Pharmacogenomics-informed Pharmacotherapy for Psychiatric Disorders (PSY-PGx Trial)

N/A

Recruiting

Led By Bea Campforts, Msc

Research Sponsored by Maastricht University Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if personalized medicine helps psychiatric patients better than usual treatments.

Who is the study for?

This trial is for individuals aged 16-65 with mood, anxiety, or psychotic disorders who are switching to specific medications due to inadequate response or intolerance. Participants must be currently receiving psychiatric treatment and own a smartphone for monitoring. Exclusions include prior pharmacogenomic testing, certain medical conditions like liver disease, diabetes, cardiac issues, polypharmacy use, pregnancy/breastfeeding women, medication-naïve patients and substance abuse.

What is being tested?

The study tests personalized medication advice based on genetic testing against standard dosing in treating psychiatric disorders over 24 weeks. It's blinded and randomized: neither the participants nor the raters know who gets which treatment until after the results are collected.

What are the potential side effects?

While not specified here, potential side effects may relate to the medications sertraline or escitalopram (for mood/anxiety) and aripiprazole or risperidone (for psychosis), which can include nausea, headaches, sleep disturbances among others depending on individual reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Patient recovery, as assessed using the Patient Recovery Assessment scale - Domains and Stages (RAS-DS).

Secondary study objectives

Burden of side effects, as measured by

General wellbeing, as measured by

Psychosocial functioning, as measured by

+7 more

Other study objectives

Passive behavioral monitoring using the BeHAPP mobile application.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: PSY-PGx GroupExperimental Treatment1 Intervention

This is the intervention group. All patients will be treated according to a personalised medication recommendation based on the results of pharmacogenetic testing, following the prespecified dosing guideline. Prescribing physicians will prescribe one of the predefined drugs and will be unblinded for genotype and the resulting metabolisation phenotype.

Group II: Dosing as usual (DAU) groupActive Control1 Intervention

This is the control group. In this group, prescribing physicians will also prescribe one of the predefined drugs, but will remain blinded to their patients' genotype and resulting metabolism phenotype for the duration of their participation in the study. After the study, patients in the control group will also be given their pharmacogenetic profile, which will make it possible to personalise their medication if necessary.

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