Applying Mysimba in patients with weight regain after bariatric surgery

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 160

Inclusion Criteria

To be eligible to participate in this study, a subject must meet all of the
following criteria:
• 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 Criteria

A potential subject who meets any of the following criteria will be excluded
from participation in this study:
• 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:
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
• Patients withdrawing from alcohol or benzodiazepines
• Patients who are not able to understand the informed consent form and patient
information.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary objective is to study the effect of naltrexone/bupropion(Mysimba)<br /><br>in combination with the BOT module compared to the regular BOT module for 22<br /><br>weeks, the duration of the regular BOT, on weight loss in patients with weight<br /><br>regain after bariatric surgery. </p><br>

Secondary Outcome Measures