Clinical Study Evaluating Pharmacogenomics-informed Pharmacotherapy Versus Dosing as Usual in Psychiatric Disorders
The PSY-PGx study is investigating if tailored medication choices, based on an individual's genetic makeup, can lead to better outcomes for people living with mood, anxiety, or psychotic disorders. Many common psychiatric medications don't work well for everyone, partly because people process medicines differently based on their genes. This research aims to see if genetic testing can help doctors pick the right medication and dose more effectively, reducing side effects and improving treatment success. It's a 24-week trial comparing this genetic-guided approach to typical prescribing methods, involving thousands of patients across different centres.
At a glance
What is this study about?
When you're dealing with mental health conditions like depression, anxiety, or psychosis, finding the right medication that works well with minimal side effects can sometimes be a challenge. That's because everyone's body is unique, and how we process medicines can differ. Part of this difference comes down to our genes, which play a role in how our bodies handle medications.
This study, called PSY-PGx, is exploring a new approach called 'pharmacogenetics'. It involves looking at specific genes to understand how your body might react to certain psychiatric medications. The idea is that if doctors know this information beforehand, they might be able to choose a medication and dose that's more likely to be effective for you and less likely to cause unpleasant side effects. This could lead to a more personalised and effective treatment journey.
Currently, doctors often use a 'trial and error' approach to prescribing. This study aims to see if using genetic information can improve upon that standard method. It's a large, international research project that will compare this 'genetics-informed' way of prescribing against the usual way, over a period of 24 weeks. The goal is to gather strong evidence to show whether this personalised approach truly benefits patients in real-world healthcare settings.
Key takeaways
- Exploring if genetic testing can personalise psychiatric medication choices.
- A 24-week study for people with mood, anxiety, or psychotic disorders.
- Compares genetic-guided treatment to usual care.
- Aims to reduce side effects and improve treatment effectiveness.
- Participants aged 16-70 who are starting specific new medications.
- Participation is voluntary and you can withdraw anytime.
Who may be eligible?
This study is looking for people aged between 16 and 70 who are currently receiving treatment for mental health conditions. To be eligible, you must have a diagnosis of a mood disorder (like major depression or bipolar disorder in a depressive phase), an anxiety disorder (like panic disorder or generalised anxiety), or a psychotic disorder (like schizophrenia or schizoaffective disorder).
Your condition needs to be at least moderately severe at the time of joining the study. You also need to have tried at least one psychiatric medication in the past that didn't work well for you, either because it wasn't effective enough or you experienced side effects that made you stop taking it.
Furthermore, you must be about to start, or have recently (within the last two weeks) started, a specific new medication. For mood or anxiety disorders, this new medication would be sertraline or escitalopram. For psychotic disorders, it would be aripiprazole or risperidone. You also need to be able to understand the study information and be willing to provide written consent to take part.
- Are you between 16 and 70 years old?
- Do you have a diagnosis of a mood, anxiety, or psychotic disorder that is currently at least moderately severe?
- Have you tried at least one psychiatric medication before that didn't work well or caused too many side effects?
- Are you about to start (or have you recently started) sertraline, escitalopram, aripiprazole, or risperidone?
- Are you currently receiving mental health treatment (in hospital or as an outpatient)?
- Are you able to understand the study details and give your written consent to participate?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, it will last for 24 weeks. You will be one of two groups: one where medication choices are guided by genetic testing, and another where medication is prescribed as usual. Neither you nor your doctor will know which group you are in, to ensure unbiased results. You will have regular appointments for assessments and check-ups during this period. The specific number of visits and exact assessments will be explained in detail by the study team. You'll continue to receive your medication as part of your treatment plan, and your progress will be carefully monitored. The study will look at how well your medication is working and if you experience any side effects. You are free to withdraw from the study at any time.
Potential risks and benefits
Locations (9)
- SUNY Upstate Medical University, Department of Psychiatry and Behavioural SciencesSyracuse, United States· Not yet recruiting
- University Hospital Bonn, Department of Psychiatry and PsychotherapyBonn, Germany· Recruiting
- Ludwig-Maximilian University, University Hospital, Institute of Psychiatric Phenomics and Genomics (IPPG)München, Germany· Recruiting
- Parnassia Psychiatric Institute, Department of PsychiatryAmsterdam, Netherlands· Recruiting
- Maastricht University, Department of Psychiatry and NeuropsychologyMaastricht, Netherlands· Recruiting
- Babeş-Bolyai University, Department of Clinical Psychology and PsychotherapyCluj-Napoca, Romania· Recruiting
- University of Belgrade, Faculty of PharmacyBelgrade, Serbia· Recruiting
- Fundació Clínic per a la Recerca Biomèdica, Department of Psychiatry and Psychology, Hospital ClínicBarcelona, Spain· Recruiting
- King's College, Institute of Psychiatry, Psychology & NeuroscienceLondon, United Kingdom· Recruiting
Common questions
What is 'pharmacogenetics'?
Pharmacogenetics is the study of how your genes affect your body's response to medicines. It helps predict which medications might work best for you and with fewer side effects, based on your unique genetic makeup.
Will I know if I'm getting the personalised treatment?
No, neither you nor your doctor will know if your treatment is specifically guided by genetic testing or if you are receiving standard care. This is a common practice in research called 'blinding' to make sure the results are as fair and accurate as possible.
Do I have to stop my current medication to join?
The study is for people who are about to switch to, or have very recently started, specific new medications (sertraline, escitalopram, aripiprazole, or risperidone) because their previous treatment wasn't working well.
What kind of tests will I have?
You will likely have health check-ups and assessments to monitor your condition and how you respond to medication. If you're in the genetic-guided group, you would have a genetic test, usually a simple blood test, to get your genetic information.
What if I want to leave the study early?
You are completely free to leave the study at any time, for any reason. Your decision will not affect your ongoing medical care or relationship with your healthcare team.
How to find out more
Roos van Westrhenen, Professor (MD&PhD)
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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