standardized measure of attention and impulsivity. The following variables (T-scores) were used: Omissions: the number of times the participant failed to respond to a target. High T-score indicates a worse outcome. Commissions: the number of times the participant responded but no target was presented. High T-score indicates a worse outcome. Hit Reaction Time: time between the presentation of the stimulus and participant's response. A fast reaction time (low T-score) and high commission errors points to difficulties with impulsivity. A slow reaction time (high T-score) with high commission and omission errors, indicates inattention in general. Hit Reaction Time Standard Error: levels of inconsistency in response speed. High T-score indicates a worse outcome. Detectability: discrimination for target and nontarget. High T-score indicates a worse outcome. Population mean (standard deviation) = 50 (10) |
Baseline
|
|
Stroop Word-Color Interference
Time Frame: Baseline
|
The Stroop Word-Color Interference Test is a neuropsychological test assessing the ability to inhibit cognitive interference. The test contains three parts: word page (the names of colors printed in black ink), color page (rows of X's printed in colored ink) and word-color page (the words from the first page are printed in the colors from the second page; however, the word meanings and ink colors are mismatched).The subject's task is to look at each sheet and move down the columns, reading words or naming the ink colors as quickly as possible, within a given time limit (45 seconds). Three scores, as well as an interference score, are generated using the number of items completed on each page, with higher scores reflecting better performance and less interference on reading ability. Scores range 0-100. |
Baseline
|
|
Weather Prediction Task
Time Frame: Baseline
|
The Weather Prediction Task is a measure of probabilistic learning using experimental analysis of weather prediction.
In this task, participants try to predict either "rain" or "shine" based on the presentation of cards whose cue-outcome associations vary probabilistically.
Accuracy score (i.e. percentage of correct response) was used in our analyses.
A higher score indicates better outcome.
Values range 0-100%, with 50% being chance level.
|
Baseline
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Rachel Marsh, PhD, Columbia University
Publications and helpful links
General Publications
- Berner LA, Wang Z, Stefan M, Lee S, Huo Z, Cyr M, Marsh R. Subcortical Shape Abnormalities in Bulimia Nervosa. Biol Psychiatry Cogn Neurosci Neuroimaging. 2019 Dec;4(12):1070-1079. doi: 10.1016/j.bpsc.2018.12.011. Epub 2019 Jan 4.
- Cyr M, Wang Z, Tau GZ, Zhao G, Friedl E, Stefan M, Terranova K, Marsh R. Reward-Based Spatial Learning in Teens With Bulimia Nervosa. J Am Acad Child Adolesc Psychiatry. 2016 Nov;55(11):962-971.e3. doi: 10.1016/j.jaac.2016.07.778. Epub 2016 Sep 8.
- Marsh R, Maia TV, Peterson BS. Functional disturbances within frontostriatal circuits across multiple childhood psychopathologies. Am J Psychiatry. 2009 Jun;166(6):664-74. doi: 10.1176/appi.ajp.2009.08091354. Epub 2009 May 15.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- #5606R/6679R
- R01MH090062 (U.S. NIH Grant/Contract)
- DDTR M2-MBB
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Eating Disorders
-
Ibn Haldun UniversityCompletedDisordered Eating Behaviors | Eating Pathology | Eating Disorders SymptomsTurkey
-
Ibn Haldun UniversityActive, not recruitingDisordered Eating Behaviors | Eating Pathology | Eating Disorder SymptomsTurkey
-
University of PalermoUniversity of Padova; University of CatanzaroRecruitingEating Disorders | Eating Behavior | Eating Disorder SymptomItaly
-
Axsome Therapeutics, Inc.Enrolling by invitationBinge-Eating DisorderUnited States
-
BioprojetCompleted
-
Axsome Therapeutics, Inc.RecruitingBinge-Eating DisorderUnited States
-
Otsuka Pharmaceutical Development & Commercialization...CompletedBinge-Eating DisorderUnited States
-
Ali RezaiActive, not recruiting
-
Bezmialem Vakif UniversityMuğla Sıtkı Koçman University; The Scientific and Technological Research Council... and other collaboratorsActive, not recruitingEating Disorders | Eating Behavior | Orthodontic Appliance Complication | Eating HabitTurkey
-
University of North Carolina, Chapel HillThe Hilda & Preston Davis Foundation; Global Foundation for Eating DisordersCompletedEating Disorder | Binge-eating DisorderUnited States
Clinical Trials on MRI
-
Cambridge University Hospitals NHS Foundation TrustRecruitingBreast CancerUnited Kingdom
-
Seoul National University Bundang HospitalBayerCompletedTraumaKorea, Republic of
-
Vanderbilt-Ingram Cancer CenterNational Cancer Institute (NCI)TerminatedOsteosarcoma | Ewing Sarcoma | Paget's DiseaseUnited States
-
Assistance Publique Hopitaux De MarseilleActive, not recruitingMultiple SclerosisFrance
-
Abbott Medical DevicesCompletedAdverse Effect of MRI on an Implanted Pacemaker Lead | Adverse Effect of MRI on an Implanted PacemakerUnited States, Netherlands, Australia, Belgium, Finland
-
Centre Hospitalier Universitaire de Saint EtienneLohmann & RauscherRecruitingLow Back Pain | Healthy VolunteerFrance
-
Assistance Publique - Hôpitaux de ParisNot yet recruitingPatients with Atrial Fibrillation and Healthy Volunters
-
University of EdinburghCompleted
-
Assistance Publique - Hôpitaux de ParisUnknownBrain Injury, Coma | Cardiac Arrest (CA) | Traumatic Brain Injury (TBI) | Aneurysmal Subarachnoid Hemorrhages (aSAH)France
-
Sheba Medical CenterUnknown