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

NCT ID: NCT05656469

Last Updated: 2025-07-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 2500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-23
• Study Completion Date: 2026-09-30

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

PSY-PGx Group

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.

Group Type: EXPERIMENTAL

Personalised medication advice based on pharmacogenetic testing

Intervention Type: 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

Dosing as usual (DAU) group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Personalised medication advice based on pharmacogenetic testing

Pharmacogenetic genotyping provides personalised medication advice on dosage and choice of currently available and legally approved medication based on the patient's pharmacogenetic profile

Intervention Type: OTHER

Eligibility 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 <65 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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Parnassia Psychiatric Institute

UNKNOWN

Sponsor Role: collaborator

University of Belgrade

OTHER

Sponsor Role: collaborator

University of Bonn

OTHER

Sponsor Role: collaborator

Babes-Bolyai University

OTHER

Sponsor Role: collaborator

State University of New York - Upstate Medical University

OTHER

Sponsor Role: collaborator

Ludwig-Maximilians - University of Munich

OTHER

Sponsor Role: collaborator

King's College London

OTHER

Sponsor Role: collaborator

University of Barcelona

OTHER

Sponsor Role: collaborator

Maastricht University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roos van Westrhenen, Ass. Prof.

Role: PRINCIPAL_INVESTIGATOR

Parnassia Psychiatric Institute (Amsterdam)

Roos van Westrhenen, Ass. Prof.

Role: STUDY_DIRECTOR

Parnassia Psychiatric Institute (Amsterdam)

Locations

SUNY Upstate Medical University, Department of Psychiatry and Behavioural Sciences

Syracuse, New York, United States

Site Status: NOT_YET_RECRUITING

University Hospital Bonn, Department of Psychiatry and Psychotherapy

Bonn, , Germany

Site Status: RECRUITING

Ludwig-Maximilian University, University Hospital, Institute of Psychiatric Phenomics and Genomics (IPPG)

München, , Germany

Site Status: NOT_YET_RECRUITING

Parnassia Psychiatric Institute, Department of Psychiatry

Amsterdam, , Netherlands

Site Status: RECRUITING

Maastricht University, Department of Psychiatry and Neuropsychology

Maastricht, , Netherlands

Site Status: RECRUITING

Babeş-Bolyai University, Department of Clinical Psychology and Psychotherapy

Cluj-Napoca, , Romania

Site Status: RECRUITING

University of Belgrade, Faculty of Pharmacy

Belgrade, , Serbia

Site Status: RECRUITING

Fundació Clínic per a la Recerca Biomèdica, Department of Psychiatry and Psychology, Hospital Clínic

Barcelona, , Spain

Site Status: RECRUITING

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

London, , United Kingdom

Site Status: RECRUITING

Countries

United States; Germany; Netherlands; Romania; Serbia; Spain; United Kingdom

Central Contacts

Roos van Westrhenen, Ass. Prof.

Role: CONTACT

r.vanwestrhenen@psyq.nl

+31 6 51753521

Facility Contacts

Thomas Schulze, Prof. Dr.

Role: primary

Sarah Maywald, MD

Role: primary

Urs Heilbronner, PhD

Role: primary

Roos van Westrhenen, Ass. Prof.

Role: primary

r.vanwestrhenen@psyq.nl

+31 6 51753521

Therese van Amelsvoort, Prof. Dr.

Role: primary

Ramona Moldovan, Prof.

Role: primary

Marin Jukic, Dr.

Role: primary

Natalia Elena Fares, PhD

Role: primary

Allan Young, Prof. Dr.

Role: primary

Related Links

https://www.psy-pgx.org/PSY-PGx

Website of the PSY-PGx consortium

Other Identifiers

NL79649.068.21

Identifier Type: -

Identifier Source: org_study_id