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

NCT05656469 | Recruiting DMC

• 2 other identifiers: NL79649.068.212023-509680-25-00
• Study Type: interventional
• Target: 2,500
• Locations: 7 countries
• Sites: 9

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.

Conditions

Mood Disorders; Anxiety Disorders; Psychotic Disorders

Keywords

Pharmacogenetics

Outcome Measures

Primary Outcomes (1)

• 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.

  24 weeks

Secondary Outcomes (10)

• Response Mood Disorder, defined as a 50% point reduction in the following scale:

  24 weeks

• Response Anxiety Disorder, defined as a 50% point reduction in the following scale:

  24 weeks

• Response Psychotic Disorder, defined as a 50% point reduction in the following scale:

  24 weeks

• Symptomatic Remission Mood Disorder, defined as:

  24 weeks

• Symptomatic Remission Anxiety Disorder, defined as:

  24 weeks

Other Outcomes (1)

• Passive behavioral monitoring using the BeHAPP mobile application.

  24 weeks

Study Arms (2)

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.

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.

Interventions

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

PSY-PGx Group

Eligibility Criteria

• Age: 16 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Parnassia Psychiatric Institute: collaborator
• Parnassia Groep: lead
• Ludwig-Maximilians - University of Munich: collaborator
• University of Barcelona: collaborator
• University of Belgrade: collaborator
• King's College London: collaborator
• Maastricht University Medical Center: collaborator
• University of Bonn: collaborator
• Babes-Bolyai University: collaborator
• State University of New York - Upstate Medical University: collaborator

Study Sites (9)

SUNY Upstate Medical University, Department of Psychiatry and Behavioural Sciences

Syracuse, New York, 13210, United States

NOT YET RECRUITING

University Hospital Bonn, Department of Psychiatry and Psychotherapy

Bonn, Germany

RECRUITING

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

München, Germany

RECRUITING

Parnassia Psychiatric Institute, Department of Psychiatry

Amsterdam, Netherlands

RECRUITING

Maastricht University, Department of Psychiatry and Neuropsychology

Maastricht, Netherlands

RECRUITING

Babeş-Bolyai University, Department of Clinical Psychology and Psychotherapy

Cluj-Napoca, Romania

RECRUITING

University of Belgrade, Faculty of Pharmacy

Belgrade, Serbia

RECRUITING

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

Barcelona, Spain

RECRUITING

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

London, United Kingdom

RECRUITING

Related Links

• Website of the PSY-PGx consortium

MeSH Terms

Conditions

Mood Disorders; Anxiety Disorders; Psychotic Disorders

Condition Hierarchy (Ancestors)

Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders

Study Officials

• Roos van Westrhenen, Professor (PhD&MD)

  Parnassia Psychiatric Institute (Amsterdam, Parnassia Groep)

  PRINCIPAL INVESTIGATOR

• Allan Young, Professor (MD&PhD)

  King's College London UK

  STUDY CHAIR

• Mario Juruena, Professor (MD&PhD)

  KIng's College London UK

  STUDY CHAIR

Central Study Contacts

Roos van Westrhenen, Professor (MD&PhD)

CONTACT

+31 883583398; r.vanwestrhenen@psyq.nl

Margriet Boerman, Contact person

CONTACT

31657940368; farmacogenetica@parnassiagroep.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patient- and rater-blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A two-arm, parallel-group controlled, and multi-centre randomized clinical trial (RCT)

Study Record Dates

• First Submitted: November 30, 2022
• First Posted: December 19, 2022
• Study Start: February 23, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: June 2, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); GB (1); NL (2); RO (1); SE (1); ES (1); DE (2)