Clinical Study Evaluating Pharmacogenomics-informed Pharmacotherapy Versus Dosing as Usual in Psychiatric Disorders
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16-70
SponsorParnassia Groep
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Patients with a history of prior pharmacogenomic testing
Patients with no prior use of psychotropic medication (medication-naïve patients)
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
Trial design
Design model
Parallel
Treatments tested in this trial
Personalised medication advice based on pharmacogenetic testing
Other interventionPharmacogenetic genotyping provides personalised medication advice on dosage and choice of currently available and legally approved medication based on the patient's pharmacogenetic profile
Treatment groups
2,500 Participants
are divided into 2 treatment groupsGroup A: PSY-PGx GroupExperimental treatment 1 intervention
Group B: Dosing as usual (DAU) groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Patient 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 weeksSecondary outcomes
1
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 weeks2
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 weeks3
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 weeks4
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 weeksOther outcomes
1
Passive behavioral monitoring using the BeHAPP mobile application.
The BEHAPP mobile application will be used to collect passive, social behavioural data as additional outcome measure that has been shown to be of value in predicting relapse/recurrence. Once the application is installed and initialised, it passively collects (meta)data on phone call activity, Bluetooth devices and WiFi access points in the participant's immediate environment, location updates and mobile application usage.
Time frame
24 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Parnassia Groep
Lead sponsor
Parnassia Psychiatric Institute
Collaborator
University of Belgrade
Collaborator
University of Bonn
Collaborator
Babes-Bolyai University
Collaborator
State University of New York - Upstate Medical University
Collaborator
Ludwig-Maximilians - University of Munich
Collaborator
King's College London
Collaborator
University of Barcelona
Collaborator
Maastricht University Medical Center
Collaborator
Source ClinicalTrials.gov