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Eating DisordersNCT00345943

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

An observational study of Eating Disorders, run by New York State Psychiatric Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 12 to 17 years, women onlyHealthy volunteers can take part
Conditions the study is for
Eating Disorders
What is being tested?
MRI and Neuropsychological Testing
How many people
71 participants
Where
1 siteUnited States
Study dates
Oct 2004to Aug 2021
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 17 years
  • Women only
  • Healthy volunteers accepted
  • Child

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

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • New York State Psychiatric Institute at Columbia University Medical Center

    New York, New York, 10032

Other trials in United States

About this study

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.

Read the 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.

Being tested
MRI, Neuropsychological Testing
Keywords
Eating Disorders, Bulimia Nervosa, Bulimia, fMRI, Magnetic Resonance Imaging
Medical subject headings
Feeding and Eating Disorders, Bulimia Nervosa, Bulimia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MRIOther

    Also called GE 3T scanner, Anatomical Images, DTI, and MRS

    Magnetic Resonance Imaging scans

  • Neuropsychological TestingBehavioural

    Also called Wechsler Abbreviated Scale of Intelligence (WASI), Continuous Performance Task, Stroop Word-Color Interference, Weather Prediction Task

    Neuropsychological tests

Study groups in NCT00345943
Study groupRoleWhat they receive
Adolescents with Bulimia Nervosa or subclinical BNAdolescents with Bulimia Nervosa or subclinical Bulimia Nervosa
Receives: Other: MRI; Behavioral: Neuropsychological Testing
Healthy control adolescentsHealthy control adolescents
Receives: Other: MRI; Behavioral: Neuropsychological Testing

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: Baseline

Secondary outcomes (3)

  1. Conners Continuous Performance Test-II (CPT-II)

    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)

    Measured: Baseline

  2. Stroop Word-Color Interference

    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.

    Measured: Baseline

  3. Weather Prediction Task

    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.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jun 2006 (estimated)
  2. Study startOct 2004
  3. Primary completionSep 2016
  4. Study completionAug 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
71 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00345943
Sponsor's protocol ID
#5606R/6679R
Other IDs
R01MH090062, DDTR M2-MBB
Status last verified
Dec 2021
First submitted
28 Jun 2006
Last updated
2 Dec 2021
Data monitoring committee
Yes
Individual data sharing
Yes

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.

    PubMed 30846367

  • 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.

    PubMed 27806864

  • 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.

    PubMed 19448188

Questions about this trial

What is this clinical trial studying?

An observational study of Eating Disorders, run by New York State Psychiatric Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Magnetic Resonance Imaging Scans (time frame: Baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00345943, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2021.

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