RecruitingNot ApplicableNCT05656469

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

A New Intervention for Implementation of Pharmacogenetics in Psychiatry

Sponsor

Maastricht University Medical Center

Enrollment

2,500 participants

Start Date

Feb 23, 2023

Study Type

INTERVENTIONAL

Conditions

Psychotic Disorders Anxiety Disorders Mood Disorders

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

Min Age: 16 YearsMax Age: 65 Years

Inclusion Criteria8

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 \<65 years.
Ownership of a mobile phone (Android or iOS operation system) for passive monitoring.

Exclusion Criteria11

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

Interventions

OTHERPersonalised 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