Tests genetic-guided medicine advice for mood, anxiety or psychotic disorders
Compares medicine choices guided by genetic testing with usual dosing in psychiatric patients.
Plain-language title generated from the registry record
Registry title: Clinical Study Evaluating Pharmacogenomics-informed Pharmacotherapy Versus Dosing as Usual in Psychiatric Disorders
Key facts
- Where
- Syracuse, United StatesSee the site
- Phase
- Phase 4
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 16 and 70 years old?
Source: NCT05656469, who can take part
Where in United States
- SUNY Upstate Medical University, Department of Psychiatry and Behavioural SciencesSyracuse, United StatesNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Parnassia Groep
- Trial code
- NCT05656469EU 2023-509680-25-00
- Record updated
- 2 June 2026
- Original description
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.Read full original descriptionShow less
A New Intervention for Implementation of Pharmacogenetics in Psychiatry
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.
Inclusion: 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 <70 years; Ownership of a mobile phone (Android or iOS operation system) for passive monitoring.
Exclusion: Patients with a history of prior pharmacogenomic testing; Patients with no prior use of psychotropic medication (medication-naïve patients); 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); 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); Inability to use the mobile phone application; Pregnant or breastfeeding women.