Evaluating the Effect of the STEP@STAH Semaglutide Protocol on the Physical Health Measures of Atypical Antipsychotic-Treated Patients

Launched by ST ANDREW'S HEALTHCARE · Dec 20, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called Semaglutide (Wegovy®) on weight management for patients who are taking certain antipsychotic medications, like clozapine or olanzapine, and are struggling with obesity. Many of these patients may find it hard to lose weight due to the side effects of their medications, which can increase appetite and reduce physical activity. The goal of the trial is to see if Semaglutide, along with dietary advice, exercise support, and psychological help, can help these patients lose weight and improve their overall health.

To participate in this study, individuals must be at least 18 years old and have a body mass index (BMI) of 35 or higher (or 32.5 if they belong to certain ethnic groups). They should also currently be receiving treatment with olanzapine or clozapine and be in a secure care setting, like a hospital. Participants will receive weekly injections of Semaglutide and have access to support for diet and exercise as part of their treatment plan. Throughout the trial, their progress will be closely monitored to see how well the treatment is working. This study aims to find out who benefits most from this therapy and help create better treatment guidelines for the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • BMI of 35.0 kg/m2 or above or BMI of 32.5 kg/m2 for people from South Asian, Chinese, other Asian, Middle Eastern, Black African or African-Caribbean family
• • Aged 18 or above
• • Able to give informed consent, as assessed by their RC. In the context of participation in this trial 'informed' consent includes having an understanding of the dietary and exercises changes needed for the treatment to be effective
• • Currently prescribed olanzapine or clozapine
• • Currently in an inpatient service
• • Sufficient level of English to read and understand the information sheet (may require verbal explanation from support from staff)
• Exclusion Criteria:
• • Aged 17 or under
• • Meet any of the contraindications, including hypersensitivity to the active substance or to any of the excipients
• • Pregnant or likely to become pregnant
• • Diagnoses of dementia or Huntington's disease
• • On a PICU/acute ward
• • Discharge anticipated to be in 6 months' time or less