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.
Effective pharmacotherapeutic treatments for mental disorders are available, but their effectiveness is limited by low compliance due to frequent side effects. This is partly due to patient heterogeneity in the genes encoding for drug-metabolising enzymes. Pharmacogenetic testing allows the assessment of person-specific genetic factors that are thought to predict clinical response and side effects. Recent studies have suggested that genotyping genes encoding drug-metabolizing enzymes may improve treatment efficacy and tolerability, potentially benefitting millions of patients. PSY-PGx is the first initiative to propose a large-scale non-industry sponsored clinical study that aims to demonstrate the clinical benefits and potential of the implementation of pharmacogenetics for psychiatric patients in existing medical settings. This is an international 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
2,500
Pharmacogenetic genotyping provides personalised medication advice on dosage and choice of currently available and legally approved medication based on the patient's pharmacogenetic profile
SUNY Upstate Medical University, Department of Psychiatry and Behavioural Sciences
Syracuse, New York, United States
NOT_YET_RECRUITINGUniversity Hospital Bonn, Department of Psychiatry and Psychotherapy
Bonn, Germany
RECRUITINGPatient recovery, as assessed using the Patient Recovery Assessment scale - Domains and Stages (RAS-DS).
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.
Time frame: 24 weeks
Response Mood Disorder, defined as a 50% point reduction in the following scale:
Structured interview Guide for the Hamilton Depression Scale (SIGH-D) for depressive disorder. Score range 0-52. Higher scores mean a worse outcome.
Time frame: 24 weeks
Response Anxiety Disorder, defined as a 50% point reduction in the following scale:
Structured interview Guide for the Hamilton Anxiety Scale (SIGH-A) for anxiety disorder. Score range 0-56. Higher scores mean a worse outcome.
Time frame: 24 weeks
Response Psychotic Disorder, defined as a 50% point reduction in the following scale:
Positive and Negative Symptom Scale (PANSS) for psychotic disorder. Score range 30-210. Higher scores mean a worse outcome.
Time frame: 24 weeks
Symptomatic Remission Mood Disorder, defined as:
SIGH-D score of 7 or less. Score range 0-52. Higher scores mean a worse outcome.
Time frame: 24 weeks
Symptomatic Remission Anxiety Disorder, defined as:
SIGH-A score of 7 or less. Score range 0-56. Higher scores mean a worse outcome.
Time frame: 24 weeks
Symptomatic Remission Psychotic Disorder, defined as:
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Ludwig-Maximilian University, University Hospital, Institute of Psychiatric Phenomics and Genomics (IPPG)
München, Germany
RECRUITINGParnassia Psychiatric Institute, Department of Psychiatry
Amsterdam, Netherlands
RECRUITINGMaastricht University, Department of Psychiatry and Neuropsychology
Maastricht, Netherlands
RECRUITINGBabeş-Bolyai University, Department of Clinical Psychology and Psychotherapy
Cluj-Napoca, Romania
RECRUITINGUniversity of Belgrade, Faculty of Pharmacy
Belgrade, Serbia
RECRUITINGFundació Clínic per a la Recerca Biomèdica, Department of Psychiatry and Psychology, Hospital Clínic
Barcelona, Spain
RECRUITINGKing's College, Institute of Psychiatry, Psychology & Neuroscience
London, United Kingdom
RECRUITINGPANSS score of 57 or less. Score range 30-210. Higher scores mean a worse outcome.
Time frame: 24 weeks
Burden of side effects, as measured by:
Frequency, Intensity and Burden of side effects ratings (FIBSER). Score range 0-18. Higher scores mean a worse outcome.
Time frame: 24 weeks
Side effects, as measured by:
Udvalg for Kliniske Undersogelse - Side Effects Rating Scale (UKU-SERS). Score range 0-135. Higher scores mean a worse outcome.
Time frame: 24 weeks
General wellbeing, as measured by:
The 5-level EQ-5D version (EQ-5D-5L). Score range 5-25. Higher scores mean a worse outcome. Visual Analog Scale (VAS)-score 0-100. A higher score means a better outcome.
Time frame: 24 weeks
Psychosocial functioning, as measured by:
Functioning Assessment short test (FAST). Score range 0-72. Higher scores mean a worse outcome.
Time frame: 24 weeks