Testing Mysimba for weight regain after bariatric surgery
Tests Mysimba dose levels in adults regaining weight after gastric bypass or sleeve surgery.
Plain-language title generated from the registry record
Registry title: Applying Mysimba in patients with weight regain after bariatric surgery
Key facts
- Where
- Heerlen, NetherlandsSee the site
- Phase
- Phase 4
Where in Netherlands
- Zuyderland Medisch Centrum StichtingHeerlen, NetherlandsNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Zuyderland Medisch Centrum Stichting
- Trial code
- NCT04902625EU 2024-516645-39-01
- Record updated
- 17 January 2025
- Original description
Dose response of Mysimba after Roux-and-Y gastric bypass or Gastric Sleeve surgeryRead full original descriptionShow less
Applying Mysimba in patients with weight regain after bariatric surgery
Dose response of Mysimba after Roux-and-Y gastric bypass or Gastric Sleeve surgery
Inclusion: Patient is ≥18 and <75 years old; BMI before surgery was ≥ 35.0 kg/m2; Patient has undergone a primary banded/non-banded Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG); Gaining more than 5% weight after reaching plateau phase of lowest weight To be eligible to participate in the control patient cohort for measuring bupropion and hydroxybupropion serum levels a subject must meet all of the following criteria: • Patient is ≥18 and <75 years old • Patient is obese (BMI > 30 kg/m2) • Patient on successful Mysimba steady maintenance dose.
Exclusion: Anatomical or surgical abnormalities for which revisional surgery is indicated; Patients with excessive use of alcohol or drugs; Use of the following medication Monoamino-oxidase inhibitors (MAO), selective serotonin reuptake inhibitor (SSRI), Tricyclic antidepressants (TCA), haloperidol, risperidone, opioids, antiarrhythmics, betablockers, antiviral medication (HIV); Patients suffering from: o unregulated hypertension o a tumour in the central nervous system o severe liver failure o end stage kidney failure; Patients suffering from or with a history of insults; Patients with a history of: o bipolar disease o bulimia or anorexia nervosa; Pregnancy or breastfeeding; Patients withdrawing from alcohol or benzodiazepines; Patients who are not able to understand the informed consent form and patient information.