Personalised medication advice based on pharmacogenetic testing
Personalised 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
Study 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
Sex
ALL
Min age
16 Years
Max age
70 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Patient recovery, as assessed using the Patient Recovery Assessment scale - Domains and Stages (RAS-DS). — 24 weeks A standardised self-report tool that measures mental health recovery as defined by the client. Repeated use of the instrument makes it possible to detect change over time.
Score range 38-152. Higher scores mean a better outcome.
Trial sites (9)
Facility
City
Region
Status
SUNY Upstate Medical University, Department of Psychiatry and Behavioural Sciences
Syracuse
New York
Not Yet Recruiting
University Hospital Bonn, Department of Psychiatry and Psychotherapy
Bonn
Germany
Recruiting
Ludwig-Maximilian University, University Hospital, Institute of Psychiatric Phenomics and Genomics (IPPG)
München
Germany
Recruiting
Parnassia Psychiatric Institute, Department of Psychiatry
Amsterdam
Netherlands
Recruiting
Maastricht University, Department of Psychiatry and Neuropsychology
Maastricht
Netherlands
Recruiting
Babeş-Bolyai University, Department of Clinical Psychology and Psychotherapy
Cluj-Napoca
Romania
Recruiting
University of Belgrade, Faculty of Pharmacy
Belgrade
Serbia
Recruiting
Fundació Clínic per a la Recerca Biomèdica, Department of Psychiatry and Psychology, Hospital Clínic
Barcelona
Spain
Recruiting
King's College, Institute of Psychiatry, Psychology & Neuroscience
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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