Mood DisordersPSY-PGxNCT05656469
Clinical Study Evaluating Pharmacogenomics-informed Pharmacotherapy Versus Dosing as Usual in Psychiatric Disorders
A study testing Personalised medication advice based on pharmacogenetic testing in people with Mood Disorders and Anxiety Disorders, run by Parnassia Groep at 9 sites in 7 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 16 to 70 years
- Conditions the study is for
- Mood Disorders, Anxiety Disorders, Psychotic Disorders
- What is being tested?
- Personalised medication advice based on pharmacogenetic testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,500 participants
- Where
- 9 sitesin 7 countries
- Study dates
- 23 Feb 2023to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Suffer from a depressive episode (major depressive disorder and bipolar disorder (currently depressive episode)) (as assessed by the MINI International Neuropsychiatric Interview (M.I.N.I.) in agreement with Diagnostic and Statistical Manual (DSM-5 criteria) of at least moderate severity (assessed using the Structured Interview Guide for the Hamilton Depression Scale (SIGH-D) with a score of 14 or higher) and/or suffer from an anxiety disorder (panic disorder, generalised anxiety disorder) (as assessed by the M.I.N.I. in agreement with DSM-5 criteria) of at least moderate severity (assessed using the Structured Interview Guide for the Hamilton Anxiety Scale (SIGH- A) with a score of 18 or higher) and/or suffer from a psychotic disorder (schizophrenia and schizoaffective disorder) (as assessed by the M.I.N.I. in agreement with DSM-5 criteria) of at least moderate severity (assessed using the Positive and Negative Symptom Scale (PANSS) with a score of 75 or higher).
- Have had an inadequate response to at least 1 psychotropic treatment during their life-time. Inadequate response is defined as insufficient efficacy of a psychotropic treatment when dosed high enough and maintained long enough, or discontinuation of a psychotropic treatment due to AEs or intolerability.
- Are about to switch (or have switched within the last 2 weeks prior to first contact with an investigator) to sertraline or escitalopram (for patients with mood or anxiety disorders), or to aripiprazole or risperidone (for patients with psychotic disorders) due to an inadequate response to or intolerance of the current/ previous medication.
- Currently receiving inpatient or outpatient psychiatric treatment.
- Be able to understand the requirements of the study and provide written informed consent to participate in this study; a signed and dated informed consent form (ICF) will be obtained from each patient before participation in the study.
- To give written consent to the use and disclosure of clinical data from their medical records for the purpose of this study.
- Age between ≥16 and <70 years.
- Ownership of a mobile phone (Android or iOS operation system) for passive monitoring.
Who cannot join
- Patients with a history of prior pharmacogenomic testing
- Patients with no prior use of psychotropic medication (medication-naïve patients)
- Severe somatic comorbidities as reported in the subject's medical history or based on clinical chemistry/electrocardiography (ECG) 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.
- Liver disease defined as follows: Alanine-Aminotransferase (ALAT) >70u/L
- Renal 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
Show all 11Show fewer
- Cardiac disease: prolonged QT-interval.
- Alcohol and/or substance abuse and/or dependence (except nicotine)
- Polypharmacy defined as the routine use of five or more medications including over- the-counter, prescription and/or traditional and complementary medicines used by a patient (WHO 2019).
- Inability to use the mobile phone application
- Pregnant or breastfeeding women
Trial locations and contacts
9 sites in 7 countries. Contact the study team or a site near you to ask about taking part.
9 sites in 7 countries
Germany2 sites, 2 recruiting
- Recruiting
University Hospital Bonn, Department of Psychiatry and Psychotherapy
Bonn
Sarah Maywald, MD
Alexandra Philipsen, Prof. Dr.
- Recruiting
Ludwig-Maximilian University, University Hospital, Institute of Psychiatric Phenomics and Genomics (IPPG)
München
Urs Heilbronner, PhD
Urs Heilbronner, Dr.
Netherlands2 sites, 2 recruiting
- Recruiting
Parnassia Psychiatric Institute, Department of Psychiatry
Amsterdam
Roos van Westrhenen, Prof., +31 88-358339, r.vanwestrhenen@psyq.nl
Margriet Boerman, Contact Persob, +31-657940368, farmacogenetica@parnassiagroep.nl
- Recruiting
Maastricht University, Department of Psychiatry and Neuropsychology
Maastricht
Therese van Amelsvoort, Prof. Dr.
Therese van Amelsvoort, Prof. Dr.
United States1 site, 1 recruiting
- Not yet recruiting
SUNY Upstate Medical University, Department of Psychiatry and Behavioural Sciences
Syracuse, New York, 13210
Thomas Schulze, Prof. Dr.
Thomas Schulze, Prof. Dr.
Romania1 site, 1 recruiting
- Recruiting
Babeş-Bolyai University, Department of Clinical Psychology and Psychotherapy
Cluj-Napoca
Ramona Moldovan, Prof.
Ramona Moldovan, Prof.
Serbia1 site, 1 recruiting
- Recruiting
University of Belgrade, Faculty of Pharmacy
Belgrade
Marin Jukic, Dr.
Marin Jukic, Dr.
Spain1 site, 1 recruiting
- Recruiting
Fundació Clínic per a la Recerca Biomèdica, Department of Psychiatry and Psychology, Hospital Clínic
Barcelona
Natalia Elena Fares, PhD
Eduard Vieta, Prof. Dr.
United Kingdom1 site, 1 recruiting
- Recruiting
King's College, Institute of Psychiatry, Psychology & Neuroscience
London
Allan Young, Prof. Dr.
Allan Young, Prof. Dr.
About this study
Official title: A New Intervention for Implementation of Pharmacogenetics in Psychiatry
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.
Read the detailed description
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.
- Conditions
- Mood Disorders, Anxiety Disorders, Psychotic Disorders
- Being tested
- Personalised medication advice based on pharmacogenetic testing
- Keywords
- Pharmacogenetics
- Medical subject headings
- Mood Disorders, Anxiety Disorders, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalised medication advice based on pharmacogenetic testingOther
Pharmacogenetic genotyping provides personalised medication advice on dosage and choice of currently available and legally approved medication based on the patient's pharmacogenetic profile
| Study group | Role | What they receive |
|---|---|---|
| PSY-PGx Group | Experimental | 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. Receives: Other: Personalised medication advice based on pharmacogenetic testing |
| Dosing as usual (DAU) group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 weeks
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24 weeks
Symptomatic Remission Psychotic Disorder, defined as:
PANSS score of 57 or less. Score range 30-210. Higher scores mean a worse outcome.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24 weeks
Psychosocial functioning, as measured by:
Functioning Assessment short test (FAST). Score range 0-72. Higher scores mean a worse outcome.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2022
- Study start23 Feb 2023
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mood DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A two-arm, parallel-group controlled, and multi-centre randomized clinical trial (RCT)
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Parnassia Groep
- Sponsor type
- University, hospital or other
- Collaborators
- Parnassia Psychiatric Institute, University of Belgrade, University of Bonn, Babes-Bolyai University, State University of New York - Upstate Medical University, Ludwig-Maximilians - University of Munich, King's College London, University of Barcelona, Maastricht University Medical Center
- Responsible party
- Sponsor
- Investigators
- Roos van Westrhenen, Professor (PhD&MD), Principal investigator, Parnassia Psychiatric Institute (Amsterdam, Parnassia Groep)Allan Young, Professor (MD&PhD), Study chair, King's College London UKMario Juruena, Professor (MD&PhD), Study chair, KIng's College London UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05656469
- Sponsor's protocol ID
- NL79649.068.21
- Other IDs
- 2023-509680-25-00, 2023
- Acronym
- PSY-PGx
- Status last verified
- May 2026
- First submitted
- 30 Nov 2022
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Intervention for Implementation of Pharmacogenetics in Psychiatry
- ClinicalTrials.gov ID
- NCT05656469
- Acronym / sponsor ID
- PSY-PGx / NL79649.068.21
- Conditions
- Mood Disorders, Anxiety Disorders, Psychotic Disorders
- Keywords
- Pharmacogenetics
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Parnassia GroepUniversity, hospital or other
- Collaborators
- Parnassia Psychiatric Institute, University of Belgrade, University of Bonn, Babes-Bolyai University, State University of New York - Upstate Medical University, Ludwig-Maximilians - University of Munich, King's College London, University of Barcelona, Maastricht University Medical Center
- Study start
- 23 Feb 2023 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 19 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- A two-arm, parallel-group controlled, and multi-centre randomized clinical trial (RCT)
| Arm | Type | Receives |
|---|---|---|
| PSY-PGx Group | Experimental | Other: Personalised medication advice based on pharmacogenetic testingThis 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. |
| Dosing as usual (DAU) group | No intervention | –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. |
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Suffer from a depressive episode (major depressive disorder and bipolar disorder (currently depressive episode)) (as assessed by the MINI International Neuropsychiatric Interview (M.I.N.I.) in agreement with Diagnostic and Statistical Manual (DSM-5 criteria) of at least moderate severity (assessed using the Structured Interview Guide for the Hamilton Depression Scale (SIGH-D) with a score of 14 or higher) and/or suffer from an anxiety disorder (panic disorder, generalised anxiety disorder) (as assessed by the M.I.N.I. in agreement with DSM-5 criteria) of at least moderate severity (assessed using the Structured Interview Guide for the Hamilton Anxiety Scale (SIGH- A) with a score of 18 or higher) and/or suffer from a psychotic disorder (schizophrenia and schizoaffective disorder) (as assessed by the M.I.N.I. in agreement with DSM-5 criteria) of at least moderate severity (assessed using the Positive and Negative Symptom Scale (PANSS) with a score of 75 or higher).
- Have had an inadequate response to at least 1 psychotropic treatment during their life-time. Inadequate response is defined as insufficient efficacy of a psychotropic treatment when dosed high enough and maintained long enough, or discontinuation of a psychotropic treatment due to AEs or intolerability.
- Are about to switch (or have switched within the last 2 weeks prior to first contact with an investigator) to sertraline or escitalopram (for patients with mood or anxiety disorders), or to aripiprazole or risperidone (for patients with psychotic disorders) due to an inadequate response to or intolerance of the current/ previous medication.
- Currently receiving inpatient or outpatient psychiatric treatment.
- Be able to understand the requirements of the study and provide written informed consent to participate in this study; a signed and dated informed consent form (ICF) will be obtained from each patient before participation in the study.
Key exclusion criteria (11 listed)
- Patients with a history of prior pharmacogenomic testing
- Patients with no prior use of psychotropic medication (medication-naïve patients)
- Severe somatic comorbidities as reported in the subject's medical history or based on clinical chemistry/electrocardiography (ECG) 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.
- Alcohol and/or substance abuse and/or dependence (except nicotine)
- Polypharmacy defined as the routine use of five or more medications including over- the-counter, prescription and/or traditional and complementary medicines used by a patient (WHO 2019).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalised medication advice based on pharmacogenetic testingPharmacogenetic genotyping provides personalised medication advice on dosage and choice of currently available and legally approved medication based on the patient's pharmacogenetic profile | Other | PSY-PGx Group |
Primary outcome
Patient recovery, as assessed using the Patient Recovery Assessment scale - Domains and Stages (RAS-DS).
Time frame: 24 weeks
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.
10 secondary outcomes
Response Mood Disorder, defined as a 50% point reduction in the following scale:
Time frame: 24 weeks
Response Anxiety Disorder, defined as a 50% point reduction in the following scale:
Time frame: 24 weeks
Response Psychotic Disorder, defined as a 50% point reduction in the following scale:
Time frame: 24 weeks
Symptomatic Remission Mood Disorder, defined as:
Time frame: 24 weeks
Symptomatic Remission Anxiety Disorder, defined as:
Time frame: 24 weeks
Symptomatic Remission Psychotic Disorder, defined as:
Time frame: 24 weeks
Burden of side effects, as measured by:
Time frame: 24 weeks
Side effects, as measured by:
Time frame: 24 weeks
General wellbeing, as measured by:
Time frame: 24 weeks
Psychosocial functioning, as measured by:
Time frame: 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Website of the PSY-PGx consortiumLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Roos van Westrhenen, Professor (PhD&MD) principal investigator
Parnassia Psychiatric Institute (Amsterdam, Parnassia Groep)
Allan Young, Professor (MD&PhD) study chair
King's College London UK
Mario Juruena, Professor (MD&PhD) study chair
KIng's College London UK
9 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalised medication advice based on pharmacogenetic testing in people with Mood Disorders and Anxiety Disorders, run by Parnassia Groep at 9 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Germany, Netherlands, United States, Romania, Serbia and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Roos van Westrhenen, Professor (MD&PhD) (+31 883583398, r.vanwestrhenen@psyq.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient recovery, as assessed using the Patient Recovery Assessment scale - Domains and Stages (RAS-DS). (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.