Ongoing, recruitingTherapeutic use (Phase IV)Interventional

Safety and efficacy of olanzapine treatment in psychosis: Effect of genetic and epigenetic factors – covariates of treatment response

This study is investigating olanzapine, a medicine used to treat psychosis. Researchers want to understand why some people respond better to olanzapine than others, and why some experience side effects. They are particularly interested in how a person's genes (things they inherit) and 'epigenetic factors' (how their genes are used) might play a role in this. The study is for adults over 18 and looks at how olanzapine is used in everyday medical practice (this is called a Phase IV study). By understanding these factors, doctors hope to tailor treatments more effectively in the future, giving patients the best chance of feeling better with fewer unwanted effects.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Masarykova Univerzita

Enrolment target

200

Start

04 May 2023

Psychoses

What is this study about?

This research study is looking closely at a common medicine called olanzapine, which is used to help people who experience psychosis. Psychosis is a serious mental health condition that affects how a person thinks, feels, and behaves, sometimes causing them to lose touch with reality.

The main aim of this study is to understand why olanzapine works well for some people, but not as well for others, and why some people get more side effects. The researchers believe that tiny differences in our genes (the instructions that make us who we are) and other natural processes in our bodies might influence how we react to the medicine. By looking at specific genes, they hope to find clues that could help predict who will benefit most from olanzapine and who might need a different approach.

This is a 'Phase IV' study, which means it’s looking at a medicine that's already approved and in use. It's about understanding its real-world effects, rather than testing if it works for the first time. The results could help doctors personalise treatment for psychosis in the future, making sure each patient gets the most effective care with the fewest unwanted side effects.

Key takeaways

This study explores how olanzapine works for people with psychosis.
It aims to understand if genes or body processes affect treatment success and side effects.
The research could lead to more personalised psychosis treatments in the future.
It's an 'observational' study of an existing medicine.
Open to adults aged 18 and over, both men and women.

Who may be eligible?

To be considered for this study, you need to be an adult, 18 years old or older. The study is open to both men and women.

More specific details about health conditions, other medicines you might be taking, or previous treatments you've had will also be important. The study team will check all these details carefully to make sure the study is a good fit for you and that taking part would be safe.

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 being treated for psychosis?
Are you prepared to potentially receive olanzapine as part of your treatment?
Are you willing to have samples taken (like blood) for genetic analysis?
Are you able to attend regular appointments for assessment?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive olanzapine as your treatment. The study team will regularly check how you are responding to the medication, including looking at your symptoms and any side effects you might experience. They will use special questionnaires to measure your symptoms and a scale to track side effects.

They will also collect information about your genes and other body processes, likely through blood tests. Assessments will happen on specific days, such as day 14 and day 28 after starting treatment. The study will also track if you stop taking olanzapine and why. The total length of your participation will depend on the study schedule for your treatment and assessments.

Potential risks and benefits

Participating in this study might offer the benefit of receiving ongoing care for your psychosis as part of a structured research programme. You could also contribute to important medical knowledge that helps others in the future. As with any medication, olanzapine can have side effects, and the research team will carefully monitor these. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

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Unverified
Czechia

Common questions

What is psychosis?

Psychosis is a mental health condition where a person might have difficulty telling what's real from what's not. They might see or hear things others don't, or have unusual beliefs.

What is olanzapine?

Olanzapine is a medicine often used to help manage symptoms of psychosis.

What does 'genes' mean in this study?

Genes are like instruction manuals inside our bodies. This study wants to see how tiny differences in these instructions might affect how you react to olanzapine.

What is a 'Phase IV' study?

A Phase IV study looks at a medicine that's already approved and used by doctors. It helps us learn more about it in real-life situations, like how different people respond.

Will I get special treatment if I join?

You will receive regular medical care for your psychosis, and the study will carefully monitor your treatment with olanzapine.