A New Intervention for Implementation of Pharmacogenetics in Psychiatry

Start 3 Jun 2025 · Status Ongoing, recruiting · 3 EU/EEA countries · 4 sites · Protocol NL79649.068.21

Overview

Sponsor-declared trial summary

Phase Therapeutic use (Phase IV)

Status Ongoing, recruiting

Participants planned 1,470

Countries 3

Sites 4

Mood disorder (major depressive disorder and bipolar disorder (currently depressive episode)) Anxiety disorder (panic disorder, social phobia, specific phobia, agoraphobia, generalised anxiety disorder) Psychotic disorder (schizophrenia and schizoaffective disorder)

Compare individualised medication dosing based on pharmacogenetics in psychiatric patients with dosing as usual

Key facts

Sponsor: Parnassia Groep B.V.
Participant type: Patients
Age range: 18-64 years
Gender: Male and Female
Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
Trial duration: 3 Jun 2025 → ongoing
Decision date (initial): 2024-11-12
Transition trial: No
Low-intervention: Yes
Rare-disease indication: No
Vulnerable population: Yes
Funding sources: European Union’s Horizon 2020 research and innovation program under grant agreement No 945151

External identifiers

EU CT number: 2023-509680-25-00
ClinicalTrials.gov: NCT05656469

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy, Pharmacogenetic

Compare individualised medication dosing based on pharmacogenetics in psychiatric patients with dosing as usual

Secondary objectives 3

Evaluation of the impact of pharmacogenetic testing on clinical response, side effects, general wellbeing, and psychosocial functioning.
Deep phenotyping of patients during the clinical trial to identify other factors besides pharmacogenetics that may influence individual medication response, including passive monitoring of behavioural aspects by means of a mobile phone application.
Investigate other genetic factors related to medication response including genetic variants related to drug absorption, distribution, metabolism and elimination.

Conditions and MedDRA coding

Version	Level	Code	Term	System organ class
20.0	PT	10057666	Anxiety disorder	100000004873
20.1	LLT	10079614	Mood disorder	10037175
20.0	PT	10061920	Psychotic disorder	100000004873

Study design 1 period

#	Title	Allocation	Blinding	Roles blinded	Arms
1	Allocation of patients After inclusion, all participants will be randomly assigned (eCRF) to one of the study branches, stratified by diagnosis	Randomised Controlled	Double	[{"id":157313,"code":2,"name":"Investigator"},{"id":157314,"code":1,"name":"Subject"}]	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 Dosing as usual (DAU) group: This is the control group. In this group, prescribing physicians will also prescribe one of the predefined drugs according to treatments guides.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

Suffer from a depressive episode (major depressive disorder and bipolar disorder (currently depressive episode)) (as assessed by the MINI in agreement with 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 (for example panic disorder, social phobia, specific phobia, agoraphobia, generalised anxiety disorder) (as assessed by the MINI 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 MINI 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 any procedure of 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 ≥18and <65 years
Women of child-bearing potential must have a negative pregnancy test in serum/urine before the inclusion in the study and agree to use highly effective contraceptive methods during the study. Highly effective contraceptive methods will include: intrauterine device, bilateral tubal occlusion,vasectomized partner and sexual abstinence. Hormonal contraceptive methods is accepted because there are no additional risk for this trial.

Exclusion criteria 6

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 defined as: Estimated glomerular filtratrion rate (eGFR) < 60mL/min/1.73m2; Uncontrolled diabetes considering screening blood tests (Blood glucose > 11.1 mmol/L or two timestwice fasting glucose > 7.0 mmol/L); Cardiac disease defined as: prolonged QT-interval
Alcohol and/or substance abuse and/or dependence (except nicotine) , allowing mild substance/ alcohol use disorder (as assessed by the MINI in agreement with DSM-5 criteria).
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) , excluding the study medication.
Pregnant or breastfeeding women

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

Patient recovery at 24 weeks, as assessed using the patient recovery assessment scale (RAS, RAS-DS))

Secondary endpoints 1

Well-being and quality of life (EuroQol 5 Dimensions-5 levels questionnaire; EQ-5D-5L). Psychosocial functioning (Functioning Assessment Short Test (FAST)). Clinical symptomatology (SIGH-D; for patients with mood disorders), (SIGH-A; anxiety disorders), and the PANSS (for psychotic patients). Side effects (Frequency, Intensity and Burden of side effects ratings (FIBSER) and the Udvalg for Kliniske Undersogelse – Side Effects Rating Scale (UKU-SERS)). Obtained over a 24-week period

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 4

Risperidone

SUB10335MIG · Substance

Active substance: Risperidone
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL
Max daily dose: 6 mg milligram(s)
Max total dose: 1 g gram(s)
Max treatment duration: 24 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Sertraline

SUB10499MIG · Substance

Active substance: Sertraline
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL
Max daily dose: 150 mg milligram(s)
Max total dose: 25.2 g gram(s)
Max treatment duration: 24 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Escitalopram

SUB16425MIG · Substance

Active substance: Escitalopram
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL
Max daily dose: 20 mg milligram(s)
Max total dose: 3.36 g gram(s)
Max treatment duration: 24 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Aripiprazole

SUB05564MIG · Substance

Active substance: Aripiprazole
Pharmaceutical form: TABLETS
Route of administration: ORAL
Max daily dose: 30 mg milligram(s)
Max total dose: 5.04 g gram(s)
Max treatment duration: 24 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Parnassia Groep B.V.

Sponsor organisation: Parnassia Groep B.V.
Address: Monsterseweg 93
City: 's-Gravenhage
Postcode: 2553 RJ
Country: Netherlands

Scientific contact point

Organisation: Parnassia Groep B.V.
Contact name: Prof. R. van Westrhenen

Public contact point

Organisation: Parnassia Groep B.V.
Contact name: Prof. R. van Westrhenen

Locations

3 EU/EEA countries · 4 investigational sites

By country

Country	MS status	Planned subjects	Sites
Germany	Ongoing, recruiting	610	2
Netherlands	Ongoing, recruiting	650	1
Spain	Ongoing, recruiting	210	1
Rest of world	—	0	—

Investigational sites

Germany

2 sites · Ongoing, recruiting

Ludwig Maximilian University Of Munich

Psychiatry, Nussbaumstrasse 7, Ludwigsvorstadt-Isarvorstadt, Munich

Universitaetsklinikum Bonn AöR

Psychiatry, Venusberg-Campus 1, Venusberg, Bonn

Netherlands

1 site · Ongoing, recruiting

Parassia Groep B.V.

Psychiatry, Overschiestraat 57, 1062 HN, Amsterdam

Spain