An fMRI Study of Self-regulation in Adolescents With Bulimia Nervosa
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| First Received Date ICMJE | June 28, 2006 | ||||||||
| Last Updated Date | February 13, 2013 | ||||||||
| Start Date ICMJE | October 2004 | ||||||||
| Estimated Primary Completion Date | November 2014 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Functional magnetic resonance imaging scan [ Time Frame: Measured at a single visit ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Change History | Complete list of historical versions of study NCT00345943 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | An fMRI Study of Self-regulation in Adolescents With Bulimia Nervosa | ||||||||
| Official Title ICMJE | An fMRI Study of Self-regulation in Adolescents With Bulimia Nervosa | ||||||||
| Brief Summary | The aim of this project is to use both functional MRI (fMRI) and behavioral measures to investigate how disturbances in frontostriatal neural systems contribute to the impulsive and habitual binge-eating behaviors in patients with Bulimia Nervosa (BN). Findings from this study will have wide-ranging importance for our understanding of the development and treatment of BN. |
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| 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. Thus we aim to use fMRI and neuropsychological measures to investigate the functioning of frontostriatal systems and self-regulatory control processes in adolescents with 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. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Adolescents (ages 12-21 years) with bulimia nervosa and age, gender, and weight-matched controls |
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| Condition ICMJE | Eating Disorders | ||||||||
| Intervention ICMJE |
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| Study Group/Cohort (s) |
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| Publications * | Marsh R, Maia TV, Peterson BS. Functional disturbances within frontostriatal circuits across multiple childhood psychopathologies. Am J Psychiatry. 2009 Jun;166(6):664-74. Epub 2009 May 15. | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 80 | ||||||||
| Estimated Completion Date | November 2014 | ||||||||
| Estimated Primary Completion Date | November 2014 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||||||
| Ages | 12 Years to 21 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00345943 | ||||||||
| Other Study ID Numbers ICMJE | #5606R/6679R, K01MH077652, DDTR M2-MBB | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | New York State Psychiatric Institute | ||||||||
| Study Sponsor ICMJE | New York State Psychiatric Institute | ||||||||
| Collaborators ICMJE | National Institute of Mental Health (NIMH) | ||||||||
| Investigators ICMJE |
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| Information Provided By | New York State Psychiatric Institute | ||||||||
| Verification Date | February 2013 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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