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An fMRI Study of Self-regulation in Adolescents With Bulimia Nervosa
This study is ongoing, but not recruiting participants.
Sponsor:
New York State Psychiatric Institute
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00345943
First received: June 28, 2006
Last updated: June 12, 2017
Last verified: June 2017
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Purpose
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.
| Condition | Intervention |
|---|---|
| Eating Disorders | Other: MRI Behavioral: Neuropsychological Testing |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Control Time Perspective: Prospective |
| Official Title: | An fMRI Study of Self-regulation in Adolescents With Bulimia Nervosa |
Further study details as provided by New York State Psychiatric Institute:
Primary Outcome Measures:
- Magnetic resonance imaging scans [ Time Frame: Measured at baseline and follow-up ]This study will use magnetic resonance imaging (MRI) to assess the structure, function, and connectivity of neural circuits involved in Bulimia Nervosa (BN).
Secondary Outcome Measures:
- Wechsler Abbreviated Scale of Intelligence (WASI) [ Time Frame: Measured at a single visit ]This estimates Full Scale IQ with excellent reliability and validity for ages 6-90.
- Continuous Performance Task [ Time Frame: Measured at baseline and follow-up ]The Continuous Performance Task (CPT) is a standardized measure of sustained attention and impulsivity.
- Stroop Word-Color Interference [ Time Frame: Measured at baseline and follow-up ]This is a classic task of cognitive interference that is comprised of 3 subtasks.
- Weather Prediction Task [ Time Frame: Measured at baseline and follow-up ]The Weather Prediction Task is a measure of probabilistic learning.
- Silverman [ Time Frame: Measured at baseline and follow-up ]This measure consists of one stimulus card and two response cards, each depicting a spatial array of common objects.
| Enrollment: | 71 |
| Study Start Date: | October 2004 |
| Estimated Study Completion Date: | September 2017 |
| Estimated Primary Completion Date: | September 2017 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Adolescents with Bulimia Nervosa or subclinical BN
Adolescents with Bulimia Nervosa or subclinical Bulimia Nervosa
|
Other: MRI
Magnetic Resonance Imaging scans
Other Names:
Behavioral: Neuropsychological Testing
Neuropsychological tests
Other Names:
|
|
Healthy control adolescents
Healthy control adolescents
|
Other: MRI
Magnetic Resonance Imaging scans
Other Names:
Behavioral: Neuropsychological Testing
Neuropsychological tests
Other Names:
|
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.
Eligibility| Ages Eligible for Study: | 12 Years to 17 Years (Child) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Study Population
Adolescents (ages 12-17 years) with bulimia nervosa and age, gender, and weight-matched controls
Criteria
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00345943
Please refer to this study by its ClinicalTrials.gov identifier: NCT00345943
Locations
| United States, New York | |
| New York State Psychiatric Institute at Columbia University Medical Center | |
| New York, New York, United States, 10032 | |
Sponsors and Collaborators
New York State Psychiatric Institute
National Institute of Mental Health (NIMH)
Investigators
| Principal Investigator: | Rachel Marsh, PhD | Columbia University |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | New York State Psychiatric Institute |
| ClinicalTrials.gov Identifier: | NCT00345943 History of Changes |
| Other Study ID Numbers: |
#5606R/6679R R01MH090062 ( US NIH Grant/Contract Award Number ) DDTR M2-MBB |
| Study First Received: | June 28, 2006 |
| Last Updated: | June 12, 2017 |
| Individual Participant Data | |
| Plan to Share IPD: | Yes |
Keywords provided by New York State Psychiatric Institute:
|
Eating Disorders Bulimia Nervosa Bulimia fMRI Magnetic Resonance Imaging |
Additional relevant MeSH terms:
|
Feeding and Eating Disorders Bulimia Bulimia Nervosa Mental Disorders |
Hyperphagia Signs and Symptoms, Digestive Signs and Symptoms |
ClinicalTrials.gov processed this record on June 28, 2017