Actively Recruiting

Phase Not Applicable
Age: 16Years - 65Years
All Genders
NCT05656469

Clinical Study Evaluating Pharmacogenomics-informed Pharmacotherapy Versus Dosing as Usual in Psychiatric Disorders

Led by Maastricht University Medical Center · Updated on 2026-02-05

2500

Participants Needed

9

Research Sites

183 weeks

Total Duration

On this page

Sponsors

M

Maastricht University Medical Center

Lead Sponsor

P

Parnassia Psychiatric Institute

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Clinical Study Evaluating Pharmacogenomics-informed Pharmacotherapy Versus Dosing as Usual in Psychiatric Disorders

Who Can Participate

Age: 16Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Suffer from a depressive episode (major depressive disorder or bipolar disorder currently depressive) of moderate or higher severity assessed by standardized interviews and scales, and/or an anxiety disorder (panic or generalized anxiety disorder) of moderate or higher severity, and/or a psychotic disorder (schizophrenia or schizoaffective disorder) of moderate or higher severity
  • Have had an inadequate response to at least one psychotropic treatment in their lifetime, defined as insufficient efficacy despite adequate dosing or discontinuation due to side effects
  • Are about to switch or have switched within the last 2 weeks to sertraline or escitalopram (for mood or anxiety disorders), or aripiprazole or risperidone (for psychotic disorders) due to inadequate response or intolerance
  • Currently receiving inpatient or outpatient psychiatric treatment
  • Able to understand study requirements and provide written informed consent
  • Provide written consent for use and disclosure of clinical data for the study
  • Age between 16 and less than 65 years
  • Own a mobile phone (Android or iOS) for passive monitoring
Not Eligible

You will not qualify if you...

  • History of prior pharmacogenomic testing
  • No prior use of psychotropic medication (medication-naïve)
  • Severe somatic comorbidities detected by medical history or recent clinical tests including liver disease (ALAT > 70u/L), renal disease (eGFR < 60 ml/min/1.73m2), diabetes (blood glucose > 11.1 mmol/L or two fasting glucose > 7.0 mmol/L), or cardiac disease (prolonged QT-interval)
  • Alcohol or substance abuse or dependence (except nicotine)
  • Polypharmacy defined as routine use of five or more medications including over-the-counter, prescription, or traditional/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

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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

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Research Team

R

Roos van Westrhenen, Ass. Prof.

CONTACT

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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