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Pharmacogenomics

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

PSY-PGx Trial 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.Check my eligibility

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.See study design

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.

PSY-PGx Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

Burden of side effects, as measured by

General wellbeing, as measured by

Psychosocial functioning, as measured by

+7 more

Other outcome measures

Passive behavioral monitoring using the BeHAPP mobile application.

PSY-PGx 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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Maastricht University Medical CenterLead Sponsor

954 Previous Clinical Trials

3,261,382 Total Patients Enrolled

University of BonnOTHER

54 Previous Clinical Trials

44,208 Total Patients Enrolled

State University of New York - Upstate Medical UniversityOTHER

173 Previous Clinical Trials

24,892 Total Patients Enrolled

Media Library

Personalised medication advice based on pharmacogenetic testing (Pharmacogenomics) Clinical Trial Eligibility Overview. Trial Name: NCT05656469 — N/A

Mood Disorders Research Study Groups: PSY-PGx Group, Dosing as usual (DAU) group

Mood Disorders Clinical Trial 2023: Personalised medication advice based on pharmacogenetic testing Highlights & Side Effects. Trial Name: NCT05656469 — N/A

Personalised medication advice based on pharmacogenetic testing (Pharmacogenomics) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05656469 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is eligibility for this research project confined to individuals below the age of 45?

"This clinical trial's parameters stipulate that the participating patient must be between 16 and 65 years of age. Simultaneously, there are 422 studies being conducted for minors and 1033 trials taking place with seniors as participants."

Answered by AI

Is enrollment into this experiment still open?

"According to records hosted on clinicaltrials.gov, this specific trial is no longer recruiting participants; the initial post date was December 1st 2022 with a recent update occurring on the 9th of that month. Fortunately, there are presently 1588 other trials searching for volunteers across the world."

Answered by AI

Is it possible to join this medical experiment?

"This trial is seeking 2500 individuals aged 16 to 65 who suffer from a mental health condition, such as major depressive disorder, bipolar disorder (with current episode of depression), panic disorder or generalised anxiety disorder. Such participants must have had an inadequate response to at least one psychotropic treatment and are currently receiving inpatient or outpatient psychiatric care. Furthermore, they should be willing to switch their medication either sertraline/escitalopram for mood/anxiety disorders or aripiprazole/risperidone for psychotic disorders within the last 2 weeks prior to contact with an investigator. Finally, applicants need possess basic understanding about this"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Clinical Study Evaluating Pharmacogenomics-informed Pharmacotherapy Versus Dosing as Usual in Psychiatric Disorders". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05656469.

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