oradrenergic control of neurobehavior in human binge-eating disorder and obesity
- Conditions
- Diagnostical and Statistical Manual of Mental Disorders Fifth Edition (DSM-5) 307.51: Binge-Eating Disorder (ICD-10: F50.8)E66Obesity
- Registration Number
- DRKS00029367
- Lead Sponsor
- Forschungsbereich Verhaltensmedizin, Integriertes Forschungs- und Behandlungszentrum AdipositasErkrankungen, Klinik und Poliklinik für Psychosomatische Medizin und Psychotherapie, Universitätsmedizin Leipzig
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 80
1. The OB+BED sample will consist of individuals with BED according to DSM-5 as determined through the Eating Disorder Examination interview and BMI 30.0-45.0 kg/m2.
2. The OB-BED sample will consist of individuals without BED and with BMI 30.0-45.0 kg/m2.
3. The NW sample will include individuals without BED and with BMI 18.5-25.0 kg/m2.
Additional general inclusion criteria are:
4. Informed consent
5. Sufficient German language skills and a feasible commute to the medical campus of Leipzig University
1. Serious somatic conditions (e.g., neurological disorders, stroke, head injury, manifest diabetes, severe hypertension)
2. Serious mental disorders (e.g., psychotic disorder, suicidality, substance use disorder, ADHD, depression, anxiety disorder), as determined by the clinical interview Mini-DIPS, and developmental or intellectual disability
3. Medication acting on the central nervous system; use of anorexic medication or other interventions for weight loss in the past 6 months
4. Ongoing psychotherapy; past or present history of alcohol misuse or the use of illegal drugs (ensured by urine screening)
5. Pregnancy or breast-feeding females, or persons being held by judicial or official order, or other contraindications for the use of radiotracers according to the radiation protection legislation; Women of child bearing potential will be interviewed regarding a potential pregnancy and in addition urine pregnancy testing will be performed prior to the administration of [11C]MRB using a standard kit.
6. MRI contraindications such as ferromagnetism (e.g., pacemaker, drug-delivery systems), or claustrophobia; there will be no application of contrast media
7. To avoid interference of ethanol with the radiopharmaceutical, the use of any alcoholic beverages and/or other compounds that include alcohol is prohibited for at least 48 hours prior to PET investigation. The use of medical drugs which inhibit the reboxetine-degrading liver enzyme (such as ketoconazol or fluvoxamine), which interact with reboxetine (e.g., monoamine-oxidase inhibitors or lorazepam), or which may displace [11C]MRB from the binding site (such as atomoxetine or nisoxetine) is excluded as well.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Regional distribution volume as an index of noradrenaline transporter (NAT) availability in the brain at baseline (OB+BED, OB-BED, NW) and before and after intervention (OB+BED, OB-BED)
- Secondary Outcome Measures
Name Time Method Resting-state and task-related fMRI and behavioral data; clinical interviews and self-report questionnaires on eating behavior, emotion regulation, mental and physical health, and quality of life; neuropsychological tests