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

Eating Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00345943
• Other study ID #: #5606R/6679R
• Secondary ID: R01MH090062DDTR
• Status: Completed
• Start date: October 2004
• Est. completion date: August 2021

Study information

• Verified date: December 2021
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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). Findings from this study will have wide-ranging importance for our understanding of the development and treatment of BN.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: August 2021
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 12 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Bulimia
• Bulimia Nervosa
• Eating Disorders
• Feeding and Eating Disorders

Intervention

Other:
• MRI
Magnetic Resonance Imaging scans

Behavioral:
• Neuropsychological Testing
Neuropsychological tests

Locations

Country	Name	City	State
United States	New York State Psychiatric Institute at Columbia University Medical Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York State Psychiatric Institute	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Baseline
Secondary	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)	Baseline
Secondary	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.	Baseline
Secondary	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.	Baseline