At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Personalised medication advice based on pharmacogenetic testing (other)
- How long the study runs
- Study runs about 43 months (dates as stated)
- About the drug or intervention
- Personalised medication advice based on pharmacogenetic testing — other: Pharmacogenetic genotyping provides personalised medication advice on dosage and choice of currently available and legally approved medication based on the patient's pharmacogenetic profile
- Patient visit burden
- Not specified by the sponsor
In plain English
This study looks at whether using a genetic test (pharmacogenomics, which checks how your genes affect the way you respond to medicines) can help doctors choose the best dose of psychiatric medicine, compared with the usual way of deciding doses. It is for people aged 16 to under 70 with mood, anxiety or psychotic disorders who have not responded well to at least one previous psychiatric medicine. It is sponsored by Parnassia Groep.
Who can take part
- Aged 16 to under 70
- Have depression (including bipolar depression) of at least moderate severity, and/or an anxiety disorder (panic disorder or generalised anxiety disorder) of at least moderate severity, and/or a psychotic disorder (schizophrenia or schizoaffective disorder) of at least moderate severity
- Have not responded well enough to at least one psychiatric medicine in the past, or had to stop it because of side effects
- Are switching (or switched in the last 2 weeks) to a new medicine: sertraline or escitalopram for mood or anxiety disorders, or aripiprazole or risperidone for psychotic disorders
- Currently receiving psychiatric treatment as an inpatient or outpatient
- Able to understand the study and give written consent, including consent to use your medical records
- Own a mobile phone (Android or iOS) for monitoring during the study
Who may not be able to
- Have had a genetic test for medicines before (pharmacogenomic testing)
- Have never taken psychiatric medicine before
- Have severe physical health problems, such as liver disease, kidney disease, diabetes, or a heart problem (prolonged QT interval) found on tests or examination
- Have alcohol or drug misuse or dependence (smoking/nicotine is allowed)
- Regularly take five or more medicines (including over-the-counter, prescription, traditional or complementary medicines)
- Cannot use the mobile phone app
- Are pregnant or breastfeeding
What taking part involves
- • Your psychiatric medicine dose will be decided either using a genetic test (pharmacogenomics) or in the usual way
- • If you have a mood or anxiety disorder, the medicine will be sertraline or escitalopram; if you have a psychotic disorder, it will be aripiprazole or risperidone
- • Passive monitoring using an app on your own mobile phone (Android or iOS)
Time commitment: Not stated — ask the trial team (the study involves ongoing psychiatric treatment, a genetic test, use of a mobile phone app for monitoring, and checks such as a physical examination, blood tests and a heart trace (electrocardiogram, ECG) at screening).
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 16 Years to 70 Years
- Who
- All
- Number of participants
- 2,500
- Started
- 2023-02-23
- Last checked
- 2026-05
Plain English Summary
What is this study?
- • Testing a new treatment for mood disorders
- • NA - 2,500 participants
- • A 24-week, patient- and rater-blinded, two-arm, parallel-group controlled, and multi-centre randomized clinical trial (RCT) to establish the benefits of pharmacogenetics-informed pharmacotherapy versus dosing as usual (DAU) in psychiatric patients suffering from mood, anxiety, or psychotic disorders
Who can take part?
- • Ages 16 Years to 70 Years
- • Diagnosed with mood disorders
Where?
- • London - King's College, Institute of Psychiatry, Psychology & Neuroscience
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
A 24-week, patient- and rater-blinded, two-arm, parallel-group controlled, and multi-centre randomized clinical trial (RCT) to establish the benefits of pharmacogenetics-informed pharmacotherapy versus dosing as usual (DAU) in psychiatric patients suffering from mood, anxiety, or psychotic disorders.
More detail
Effective pharmacotherapeutic treatments for mental disorders are available, but their effectiveness is limited by low compliance due to frequent side effects. This is partly due to patient heterogeneity in the genes encoding for drug-metabolising enzymes. Pharmacogenetic testing allows the assessment of person-specific genetic factors that are thought to predict clinical response and side effects. Recent studies have suggested that genotyping genes encoding drug-metabolizing enzymes may improve treatment efficacy and tolerability, potentially benefitting millions of patients. PSY-PGx is the first initiative to propose a large-scale non-industry sponsored clinical study that aims to demonstrate the clinical benefits and potential of the implementation of pharmacogenetics for psychiatric patients in existing medical settings. This is an international 24-week, patient- and rater-blinded, two-arm, parallel-group controlled, and multi-centre randomized clinical trial (RCT) to establish the benefits of pharmacogenetics-informed pharmacotherapy versus dosing as usual (DAU) in psychiatric patients suffering from mood, anxiety, or psychotic disorders.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 16 Years - 70 Years
- Who can join: All genders
Biomarkers mentioned
Treatment history
Treatments you must NOT have had:
- ✗ use of psychotropic medication (medication-naïve patients)
What the study is looking for
- ✓Currently receiving inpatient or outpatient psychiatric treatment.
- ✓To give written consent to the use and disclosure of clinical data from their medical records for the purpose of...
- ✓Age between ≥16 and \<70 years.
- ✓Ownership of a mobile phone (Android or iOS operation system) for passive monitoring.
Who cannot take part
- ✗Patients with a history of prior pharmacogenomic testing
- ✗Patients with no prior use of psychotropic medication (medication-naïve patients)
- ✗Liver disease defined as follows: Alanine-Aminotransferase (ALAT) \>70u/L
- ✗kidney disease: Estimated glomerular filtration rate (eGFR) \< 60ml/min/1.73m2
- ✗Diabetes: Blood glucose \> 11.1 mmol/L or twice a fasting glucose \> 7.0 mmol/L
See the full criteria
Where Is This Study? (1 UK site)
King's College, Institute of Psychiatry, Psychology & Neuroscience
London, United Kingdom
How to Get in Touch
Roos van Westrhenen, Professor (MD&PhD)
Sponsor contactCONTACT
Margriet Boerman, Contact person
Sponsor contactCONTACT
