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

December 1, 2021 updated by: Rachel Marsh, New York State Psychiatric Institute
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.

Study Overview

Status

Completed

Conditions

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

Observational

Enrollment (Actual)

71

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New York
      • New York, New York, United States, 10032
        • New York State Psychiatric Institute at Columbia University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 17 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

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

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:
  • GE 3T scanner
  • Anatomical Images, DTI, and MRS
Neuropsychological tests
Other Names:
  • Wechsler Abbreviated Scale of Intelligence (WASI)
  • Continuous Performance Task
  • Stroop Word-Color Interference
  • Weather Prediction Task
Healthy control adolescents
Magnetic Resonance Imaging scans
Other Names:
  • GE 3T scanner
  • Anatomical Images, DTI, and MRS
Neuropsychological tests
Other Names:
  • Wechsler Abbreviated Scale of Intelligence (WASI)
  • Continuous Performance Task
  • Stroop Word-Color Interference
  • Weather Prediction Task

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Rachel Marsh, PhD, Columbia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

August 1, 2021

Study Registration Dates

First Submitted

June 28, 2006

First Submitted That Met QC Criteria

June 28, 2006

First Posted (Estimate)

June 29, 2006

Study Record Updates

Last Update Posted (Actual)

December 2, 2021

Last Update Submitted That Met QC Criteria

December 1, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

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)?

YES

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.

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