mood, anxiety and psychotic disorders mood, anxiety and psychotic disorders
Conditions
Interventions
Patients will be randomized into two groups per disorder (mood, anxiety, or 
psychotic disorder). In the pharmacogenetics testing group, patients will 
receive personalised medication advice on dosage and choice of currently 
available and legally approved medication based on patients pharmacogenetic 
profile. In the control group, patients will be prescribed medication from the 
same group of commonly used drugs, but according to the usual routines in 
clinical practice without the help of pharmacogenetic testing.
Sponsors
Universiteit Maastricht
Eligibility
Age
16 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. 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 (panic disorder, 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). 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
Exclusion criteria
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 filtratrion rate (eGFR) < 60mL/min/1.73m2 - Diabetes: Blood glucose > 11.1 mmol/L or two timestwice fasting glucose > 7.0 mmol/L - Cardiac disease: QT interval prolongation 4. Alcohol and/or substance abuse and/or dependence (except nicotine) 5. Polypharmacy defined as the routine use of five or more psychotropic 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome will be clinical recovery as measured by the Recovery Assessment Scale (RAS-DS). | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical response rates, remission rates, functional outcomes, as well as overall patient well-being and level of side effects will be considered as secondary outcomes. Passive behavioural activity data will be also collected using the BeHAPP mobile application. | — |
Countries
Germany, Netherlands, Romania, Serbia, Spain, United Kingdom, United States
Contacts
Public ContactKRJ Schruers
Universiteit Maastricht
Outcome results
None listed