NCT03471806

Brief Summary

This study will assess the role of dopamine responses to food reward in Bulimia Nervosa patients, by performing simultaneous Positron Emission Tomography (PET) and Magnetic Resonance (MR) scanning. The dopamine response will be measured before and after treatment, and will be compared to healthy controls.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 16, 2018

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

March 5, 2018

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 21, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

March 21, 2018

Status Verified

March 1, 2018

Enrollment Period

2 years

First QC Date

March 5, 2018

Last Update Submit

March 13, 2018

Conditions

Bulimia NervosaFood Reward

Keywords

Bulimia NervosaEating disorderDopamineFoodRewardPositron Emission TomographyMagnetic ResonanceMetabolic hormones

Outcome Measures

Primary Outcomes (2)

  • Dopamine release to food reward in Bulimia Nervosa patients compared to healthy controls

    Comparison of dopamine release to food reward between Bulimia Nervosa patients and healthy controls. Dopamine release is defined as changes in \[18F\]-Fallypride binding potential in the food reward condition, with a kinetic linearized simplified reference region model (LSSRM) model.

    Continuously over 225 minutes after onset scanning; at baseline (before onset treatment of patients)

  • Change in dopamine release to food reward in Bulimia Nervosa patients before and after treatment

    Comparison of dopamine release to food reward before and after inpatient treatment for Bulimia Nervosa. Dopamine release is defined as changes in \[18F\]-Fallypride binding potential in the food reward condition, with a kinetic linearized simplified reference region model (LSSRM) model.

    Continuously over 225 minutes after onset scanning; before and after inpatient treatment

Secondary Outcomes (1)

  • Composite measure of metabolic hormone levels

    5 minutes before onset scanning and 45, 105, 165, 180, 195, 210 and 225 minutes after onset scanning

Study Arms (2)

Bulimia Nervosa patients

EXPERIMENTAL

Bulimia Nervosa patient group: Assessment of dopamine release to food reward at baseline (before treatment) and to food reward after treatment.

Behavioral: Food reward at baselineBehavioral: Food reward after treatment

Healthy controls

EXPERIMENTAL

Healthy control group: Assessment of dopamine release to food reward at baseline, for comparison with Bulimia Nervosa patients.

Behavioral: Food reward at baseline

Interventions

Food reward at baselineBEHAVIORAL

Exposure to a combination of anticipatory (viewing high-calorie food images) and consummatory food reward (drinking sips of chocolate milkshake), at baseline.

Bulimia Nervosa patientsHealthy controls
Food reward after treatmentBEHAVIORAL

Exposure to a combination of anticipatory (viewing high-calorie food images) and consummatory food reward (drinking sips of chocolate milkshake), at the end of inpatient treatment.

Bulimia Nervosa patients

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Diagnosed with Bulimia Nervosa based on DSM-5 criteria;
  • Admission for inpatient treatment;
  • Female (on hormonal contraception);
  • Dutch-speaking;
  • Right-handed;
  • Body Mass Index (BMI) of 18.5 - 25 kg/m².

You may not qualify if:

  • Medical, neurological or other psychiatric disorders;
  • Use of psychotropic medication in past 6 months;
  • Use of cannabis or other drugs of abuse in past 12 months;
  • Lactose-intolerance or food allergies;
  • Vegetarian diet;
  • Smoking;
  • Consumption of more than 7 alcoholic units per week;
  • Exposure to a significant amount of ionizing radiation in past 12 months;
  • Claustrophobia;
  • Contra-indications for Magnetic Resonance Imaging;
  • Pregnancy.
  • Healthy control participants:
  • Healthy females (on hormonal contraception);
  • Dutch-speaking;
  • Right-handed;
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitaire ziekenhuizen Leuven

Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

Bulimia NervosaFeeding and Eating Disorders

Condition Hierarchy (Ancestors)

Mental DisordersSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Lukas Van Oudenhove, Prof. dr.

    Universitaire Ziekenhuizen KU Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 5, 2018

First Posted

March 21, 2018

Study Start

February 16, 2018

Primary Completion

February 1, 2020

Study Completion

May 1, 2020

Last Updated

March 21, 2018

Record last verified: 2018-03

Locations

BE(1)