NCT00345943

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2004

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

June 28, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 29, 2006

Completed
10.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
4.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
4 months until next milestone

Results Posted

Study results publicly available

December 2, 2021

Completed
Last Updated

December 2, 2021

Status Verified

December 1, 2021

Enrollment Period

11.9 years

First QC Date

June 28, 2006

Results QC Date

September 15, 2021

Last Update Submit

December 1, 2021

Conditions

Keywords

Eating DisordersBulimia NervosaBulimiafMRIMagnetic Resonance Imaging

Outcome Measures

Primary Outcomes (1)

  • Magnetic Resonance Imaging Scans

    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 Outcomes (3)

  • Conners Continuous Performance Test-II (CPT-II)

    Baseline

  • Stroop Word-Color Interference

    Baseline

  • Weather Prediction Task

    Baseline

Study Arms (2)

Adolescents with Bulimia Nervosa or subclinical BN

Adolescents with Bulimia Nervosa or subclinical Bulimia Nervosa

Other: MRIBehavioral: Neuropsychological Testing

Healthy control adolescents

Healthy control adolescents

Other: MRIBehavioral: Neuropsychological Testing

Interventions

MRIOTHER

Magnetic Resonance Imaging scans

Also known as: GE 3T scanner, Anatomical Images, DTI, and MRS
Adolescents with Bulimia Nervosa or subclinical BNHealthy control adolescents

Neuropsychological tests

Also known as: Wechsler Abbreviated Scale of Intelligence (WASI), Continuous Performance Task, Stroop Word-Color Interference, Weather Prediction Task
Adolescents with Bulimia Nervosa or subclinical BNHealthy control adolescents

Eligibility Criteria

Age12 Years - 17 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Adolescents (ages 12-17 years) with bulimia nervosa and age, gender, and weight-matched controls

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York State Psychiatric Institute at Columbia University Medical Center

New York, New York, 10032, United States

Location

Related Publications (3)

  • 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.

MeSH Terms

Conditions

Feeding and Eating DisordersBulimia NervosaBulimia

Interventions

Diffusion Tensor ImagingNeuropsychological Tests

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersHyperphagia

Intervention Hierarchy (Ancestors)

NeuroimagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisDiffusion Magnetic Resonance ImagingMagnetic Resonance ImagingTomographyDiagnostic Techniques, NeurologicalInvestigative TechniquesPsychological TestsBehavioral Disciplines and Activities

Results Point of Contact

Title
Dr. Rachel Marsh
Organization
New York State Psychiatric Institute

Study Officials

  • Rachel Marsh, PhD

    Columbia University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Scientist

Study Record Dates

First Submitted

June 28, 2006

First Posted

June 29, 2006

Study Start

October 1, 2004

Primary Completion

September 1, 2016

Study Completion

August 1, 2021

Last Updated

December 2, 2021

Results First Posted

December 2, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will share

Locations