[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100489695":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":36,"locations":46,"responsibleParty":181,"collaborators":183,"id":203,"slug":204,"hasResults":205,"nctId":206,"briefTitle":207,"officialTitle":208,"acronym":209,"eligibilityCriteria":210,"healthyVolunteers":205,"sex":211,"minAge":212,"maxAge":213,"enrollmentInfo":214,"targetDuration":18,"studyType":217,"phases":218,"briefSummary":220,"conditions":221,"keywords":225,"overallStatus":67,"whyStopped":18,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":228,"startDateStruct":231,"completionDateStruct":233,"leadSponsor":235,"locationsCount":236},{"fullName":5,"class":6},"Parnassia Groep","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"PSY-PGx Group","EXPERIMENTAL","This is the intervention group. All patients will be treated according to a personalised medication recommendation based on the results of pharmacogenetic testing, following the prespecified dosing guideline. Prescribing physicians will prescribe one of the predefined drugs and will be unblinded for genotype and the resulting metabolisation phenotype.",[13],"Other: Personalised medication advice based on pharmacogenetic testing",{"label":15,"type":16,"description":17,"interventionNames":18},"Dosing as usual (DAU) group","NO_INTERVENTION","This is the control group. In this group, prescribing physicians will also prescribe one of the predefined drugs, but will remain blinded to their patients' genotype and resulting metabolism phenotype for the duration of their participation in the study. After the study, patients in the control group will also be given their pharmacogenetic profile, which will make it possible to personalise their medication if necessary.",null,[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":18},"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",[9],[25,29,33],{"name":26,"affiliation":27,"role":28},"Roos van Westrhenen, Professor (PhD&MD)","Parnassia Psychiatric Institute (Amsterdam, Parnassia Groep)","PRINCIPAL_INVESTIGATOR",{"name":30,"affiliation":31,"role":32},"Allan Young, Professor (MD&PhD)","King's College London UK","STUDY_CHAIR",{"name":34,"affiliation":35,"role":32},"Mario Juruena, Professor (MD&PhD)","KIng's College London UK",[37,42],{"name":38,"role":39,"phone":40,"phoneExt":18,"email":41},"Roos van Westrhenen, Professor (MD&PhD)","CONTACT","+31 883583398","r.vanwestrhenen@psyq.nl",{"name":43,"role":39,"phone":44,"phoneExt":18,"email":45},"Margriet Boerman, Contact person","31657940368","farmacogenetica@parnassiagroep.nl",[47,65,81,94,112,124,138,152,167],{"facility":48,"status":49,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"SUNY Upstate Medical University, Department of Psychiatry and Behavioural Sciences","NOT_YET_RECRUITING","Syracuse","New York","13210","United States","US",{"type":56,"coordinates":57},"Point",[58,59],-76.14742,43.04812,{"lat":59,"lon":58},[62,64],{"name":63,"role":39,"phone":18,"phoneExt":18,"email":18},"Thomas Schulze, Prof. Dr.",{"name":63,"role":28,"phone":18,"phoneExt":18,"email":18},{"facility":66,"status":67,"city":68,"state":18,"zip":18,"country":69,"countryCode":70,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"University Hospital Bonn, Department of Psychiatry and Psychotherapy","RECRUITING","Bonn","Germany","DE",{"type":56,"coordinates":72},[73,74],7.09549,50.73438,{"lat":74,"lon":73},[77,79],{"name":78,"role":39,"phone":18,"phoneExt":18,"email":18},"Sarah Maywald, MD",{"name":80,"role":28,"phone":18,"phoneExt":18,"email":18},"Alexandra Philipsen, Prof. Dr.",{"facility":82,"status":67,"city":83,"state":18,"zip":18,"country":69,"countryCode":70,"cosmosGeoPoint":84,"geoPoint":88,"contacts":89},"Ludwig-Maximilian University, University Hospital, Institute of Psychiatric Phenomics and Genomics (IPPG)","München",{"type":56,"coordinates":85},[86,87],13.31243,51.60698,{"lat":87,"lon":86},[90,92],{"name":91,"role":39,"phone":18,"phoneExt":18,"email":18},"Urs Heilbronner, PhD",{"name":93,"role":28,"phone":18,"phoneExt":18,"email":18},"Urs Heilbronner, Dr.",{"facility":95,"status":67,"city":96,"state":18,"zip":18,"country":97,"countryCode":98,"cosmosGeoPoint":99,"geoPoint":103,"contacts":104},"Parnassia Psychiatric Institute, Department of Psychiatry","Amsterdam","Netherlands","NL",{"type":56,"coordinates":100},[101,102],4.88969,52.37403,{"lat":102,"lon":101},[105,108,111],{"name":106,"role":39,"phone":107,"phoneExt":18,"email":41},"Roos van Westrhenen, Prof.","+31 88-358339",{"name":109,"role":39,"phone":110,"phoneExt":18,"email":45},"Margriet Boerman, Contact Persob","+31-657940368",{"name":106,"role":28,"phone":18,"phoneExt":18,"email":18},{"facility":113,"status":67,"city":114,"state":18,"zip":18,"country":97,"countryCode":98,"cosmosGeoPoint":115,"geoPoint":119,"contacts":120},"Maastricht University, Department of Psychiatry and Neuropsychology","Maastricht",{"type":56,"coordinates":116},[117,118],5.68889,50.84833,{"lat":118,"lon":117},[121,123],{"name":122,"role":39,"phone":18,"phoneExt":18,"email":18},"Therese van Amelsvoort, Prof. Dr.",{"name":122,"role":28,"phone":18,"phoneExt":18,"email":18},{"facility":125,"status":67,"city":126,"state":18,"zip":18,"country":127,"countryCode":128,"cosmosGeoPoint":129,"geoPoint":133,"contacts":134},"Babeş-Bolyai University, Department of Clinical Psychology and Psychotherapy","Cluj-Napoca","Romania","RO",{"type":56,"coordinates":130},[131,132],23.6,46.76667,{"lat":132,"lon":131},[135,137],{"name":136,"role":39,"phone":18,"phoneExt":18,"email":18},"Ramona Moldovan, Prof.",{"name":136,"role":28,"phone":18,"phoneExt":18,"email":18},{"facility":139,"status":67,"city":140,"state":18,"zip":18,"country":141,"countryCode":142,"cosmosGeoPoint":143,"geoPoint":147,"contacts":148},"University of Belgrade, Faculty of Pharmacy","Belgrade","Serbia","RS",{"type":56,"coordinates":144},[145,146],20.46513,44.80401,{"lat":146,"lon":145},[149,151],{"name":150,"role":39,"phone":18,"phoneExt":18,"email":18},"Marin Jukic, Dr.",{"name":150,"role":28,"phone":18,"phoneExt":18,"email":18},{"facility":153,"status":67,"city":154,"state":18,"zip":18,"country":155,"countryCode":156,"cosmosGeoPoint":157,"geoPoint":161,"contacts":162},"Fundació Clínic per a la Recerca Biomèdica, Department of Psychiatry and Psychology, Hospital Clínic","Barcelona","Spain","ES",{"type":56,"coordinates":158},[159,160],2.15899,41.38879,{"lat":160,"lon":159},[163,165],{"name":164,"role":39,"phone":18,"phoneExt":18,"email":18},"Natalia Elena Fares, PhD",{"name":166,"role":28,"phone":18,"phoneExt":18,"email":18},"Eduard Vieta, Prof. Dr.",{"facility":168,"status":67,"city":169,"state":18,"zip":18,"country":170,"countryCode":171,"cosmosGeoPoint":172,"geoPoint":176,"contacts":177},"King's College, Institute of Psychiatry, Psychology & Neuroscience","London","United Kingdom","UK",{"type":56,"coordinates":173},[174,175],-0.12574,51.50853,{"lat":175,"lon":174},[178,180],{"name":179,"role":39,"phone":18,"phoneExt":18,"email":18},"Allan Young, Prof. Dr.",{"name":179,"role":28,"phone":18,"phoneExt":18,"email":18},{"type":182,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[184,187,189,191,193,195,197,199,201],{"name":185,"class":186},"Parnassia Psychiatric Institute","UNKNOWN",{"name":188,"class":6},"University of Belgrade",{"name":190,"class":6},"University of Bonn",{"name":192,"class":6},"Babes-Bolyai University",{"name":194,"class":6},"State University of New York - Upstate Medical University",{"name":196,"class":6},"Ludwig-Maximilians - University of Munich",{"name":198,"class":6},"King's College London",{"name":200,"class":6},"University of Barcelona",{"name":202,"class":6},"Maastricht University Medical Center","100489695","clinical-study-evaluating-pharmacogenomics-informed-pharmacotherapy-versus-dosing-as-usual-in-psychiatric-disorders-100489695",false,"NCT05656469","Clinical Study Evaluating Pharmacogenomics-informed Pharmacotherapy Versus Dosing as Usual in Psychiatric Disorders","A New Intervention for Implementation of Pharmacogenetics in Psychiatry","PSY-PGx","Inclusion Criteria:\n\n1. 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\u002For 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\u002For 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).\n2. 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.\n3. 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\u002F previous medication.\n4. Currently receiving inpatient or outpatient psychiatric treatment.\n5. 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.\n6. To give written consent to the use and disclosure of clinical data from their medical records for the purpose of this study.\n7. Age between ≥16 and \\\u003C70 years.\n8. Ownership of a mobile phone (Android or iOS operation system) for passive monitoring.\n\nExclusion Criteria:\n\n1. Patients with a history of prior pharmacogenomic testing\n2. Patients with no prior use of psychotropic medication (medication-naïve patients)\n3. Severe somatic comorbidities as reported in the subject's medical history or based on clinical chemistry\u002Felectrocardiography (ECG) results up to six months ago. If any of these comorbidities is detected on the basis of physical examination and\u002For clinical chemistry and\u002For ECG at the screening visit, participation is not possible.\n\n   * Liver disease defined as follows: Alanine-Aminotransferase (ALAT) \\>70u\u002FL\n   * Renal disease: Estimated glomerular filtration rate (eGFR) \\\u003C 60ml\u002Fmin\u002F1.73m2\n   * Diabetes: Blood glucose \\> 11.1 mmol\u002FL or twice a fasting glucose \\> 7.0 mmol\u002FL\n   * Cardiac disease: prolonged QT-interval.\n4. Alcohol and\u002For substance abuse and\u002For dependence (except nicotine)\n5. Polypharmacy defined as the routine use of five or more medications including over- the-counter, prescription and\u002For traditional and complementary medicines used by a patient (WHO 2019).\n6. Inability to use the mobile phone application\n7. Pregnant or breastfeeding women","ALL","16 Years","70 Years",{"count":215,"type":216},2500,"ESTIMATED","INTERVENTIONAL",[219],"NA","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.",[222,223,224],"Mood Disorders","Anxiety Disorders","Psychotic Disorders",[226],"Pharmacogenetics","2026-05-29",{"date":229,"type":230},"2026-06-02","ACTUAL",{"date":232,"type":230},"2023-02-23",{"date":234,"type":216},"2026-09",{"name":5,"class":6},9]