Actively Recruiting
Clinical Study Evaluating Pharmacogenomics-informed Pharmacotherapy Versus Dosing as Usual in Psychiatric Disorders
Led by Parnassia Groep · Updated on 2026-06-02
2500
Participants Needed
9
Research Sites
N/A
Total Duration
On this page
Sponsors
P
Parnassia Groep
Lead Sponsor
P
Parnassia Psychiatric Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the benefits of pharmacogenetics-informed pharmacotherapy compared to usual dosing in psychiatric patients with mood, anxiety, or psychotic disorders. This international clinical trial aims to determine if using genetic testing to guide medication choices and dosages can improve treatment outcomes and reduce side effects. The study includes a 24-week randomized, controlled design with patient and rater blinding to assess these effects in real-world medical settings. Participants are assigned to one of two groups: the intervention group receives personalized medication recommendations based on pharmacogenetic testing results, while the control group receives standard dosing without genetic information. Prescribing physicians in the intervention group are unblinded to genetic profiles to guide treatment, whereas those in the control group remain blinded until study completion. All patients will receive one of several predefined medications suitable for their diagnosis. During the 24 weeks, participants will be regularly assessed for recovery using the Patient Recovery Assessment scale and other measures including symptom response, remission, side effect burden, general wellbeing, and psychosocial functioning. Data on patient recovery and side effects will be collected to evaluate the clinical benefits of pharmacogenetics-guided therapy. The study involves inpatient and outpatient psychiatric treatment settings and requires participants to use a mobile phone application for passive monitoring throughout the trial.
CONDITIONS
Brief Title
Clinical Study Evaluating Pharmacogenomics-informed Pharmacotherapy Versus Dosing as Usual in Psychiatric Disorders
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have a depressive episode, anxiety disorder, or psychotic disorder of at least moderate severity confirmed by specific clinical interviews and rating scales
- Have had an inadequate response to at least one psychotropic treatment during their lifetime
- Are about to switch or have recently switched to sertraline, escitalopram, aripiprazole, or risperidone due to prior inadequate response or intolerance
- Currently receiving inpatient or outpatient psychiatric treatment
- Able to understand study requirements and provide written informed consent
- Agree to the use and disclosure of clinical data for this study
- Aged 16 to under 70 years
- Own a mobile phone with Android or iOS operating system for passive monitoring
You will not qualify if you...
- Prior pharmacogenomic testing
- No prior use of psychotropic medication (medication-naive patients)
- Severe somatic comorbidities such as liver disease, renal disease, diabetes, or cardiac disease based on recent medical history or tests
- Alcohol or substance abuse or dependence (except nicotine)
- Routine use of five or more medications including over-the-counter and complementary medicines
- Inability to use the mobile phone application
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 weeks
Participants receive pharmacotherapy based on either pharmacogenomics-informed personalized medication advice or dosing as usual for psychiatric disorders.
Regular visits during the 24-week treatment period
Trial Site Locations
Total: 9 locations
1
SUNY Upstate Medical University, Department of Psychiatry and Behavioural Sciences
Syracuse, New York, United States, 13210
Not Yet Recruiting
2
University Hospital Bonn, Department of Psychiatry and Psychotherapy
Bonn, Germany
Actively Recruiting
3
Ludwig-Maximilian University, University Hospital, Institute of Psychiatric Phenomics and Genomics (IPPG)
München, Germany
Actively Recruiting
4
Parnassia Psychiatric Institute, Department of Psychiatry
Amsterdam, Netherlands
Actively Recruiting
5
Maastricht University, Department of Psychiatry and Neuropsychology
Maastricht, Netherlands
Actively Recruiting
6
Babeş-Bolyai University, Department of Clinical Psychology and Psychotherapy
Cluj-Napoca, Romania
Actively Recruiting
7
University of Belgrade, Faculty of Pharmacy
Belgrade, Serbia
Actively Recruiting
8
Fundació Clínic per a la Recerca Biomèdica, Department of Psychiatry and Psychology, Hospital Clínic
Barcelona, Spain
Actively Recruiting
9
King's College, Institute of Psychiatry, Psychology & Neuroscience
London, United Kingdom
Actively Recruiting
Research Team
R
Roos van Westrhenen, Professor (MD&PhD)
M
Margriet Boerman, Contact person
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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