NCT05656469 Clinical Study Evaluating Pharmacogenomics-informed Pharmacotherapy Versus Dosing as Usual in Psychiatric Disorders
| NCT ID | NCT05656469 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Parnassia Groep |
| Condition | Mood Disorders |
| Study Type | INTERVENTIONAL |
| Enrollment | 2,500 participants |
| Start Date | 2023-02-23 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 2,500 participants in total. It began in 2023-02-23 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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 \<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
Contact & Investigator
Roos van Westrhenen, Professor (PhD&MD)
PRINCIPAL INVESTIGATOR
Parnassia Psychiatric Institute (Amsterdam, Parnassia Groep)
Frequently Asked Questions
Who can join the NCT05656469 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, up to 70 Years, studying Mood Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05656469 currently recruiting?
Yes, NCT05656469 is actively recruiting participants. Contact the research team at r.vanwestrhenen@psyq.nl for enrollment information.
Where is the NCT05656469 trial being conducted?
This trial is being conducted at Syracuse, United States, Bonn, Germany, München, Germany, Amsterdam, Netherlands and 5 additional locations.
Who is sponsoring the NCT05656469 clinical trial?
NCT05656469 is sponsored by Parnassia Groep. The principal investigator is Roos van Westrhenen, Professor (PhD&MD) at Parnassia Psychiatric Institute (Amsterdam, Parnassia Groep). The trial plans to enroll 2,500 participants.