Active not recruitingPHASE4INTERVENTIONAL

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

This study explores if a medication called semaglutide (Wegovy®) can help people who have gained a lot of weight because of their antipsychotic medicines, like olanzapine or clozapine. We know these medicines can increase appetite and affect metabolism, sometimes leading to obesity, especially for those with limited activity. The study combines weekly semaglutide injections with ongoing support for healthy eating, exercise, and psychological well-being. Researchers want to see if this combination can effectively reduce weight, similar to how it helps people whose weight gain isn't medicine-related. The goal is to find out who benefits most and create better guidelines for managing weight in this situation.

At a glance

Status

Active not recruiting

Phase

PHASE4

Sponsor

St Andrew's Healthcare

Enrolment target

Start

01 Jan 2025

Estimated completion

30 Dec 2027

Obesity and Obesity-related Medical Conditions Psychiatric Disorders

What is this study about?

Many people who take certain mental health medications, like olanzapine or clozapine, find they gain a lot of weight. This isn't just about appetite; sometimes, these medicines can change how your body handles food and energy. On top of that, if someone has limited opportunities for physical activity, managing weight becomes even harder. When weight gain is significant, it can lead to health problems linked to obesity.

This study is looking at a medicine called semaglutide, also known as Wegovy®. This medicine has already been approved to help with weight loss for many adults, when used with a healthy diet and exercise. The main question this study wants to answer is whether semaglutide, combined with advice on healthy eating, regular exercise, and emotional support, can help people reduce the weight they've gained due to their antipsychotic medication. The overall aim is to find effective ways to manage this challenging side effect.

Researchers will carefully monitor participants' weight, activity levels, and diet throughout the study. They want to understand who benefits most from this approach. The information gathered will be used to develop better ways to support people taking these medications and help guide doctors on how to manage weight gain in the future. It's important to remember that this study is not simply about taking a pill; it's about a combination of medical support and lifestyle changes.

Key takeaways

This study explores a new way to manage weight gained from mental health medicines.
It combines a weekly injection (semaglutide/Wegovy®) with healthy lifestyle support.
The goal is to help people reduce weight and improve their health.
Participation involves ongoing monitoring of weight, diet, and activity.
The findings will help create better weight management guidelines for similar patients.

Who may be eligible?

To be considered for this study, you would generally need to be an adult (18 or over) who is currently receiving care at St Andrew's Healthcare and taking either olanzapine or clozapine. A key factor is your body mass index (BMI), which is a measure of weight in relation to height. You would typically need a BMI of 35 or above, although for people from certain ethnic backgrounds, a BMI of 32.5 or above might be considered.

It's also important that you can understand what the study involves and agree to take part, including making diet and exercise changes. You'll need to be able to read and understand the study information.

However, there are reasons you might not be able to join. For example, if you are pregnant or likely to become pregnant, or if you have certain health conditions like dementia or Huntington's disease. If you are in a very short-term care ward (PICU/acute ward) or expected to leave St Andrew's within six months, you also wouldn't be eligible. Also, if you know you are allergic to semaglutide or any of its ingredients, you couldn't take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you currently taking olanzapine or clozapine?
Do you have a BMI generally over 35 (or 32.5 for specific ethnic groups)?
Are you currently an inpatient at St Andrew's Healthcare?
Can you understand information about the study and commit to lifestyle changes?
Are you NOT pregnant or likely to become pregnant?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive weekly injections of a medicine called semaglutide (Wegovy®). This will be alongside regular advice and support for healthy eating and exercise, which will be part of your overall care plan. You'll also receive support for your mental well-being throughout the study.

Researchers will keep a close eye on your progress, monitoring things like your weight, how active you are, and your diet. This will happen over a period of time, which will be explained in more detail if you are interested in joining. The study is designed to see the long-term effects of this treatment, so it will involve ongoing assessments and support.

Potential risks and benefits

Taking part in this study could potentially help you manage the weight you've gained due to your medication, which might improve your overall physical health and well-being. However, like all medicines, semaglutide can have side effects, which you would be fully informed about before deciding to participate. There's also no guarantee that the treatment will work for everyone. You are free to withdraw from the study at any time, for any reason, without it affecting your usual care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

St Andrew's Healthcare
Verified postcode
Northampton, United Kingdom

Common questions

What is semaglutide (Wegovy®)?

Semaglutide is a medicine that helps manage blood sugar and appetite, which can lead to weight loss. It's given as a weekly injection.

Why is this study focused on antipsychotic medication?

Antipsychotic medications can cause weight gain as a side effect, and this study aims to find an effective way to help people manage this specific weight gain.

Will I have to change my diet and exercise?

Yes, the study involves combining the medication with advice and support for healthy eating and exercise, as these are key to weight loss.

How long will the study last?

The study aims to look at the long-term effects, so it will involve ongoing participation, with the full duration explained if you are eligible.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time, for any reason, and it will not affect your regular medical care.