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Incentive Processing and Learning in Anorexia Nervosa and Bulimia Nervosa

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ClinicalTrials.gov Identifier: NCT05056597
Recruitment Status : Not yet recruiting
First Posted : September 24, 2021
Last Update Posted : September 27, 2021
Sponsor:
Information provided by (Responsible Party):
Christina Wierenga, University of California, San Diego

Brief Summary:

The purpose of this study is to investigate areas of the brain responsible for 'liking', 'wanting', and learning in adults with eating disorders using brain imaging techniques, computer tasks, a test meal, and self-report questionnaires and interviews. The investigators will study changes in brain activity using a procedure called functional magnetic resonance imaging (fMRI). This study will include 252 women with an eating disorder (63 AN-restricting type (AN-R), 63 AN-binge eating/purging type (AN-BP), 63 bulimia nervosa (BN)) and 63 healthy controls (HC) aged 18-35.

Aim 1: To examine neural differences in 'liking' and 'wanting' in ED relative to HC.

Aim 2: To examine differences in instrumental learning for reward and punishment in ED relative to HC.

Aim 3: To examine how 'liking' and 'wanting' drive instrumental learning in ED and predict clinical symptoms at baseline and 1 year later.

Exploratory Aim: To explore the associations of dopamine function, as measured by neuromelanin MRI (NM-MRI), with ED diagnosis and brain response to 'liking', 'wanting', and learning.


Condition or disease
Anorexia Nervosa Bulimia Nervosa

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Study Type : Observational
Estimated Enrollment : 252 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Incentive Processing and Learning in Anorexia Nervosa and Bulimia Nervosa
Estimated Study Start Date : January 2022
Estimated Primary Completion Date : January 2027
Estimated Study Completion Date : January 2027

Group/Cohort
AN-R
Participants that meet Diagnostic And Statistical Manual Of Mental Disorders (DSM-V) criteria for Anorexia Nervosa restricting subtype.
AN-BP
Participants that meet DSM-V criteria for Anorexia Nervosa binging/purging subtype
BN
Participants that meet DSM-V criteria for Bulimia Nervosa.
Healthy Controls
Participants that do not meet DSM-V criteria for any disorder.



Primary Outcome Measures :
  1. BOLD response [ Time Frame: 1 Year ]
    Brain activity associated with 'liking', 'wanting', and learning

  2. Reward and Punishment Learning [ Time Frame: 1 Year ]
    Task reinforcement learning rate in reward and punishment trials

  3. Connectome-based predictive modeling (CPM) [ Time Frame: 1 Year ]
    Functional connectivity maps from task-based fMRI data and clinical data



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The study will recruit 189 adult women currently ill with ED including anorexia nervosa, restricting type (AN-R, n=63), AN binge eating/purging type (AN-BP, n=63), and bulimia nervosa (BN, n=63) and 63 healthy control (HC) women between the ages of 18 and 35.
Criteria

Inclusion Criteria:

Eating Disorder Group:

  • Between the ages of 18 and 35 years old
  • Meet DSM-V criteria for AN-R, AN-BP, or BN

Healthy Control Group:

  • Between the ages of 18 and 35 years old
  • Have maintained 85% to 120% ideal body weight since menarche

Exclusion Criteria:

All Groups:

  • Psychotic illness/other mental illness requiring hospitalization
  • Current dependence on drugs or alcohol defined by DSM IV criteria. Additionally, positive test results for drug use on the day of the scan, apart of marijuana, will result in cancelling or rescheduling the scan because acute use will impact MRI measures.
  • Physical conditions (e.g. diabetes mellitus, pregnancy) known to influence eating or weight
  • Neurological disorder, neurodevelopmental disorder, or history of head injury with >30 min loss of consciousness
  • Any contraindication to undergoing an MRI
  • Primary obsessive compulsive disorder or primary major depressive disorder

Additional Exclusion Criteria for ED Group:

-If taking other psychotropic medication, any change in dosage in the 2 weeks before scanning

Additional Exclusion Criteria for Healthy Control Group:

  • Meet criteria for the diagnosis of any psychiatric disorder currently
  • Any history of binge eating or purging behaviors, including self-induced vomiting, laxative or diuretic misuse
  • Use of any psychoactive or other medication known to affect mood or concentration in the last 3 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05056597


Contacts
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Contact: Christina Wierenga 858-534-8047 cwierenga@health.ucsd.edu

Locations
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United States, California
UCSD Eating Disorders Treatment and Research Program
La Jolla, California, United States, 92121
Contact: Megan Martinho    858-210-0318    mamartinho@health.ucsd.edu   
Principal Investigator: Christina Wierenga         
Sponsors and Collaborators
University of California, San Diego
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Responsible Party: Christina Wierenga, Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT05056597    
Other Study ID Numbers: 800775
First Posted: September 24, 2021    Key Record Dates
Last Update Posted: September 27, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anorexia
Bulimia
Anorexia Nervosa
Bulimia Nervosa
Signs and Symptoms, Digestive
Feeding and Eating Disorders
Mental Disorders
Hyperphagia