Use of Mysimba in Patients With Weight Regain After Bariatric Surgery

Launched by ZUYDERLAND MEDISCH CENTRUM · May 25, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the use of a medication called Mysimba (known as Contrave in the US) to help patients who have regained weight after bariatric surgery, like gastric bypass or sleeve gastrectomy. The goal is to see if taking Mysimba, along with a special program called the Back on Track (BOT) program, can help these patients lose at least 5% of their weight over 22 weeks. This is important because, while bariatric surgery is effective, many patients still face challenges with weight regain afterward.

To be eligible for this trial, participants must have had a BMI of 35 or higher before their surgery, have undergone a specific type of weight loss surgery, and have gained more than 5% of their lowest weight after surgery. The trial is open to adults aged 18 and older, regardless of gender. Participants can expect to receive support through the BOT program while taking Mysimba, and the study will closely monitor their progress. It's also important to note that certain medical conditions and medications may prevent individuals from joining the trial, as safety is a top priority.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • Anatomical or surgical abnormalities for which revisional surgery is indicated.
• • Use of the following medication Monoamino-oxidase inbibitors (MAO), selective serotonin reuptake inhibitor (SSRI), Tricyclic antidepressants (TCA), haloperidol, risperidone, opioids, antiarrhythmics, betablockers, antiviral medication (HIV)
• • Pregnancy or breastfeeding
• * Patients suffering from:
• • unregulated hypertension
• • a tumour in the central nervous system
• • severe liver failure
• • end stage kidney failure
• • Patients suffering from or with a history of insults
• * Patients with a history of:
• • bipolar disease
• • bulimia or anorexia nervosa
• • Patients withdrawing from alcohol or benzodiazepines
• • Patients who are not able to understand the informed consent form and patient information.