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

Inclusion Criteria:

1. Suffer from a depressive episode (major depressive disorder and bipolar disorder (currently depressive episode)) (as assessed by the MINI InternationalNeuropsychiatric Interview (M.I.N.I.) in agreement with Diagnostic and StatisticalManual (DSM-5 criteria) of at least moderate severity (assessed using the StructuredInterview Guide for the Hamilton Depression Scale (SIGH-D) with a score of 14 orhigher) and/or suffer from an anxiety disorder (panic disorder, generalised anxietydisorder) (as assessed by the M.I.N.I. in agreement with DSM-5 criteria) of at leastmoderate severity (assessed using the Structured Interview Guide for the HamiltonAnxiety Scale (SIGH- A) with a score of 18 or higher) and/or suffer from a psychoticdisorder (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 thePositive 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 theirlife-time. Inadequate response is defined as insufficient efficacy of a psychotropictreatment when dosed high enough and maintained long enough, or discontinuation of apsychotropic treatment due to AEs or intolerability.

3. Are about to switch (or have switched within the last 2 weeks prior to first contactwith an investigator) to sertraline or escitalopram (for patients with mood oranxiety disorders), or to aripiprazole or risperidone (for patients with psychoticdisorders) due to an inadequate response to or intolerance of the current/ previousmedication.

4. Currently receiving inpatient or outpatient psychiatric treatment.

5. Be able to understand the requirements of the study and provide written informedconsent 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 theirmedical 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 passivemonitoring.

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 basedon clinical chemistry/electrocardiography (ECG) results up to six months ago. If anyof these comorbidities is detected on the basis of physical examination and/orclinical 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 apatient (WHO 2019).

6. Inability to use the mobile phone application

7. Pregnant or breastfeeding women