Overview

This trial is active, not recruiting.

Condition eating disorders
Treatments mri, neuropsychological testing
Sponsor New York State Psychiatric Institute
Collaborator National Institute of Mental Health (NIMH)
Start date October 2004
End date November 2016
Trial size 80 participants
Trial identifier NCT00345943, #5606R/6679R, DDTR M2-MBB, R01MH090062

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Arm
Adolescents with Bulimia Nervosa or subclinical Bulimia Nervosa
mri GE 3T scanner
Magnetic Resonance Imaging scans
neuropsychological testing Wechsler Abbreviated Scale of Intelligence (WASI)
Neuropsychological tests
Healthy control adolescents
mri GE 3T scanner
Magnetic Resonance Imaging scans
neuropsychological testing Wechsler Abbreviated Scale of Intelligence (WASI)
Neuropsychological tests

Primary Outcomes

Measure
Magnetic resonance imaging scans
time frame: Measured at baseline and follow-up

Secondary Outcomes

Measure
Wechsler Abbreviated Scale of Intelligence (WASI)
time frame: Measured at a single visit
Continuous Performance Task
time frame: Measured at baseline and follow-up
Stroop Word-Color Interference
time frame: Measured at baseline and follow-up
Weather Prediction Task
time frame: Measured at baseline and follow-up
Silverman
time frame: Measured at baseline and follow-up

Eligibility Criteria

Female participants from 12 years up to 17 years old.

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

Additional Information

Official title An fMRI Study of Self-regulation in Adolescents With Bulimia Nervosa
Principal investigator Rachel Marsh, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by New York State Psychiatric Institute.