Active not recruitingNAINTERVENTIONAL

Semaglutide in Comorbid Schizophrenia Spectrum Disorder and Obesity

This study is investigating a new way to help people with schizophrenia spectrum disorders who are struggling with weight gain. Many individuals with these conditions take antipsychotic medications, which can lead to significant weight gain and related health problems. While metformin is often the first treatment tried, it doesn't work for everyone. This research will test if semaglutide, a medication approved for weight loss, can effectively help these individuals lose weight. Researchers will also look at how semaglutide affects blood sugar, heart health, general mood, and thinking skills. The aim is to find better ways to manage weight and improve overall health for those with schizophrenia spectrum disorders.

At a glance

Status

Active not recruiting

Phase

Sponsor

Centre for Addiction and Mental Health

Enrolment target

Start

25 May 2022

Estimated completion

01 Aug 2026

Schizophrenia Spectrum Disorders

What is this study about?

Many people living with conditions like schizophrenia spectrum disorder face an extra challenge: significant weight gain. This is often linked to the antipsychotic medications they need to manage their mental health. Being overweight or obese can lead to other serious health issues, such as heart problems and diabetes, and can sadly shorten life expectancy. Doctors already try to help with weight loss, often starting with a medication called metformin. While metformin is a good first step, it doesn't work for everyone, meaning many individuals still struggle to lose weight.

This study aims to find a new solution. It's looking at a medication called semaglutide, which belongs to a group of drugs that have been approved for weight loss and are also known to improve heart health. Semaglutide is given as a weekly injection, which can be more convenient for some people. The researchers want to see if semaglutide can help people with schizophrenia spectrum disorder who are overweight or obese and haven't found success with metformin, to lose weight.

Beyond just weight loss, the study will also explore how semaglutide might affect other aspects of health. This includes checking blood sugar levels, monitoring risk factors for heart disease, looking at mood and mental well-being, and even assessing thinking skills like memory and concentration. There's a growing idea that managing weight and improving overall metabolic health could also benefit these 'thinking' areas. By participating, you could help us understand if semaglutide offers a broad range of benefits for individuals with schizophrenia spectrum disorders.

Key takeaways

This study is for adults with schizophrenia spectrum disorders who are overweight or obese.
It tests a drug called semaglutide for weight loss, especially if metformin hasn't worked.
Researchers will also look at how semaglutide affects blood sugar, heart health, mood, and thinking.
Participation involves weekly injections (either semaglutide or a placebo) and regular health checks.
The goal is to find better ways to manage weight and improve overall health for people with these conditions.

Who may be eligible?

To join this study, you need to be an adult between 18 and 70 years old and have a diagnosis of schizophrenia spectrum disorder, major depression with psychotic features, or bipolar disorder. You should also be taking antipsychotic medication and have been on a stable dose for at least three months. Importantly, you must be overweight or obese, which means your Body Mass Index (BMI) should be 30 or higher. If your BMI is between 27 and 30, you could still be eligible if you have another weight-related health issue, such as high blood pressure or sleep apnea.

A key part of joining is that you must have tried metformin for weight loss in the past and found it either didn't work well enough (you didn't lose at least 5% of your body weight after 16 weeks) or you couldn't tolerate it. You should also not be taking metformin for at least one week before starting the study. The study cannot include people with certain serious health conditions, such as severe liver or kidney problems, uncontrolled heart disease, or a history of specific thyroid cancers or pancreatitis.

Also, if you are a woman who could become pregnant, you must be using reliable contraception. You cannot be pregnant or breastfeeding. People with Type 1 or uncontrolled Type 2 diabetes (indicated by a high HbA1c test) will not be able to participate. If you've recently had major surgery or taken certain other weight-loss medications or specific blood thinners, you might also not be eligible.

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 between 18 and 70 years old?
Do you have a diagnosis of schizophrenia spectrum disorder, major depression with psychotic features, or bipolar disorder?
Are you currently taking antipsychotic medication?
Are you overweight or obese (BMI of 30 or higher, or 27+ with other weight-related health issues)?
Have you tried metformin for weight loss in the past and found it didn't work well or you couldn't tolerate it?
Are you free from severe liver, kidney, or uncontrolled heart conditions?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will be given either semaglutide or a placebo (a dummy treatment without active medication) as a weekly injection. The study will involve regular visits to the clinic where researchers will measure your weight, take blood samples to check your blood sugar and heart health, and ask you questions about your mood, thinking abilities, and general lifestyle. You will also have follow-up appointments to track your progress and any changes over time. Your participation will last for a specific period, though the exact duration isn't detailed here, it typically involves weeks or months of treatment and monitoring, followed by a final assessment. You will be closely supported by the study team throughout.

Potential risks and benefits

Participating in this study might offer you the potential benefit of losing weight and improving your general health, including blood sugar control and heart health, which could lead to a better quality of life. There's also the chance you might gain a better understanding of your health. However, like any medication, semaglutide can have side effects, which may include nausea, vomiting, or other stomach issues. You will be closely monitored for any side effects. It's important to remember that you will be randomly assigned to either receive semaglutide or a placebo, meaning you might not receive the active drug. You are completely free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Centre for Addiction and Mental Health
Verified postcode
Toronto, Canada

Common questions

What is semaglutide?

Semaglutide is a medication that helps with weight loss and can also improve blood sugar levels. It's given as a weekly injection.

Why are people with schizophrenia spectrum disorders being studied for weight loss?

Antipsychotic medications, often used for these conditions, can cause significant weight gain, leading to other serious health problems. This study aims to find better solutions for this issue.

What is a placebo?

A placebo is a 'dummy' treatment that looks like the real medication but contains no active drug. It helps researchers compare the effects of the actual medication.

Will I know if I'm getting semaglutide or a placebo?

No, this is a 'blinded' study, meaning neither you nor the study team will know whether you are receiving semaglutide or the placebo. This helps ensure fair results.

What happens if semaglutide doesn't work for me during the study?

The study team will monitor your progress closely. If you're not responding well or experience any issues, they will discuss your options with you, and you can withdraw at any time.