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Clinical Study Evaluating Pharmacogenomics-informed Pharmacotherapy Versus Dosing as Usual in Psychiatric Disorders

Sponsor: Parnassia Groep

NCT ID: NCT05656469

View on ClinicalTrials.gov ↗

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.

Mood DisordersAnxiety DisordersPsychotic Disorders

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

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

the Positiveand NegativeeGFR

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
Inclusion Criteria: 1. 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). 2. 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. 3. 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. 4. Currently receiving inpatient or outpatient psychiatric treatment. 5. 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. 6. To give written consent to the use and disclosure of clinical data from their medical records for the purpose of this study. 7. Age between ≥16 and \<70 years. 8. Ownership of a mobile phone (Android or iOS operation system) for passive monitoring. Exclusion Criteria: 1. Patients with a history of prior pharmacogenomic testing 2. Patients with no prior use of psychotropic medication (medication-naïve patients) 3. 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 * Cardiac disease: prolonged QT-interval. 4. Alcohol and/or substance abuse and/or dependence (except nicotine) 5. 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). 6. Inability to use the mobile phone application 7. Pregnant or breastfeeding women

Where Is This Study? (1 UK site)

King's College, Institute of Psychiatry, Psychology & Neuroscience

London, United Kingdom

Recruiting
Site contact (verified)
Allan Young, Prof. Dr.Principal Investigator

How to Get in Touch

Roos van Westrhenen, Professor (MD&PhD)

Sponsor contact

CONTACT

+31 883583398 r.vanwestrhenen@psyq.nl

Margriet Boerman, Contact person

Sponsor contact

CONTACT

31657940368 farmacogenetica@parnassiagroep.nl
Data sourced from ClinicalTrials.gov · Last verified: 2026-05