An interventional study of Personalised medication advice based on pharmacogenetic testing in Mood Disorders, Anxiety Disorders and Psychotic Disorders, sponsored by Parnassia Groep. Recruiting at 9 sites in 7 countries. Open to participants aged 16 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-06-02.
Sponsored by Parnassia Groep · Not applicable, Interventional, and Treatment
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.
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.
561 studies on the registry are indexed under Mood Disorders; 105 are open to participants now.
This study's planned enrollment of 2,500 is above the median of 80 across 419 interventional studies indexed under Mood Disorders.
Browse Mood Disorders studies →Parnassia Groep is the lead sponsor of 5 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Severe somatic comorbidities as reported in the subject's medical history or based on clinical chemistry/electrocardiography () results up to six months ago. If any of these comorbidities is detected on the basis of physical examination and/or clinical chemistry and/or ECG at the screening visit, participation is not possible.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This is the intervention group. All patients will be treated according to a personalised medication recommendation based on the results of pharmacogenetic testing, following the prespecified dosing guideline. Prescribing physicians will prescribe one of the predefined drugs and will be unblinded for genotype and the resulting metabolisation phenotype.
Other: Personalised medication advice based on pharmacogenetic testing
This is the control group. In this group, prescribing physicians will also prescribe one of the predefined drugs, but will remain blinded to their patients' genotype and resulting metabolism phenotype for the duration of their participation in the study. After the study, patients in the control group will also be given their pharmacogenetic profile, which will make it possible to personalise their medication if necessary.
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 recovery, as assessed using the Patient Recovery Assessment scale - Domains and Stages (RAS-DS).
A standardised self-report tool that measures mental health recovery as defined by the client. Repeated use of the instrument makes it possible to detect change over time. Score range 38-152. Higher scores mean a better outcome.
Time frame: 24 weeks
Response Mood Disorder, defined as a 50% point reduction in the following scale:
Structured interview Guide for the Hamilton Depression Scale (SIGH-D) for depressive disorder. Score range 0-52. Higher scores mean a worse outcome.
Time frame: 24 weeks
Response Anxiety Disorder, defined as a 50% point reduction in the following scale:
Structured interview Guide for the Hamilton Anxiety Scale (SIGH-A) for anxiety disorder. Score range 0-56. Higher scores mean a worse outcome.
Time frame: 24 weeks
Response Psychotic Disorder, defined as a 50% point reduction in the following scale:
Positive and Negative Symptom Scale (PANSS) for psychotic disorder. Score range 30-210. Higher scores mean a worse outcome.
Time frame: 24 weeks
Symptomatic Remission Mood Disorder, defined as:
SIGH-D score of 7 or less. Score range 0-52. Higher scores mean a worse outcome.
Time frame: 24 weeks
Symptomatic Remission Anxiety Disorder, defined as:
SIGH-A score of 7 or less. Score range 0-56. Higher scores mean a worse outcome.
Time frame: 24 weeks
Symptomatic Remission Psychotic Disorder, defined as:
PANSS score of 57 or less. Score range 30-210. Higher scores mean a worse outcome.
Time frame: 24 weeks
Burden of side effects, as measured by:
Frequency, Intensity and Burden of side effects ratings (FIBSER). Score range 0-18. Higher scores mean a worse outcome.
Time frame: 24 weeks
Side effects, as measured by:
Udvalg for Kliniske Undersogelse - Side Effects Rating Scale (UKU-SERS). Score range 0-135. Higher scores mean a worse outcome.
Time frame: 24 weeks
General wellbeing, as measured by:
The 5-level EQ-5D version (EQ-5D-5L). Score range 5-25. Higher scores mean a worse outcome. Visual Analog Scale (VAS)-score 0-100. A higher score means a better outcome.
Time frame: 24 weeks
Psychosocial functioning, as measured by:
Functioning Assessment short test (FAST). Score range 0-72. Higher scores mean a worse outcome.
Time frame: 24 weeks
Passive behavioral monitoring using the BeHAPP mobile application.
The BEHAPP mobile application will be used to collect passive, social behavioural data as additional outcome measure that has been shown to be of value in predicting relapse/recurrence. Once the application is installed and initialised, it passively collects (meta)data on phone call activity, Bluetooth devices and WiFi access points in the participant's immediate environment, location updates and mobile application usage.
Time frame: 24 weeks
Plan to share: No
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Parnassia Groep