An fMRI Study of Self-regulation in Adolescents With Bulimia Nervosa

NCT ID: NCT00345943

Last Updated: 2021-12-02

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

71 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-10-31

Study Completion Date

2021-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The aim of this project is to use both multimodal MRI and behavioral measures to investigate how changes in frontostriatal neural systems contribute to the development and persistence of Bulimia Nervosa (BN). Findings from this study will have wide-ranging importance for our understanding of the development and treatment of BN.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Eating Disorders

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Eating Disorders Bulimia Nervosa Bulimia fMRI Magnetic Resonance Imaging

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Adolescents with Bulimia Nervosa or subclinical BN

Adolescents with Bulimia Nervosa or subclinical Bulimia Nervosa

MRI

Intervention Type OTHER

Magnetic Resonance Imaging scans

Neuropsychological Testing

Intervention Type BEHAVIORAL

Neuropsychological tests

Healthy control adolescents

Healthy control adolescents

MRI

Intervention Type OTHER

Magnetic Resonance Imaging scans

Neuropsychological Testing

Intervention Type BEHAVIORAL

Neuropsychological tests

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

MRI

Magnetic Resonance Imaging scans

Intervention Type OTHER

Neuropsychological Testing

Neuropsychological tests

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

GE 3T scanner Anatomical Images, DTI, and MRS Wechsler Abbreviated Scale of Intelligence (WASI) Continuous Performance Task Stroop Word-Color Interference Weather Prediction Task

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

12 Years

Maximum Eligible Age

17 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

New York State Psychiatric Institute

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Rachel Marsh

Research Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Rachel Marsh, PhD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

New York State Psychiatric Institute at Columbia University Medical Center

New York, New York, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 30846367 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27806864 (View on PubMed)

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.

Reference Type DERIVED
PMID: 19448188 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R01MH090062

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DDTR M2-MBB

Identifier Type: -

Identifier Source: secondary_id

#5606R/6679R

Identifier Type: -

Identifier Source: org_study_id