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Anxiety and Reward Interaction and Prediction of Outcomes in Anorexia Nervosa

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ClinicalTrials.gov Identifier: NCT02948452
Recruitment Status : Recruiting
First Posted : October 28, 2016
Last Update Posted : February 20, 2018
Sponsor:
Information provided by (Responsible Party):
Jamie Feusner, University of California, Los Angeles

Brief Summary:
This study is designed to understand responsiveness to reward in adolescents with restricting-type anorexia nervosa compared with non-clinical controls, and how it is affected by potential-threat perception.

Condition or disease Intervention/treatment
Anorexia Nervosa, Restricting Type Anxiety Other: fMRI

Detailed Description:
The objective of this study is to understand the effects of anxiety on reward responsiveness in adolescents with anorexia nervosa (AN), and how this interaction predicts behavioral outcome subsequent to intensive treatment. Investigators plan to test, for the first time, how acute activation of threat related emotional circuitry reciprocally alters reward circuit activity, and to what degree this modulation predicts post treatment relapse. The severity of AN, its resistance to intervention, potential for quick return of illness, risk for long-term chronicity, and premature death, are well appreciated. Various forms of intensive treatment may succeed in at least partial weight restoration, yet early relapse is unusually high. The appearance early in life of prodromal anxiety phenotypes in individuals who subsequently develop AN is well documented and nearly universal. Anxiety proneness in concert with rigid self-discipline may therefore be predisposing substrates for sudden morbid apprehension about weight gain, and may contribute to subsequent behaviors including vigilant scrutiny of body size and shape and inflexible cognitive patterns regarding food and eating. In parallel, persons with restricting-type AN typically exhibit unease and reticence when exposed to novel, high reward environments. Most studies have found low fun-seeking, low novelty seeking, and reduced reward responsiveness in those with AN. In line with these observations, functional magnetic resonance imaging (fMRI) studies demonstrate aberrant reward sensitivity and reward circuit activation. However the interaction of anxiety and reward circuits has never been interrogated. There is substantial evidence of distinct yet overlapping neural systems mediating approach/reward and avoidance/anxiety, which are integrated in balancing and switching between behaviors related to the predominant valence state. Thus investigators posit that high degrees of reactivity of cortico-limbic circuits underlying anxiety may contribute mechanistically and functionally to diminished initial responsiveness to reward stimuli. This may translate clinically to lower motivation to engage in outpatient treatment - in effect, a lower drive to change behaviors and thought patterns necessary for maintaining gains or improving, based on expectancy of benefits of future outcome. The dynamic interaction between reward and anxiety systems in AN, and how dysregulation of connectivity within and between these systems mediates behavioral outcomes, has not previously been tested. Investigators will investigate this interaction using sequential fMRI paradigms and novel integrated functional-by-structural connectivity in individuals who have completed standard treatment on an eating disorder unit. Investigators will then investigate how this neural circuitry may predict degree of relapse during the subsequent 6 months.

Study Type : Observational
Estimated Enrollment : 96 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Anxiety and Reward Interaction and Prediction of Outcomes in Anorexia Nervosa
Study Start Date : November 2015
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Group/Cohort Intervention/treatment
Anorexia
fMRI: reward task, anxiety provocation
Other: fMRI
fMRI: reward task, anxiety provocation

Mild anxiety comparison group
fMRI: reward task, anxiety provocation
Other: fMRI
fMRI: reward task, anxiety provocation




Primary Outcome Measures :
  1. Blood oxygen level dependent (BOLD) percentage signal change as measured by fMRI in anxiety and reward brain regions of interest [ Time Frame: within 3 weeks of discharge from an intensive treatment program ]
    Mean BOLD percentage signal change between anxiety and control conditions will be compared across anorexia nervosa and comparison participants during the reward task


Secondary Outcome Measures :
  1. Body Mass Index (BMI) in kg/meter squared monthly for 6 months [ Time Frame: 6 months ]
    Trajectory of BMI over 6 months after intensive treatment will be analyzed

  2. Eating disorder symptoms [ Time Frame: beginning of study and at 6 months ]
    Eating Disorder Examination (EDE)



Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Investigators will enroll 96 participants between the ages of 13 and 19 (48 with anorexia nervosa and 48 non-clinical controls matched by gender.
Criteria

Inclusion criteria for AN participants:

  • Clinical diagnosis of Anorexia Nervosa, Restricting Type within the previous 6 months, (except for the amenorrhea criteria)
  • completed treatment in an inpatient, residential, or partial hospitalization program (2-5 times/week) consisting of psychotherapy and dietary monitoring, within the previous 3 weeks
  • May be unmedicated, or be taking a serotonin reuptake inhibitor medication at a stable dose for at least 8 weeks at the time of enrollment.

Exclusion criteria for AN participants:

  • lifetime Axis I bipolar disorder, lifetime psychotic disorders, lifetime attention deficit hyperactivity disorder, or current post-traumatic stress disorder.
  • current substance abuse or dependence, including nicotine
  • pathological gambling, as assessed with the South Oaks Gambling Screen
  • current neurological disorder
  • pregnancy
  • current major medical disorders that may affect cerebral metabolism such as diabetes or thyroid disorders
  • current risk of suicide with a plan and intent
  • a Children's Depression Rating Scale Revised (CDRS-R) score >75 or major depressive disorder with psychotic features
  • ferromagnetic metal implantations or devices (electronic implants or devices, infusion pumps, aneurysm clips, metal fragments or foreign bodies, metal prostheses, joints, rods or plates)
  • adjusted BMI ≥ 25 (overweight)
  • visual acuity worse than 20/35 for each eye as determined by Snellen close vision chart. Acuity may be met with corrective lenses.

Inclusion criteria for controls:

  • non-clinical females who score at least 1 standard deviation higher than population norms on the Depression Anxiety Stress Scale (DASS-21)

Exclusion criteria for controls:

  • any Axis I disorder
  • any psychiatric medication.
  • - current substance abuse or dependence, including nicotine
  • pathological gambling, as assessed with the South Oaks Gambling Screen
  • current neurological disorder
  • pregnancy
  • current major medical disorders that may affect cerebral metabolism such as diabetes or thyroid disorders
  • current risk of suicide with a plan and intent
  • a Children's Depression Rating Scale Revised (CDRS-R) score >75 or major depressive disorder with psychotic features
  • ferromagnetic metal implantations or devices (electronic implants or devices, infusion pumps, aneurysm clips, metal fragments or foreign bodies, metal prostheses, joints, rods or plates)
  • adjusted BMI ≥ 25 (overweight)
  • visual acuity worse than 20/35 for each eye as determined by Snellen close vision chart. Acuity may be met with corrective lenses.

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): NCT02948452


Contacts
Contact: Courtney Sheen, M.A. 310 206-0468 csheen@mednet.ucla.edu

Locations
United States, California
UCLA Recruiting
Los Angeles, California, United States, 90095
Contact: Jamie D Feusner, M.D.    310-206-4951    jfeusner@mednet.ucla.edu   
Contact: Courtney L Sheen, M.A.    310 206-0468    csheen@mednet.ucla.edu   
Principal Investigator: Jamie D Feusner, M.D.         
Sponsors and Collaborators
University of California, Los Angeles
Investigators
Principal Investigator: Jamie D Feusner, M.D. University of California, Los Angeles

Responsible Party: Jamie Feusner, Jamie Feusner, M.D., University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT02948452     History of Changes
Other Study ID Numbers: 1R01MH105662-01A1 ( U.S. NIH Grant/Contract )
First Posted: October 28, 2016    Key Record Dates
Last Update Posted: February 20, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Investigators will share deidentified subject-level data loaded to the new database for the National Institute of Mental Health Research Domain Criteria project (RDoC-db).

The work involves defining data dictionaries for each data structure, cleaning and formatting data, and uploading the data to the appropriate National Institute of Mental Health server. The data so shared will contribute to the building of a large information commons for RDoC that will permit analyses of large data sets that have more power to uncover new relationships among highly multivariate and dimensional data sets.


Keywords provided by Jamie Feusner, University of California, Los Angeles:
anorexia nervosa
anxiety
reward
recurrence
magnetic resonance imaging

Additional relevant MeSH terms:
Anxiety Disorders
Anorexia
Anorexia Nervosa
Mental Disorders
Signs and Symptoms, Digestive
Signs and Symptoms
Feeding and Eating Disorders