Evaluating personalized medication based on genetic testing for psychiatric disorders

A New Intervention for Implementation of Pharmacogenetics in Psychiatry

This study is testing if giving personalized medication advice based on your genes can help people with mood, anxiety, or psychotic disorders feel better compared to regular medication dosing.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 2500 (estimated)
• Ages: 16 Years to 65 Years
• Sex: All
• Sponsor: Maastricht University Medical Center (Academic / other)
• Locations: 9 sites (Syracuse, New York and 8 other locations)
• Trial ID: NCT05656469 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of pharmacogenetics-informed pharmacotherapy compared to standard dosing in patients with mood, anxiety, or psychotic disorders. Over 24 weeks, participants will receive personalized medication advice based on their genetic profiles, which may predict their response to treatment and side effects. The study is designed to be patient- and rater-blinded, ensuring unbiased results. It aims to demonstrate the clinical benefits of integrating pharmacogenetic testing into psychiatric care, potentially improving treatment outcomes for a diverse patient population.

Who should consider this trial

Good fit: Ideal candidates include individuals suffering from moderate to severe mood disorders, anxiety disorders, or psychotic disorders as defined by specific diagnostic criteria.

Not a fit: Patients with mild psychiatric symptoms or those not meeting the severity criteria for inclusion may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more effective and tolerable treatments for millions of patients with psychiatric disorders.

How similar studies have performed: Previous studies have shown promising results with pharmacogenetic approaches in other medical fields, suggesting potential success in this novel application for psychiatric disorders.

Eligibility criteria

Inclusion Criteria:

1. 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).
2. 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.
3. 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.
4. Currently receiving inpatient or outpatient psychiatric treatment.
5. 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.
6. To give written consent to the use and disclosure of clinical data from their medical records for the purpose of this study.
7. Age between ≥16 and \<65 years.
8. Ownership of a mobile phone (Android or iOS operation system) for passive monitoring.

Exclusion Criteria:

1. Patients with a history of prior pharmacogenomic testing
2. Patients with no prior use of psychotropic medication (medication-naïve patients)
3. 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.
4. Alcohol and/or substance abuse and/or dependence (except nicotine)
5. 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).
6. Inability to use the mobile phone application
7. Pregnant or breastfeeding women

Where this trial is running

Syracuse, New York and 8 other locations

• SUNY Upstate Medical University, Department of Psychiatry and Behavioural Sciences — Syracuse, New York, United States (Not_yet_recruiting)
• University Hospital Bonn, Department of Psychiatry and Psychotherapy — Bonn, Germany (Recruiting)
• Ludwig-Maximilian University, University Hospital, Institute of Psychiatric Phenomics and Genomics (IPPG) — München, Germany (Recruiting)
• Parnassia Psychiatric Institute, Department of Psychiatry — Amsterdam, Netherlands (Recruiting)
• Maastricht University, Department of Psychiatry and Neuropsychology — Maastricht, Netherlands (Recruiting)
• Babeş-Bolyai University, Department of Clinical Psychology and Psychotherapy — Cluj-Napoca, Romania (Recruiting)
• University of Belgrade, Faculty of Pharmacy — Belgrade, Serbia (Recruiting)
• Fundació Clínic per a la Recerca Biomèdica, Department of Psychiatry and Psychology, Hospital Clínic — Barcelona, Spain (Recruiting)
• King's College, Institute of Psychiatry, Psychology & Neuroscience — London, United Kingdom (Recruiting)

Study contacts

• Principal investigator: Roos van Westrhenen, Ass. Prof. — Parnassia Psychiatric Institute (Amsterdam)
• Study coordinator: Roos van Westrhenen, Ass. Prof.

Conditions Mood Disorders; Anxiety Disorders; Psychotic Disorders; Pharmacogenetics