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

Qualifiers

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

Treatments tested in this trial

  • Personalised medication advice based on pharmacogenetic testing

Treatment groups

2,500 Participants
are divided into 2 treatment groups

Sponsors and collaborators

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