Pharmacogenetic Testing for Mental Health Disorders

(PGx-SUPPORT Trial)

Recruiting at 1 trial location

Overseen By Abdullah Al Maruf, BPharm, MPharm, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Manitoba

Must be taking: Psychotropic medications

Disqualifiers: Liver transplant, Bone marrow transplant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 3 months

200 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on adjusting or changing medications, so you might continue with your current ones, but it's best to confirm with the study team.

What data supports the effectiveness of pharmacogenetic testing for mental health disorders?

Research suggests that pharmacogenetic testing, which looks at how genes affect a person's response to drugs, can help improve treatment outcomes in mental health by predicting how well a patient might respond to certain medications, especially in conditions like depression. This testing has shown potential in improving medication selection and reducing treatment costs. ^{1 2 3 4 5}

Is pharmacogenetic testing safe for mental health treatment?

Pharmacogenetic testing is generally considered safe and can help reduce negative side effects from medications by identifying how individuals metabolize drugs. Studies show that it can lead to fewer adverse drug reactions and improve medication management in mental health care. ^{1 6 7 8 9}

How does pharmacogenetic testing differ from other treatments for mental health disorders?

Pharmacogenetic testing is unique because it uses genetic information to predict how a person will respond to certain medications, helping to tailor treatments for mental health disorders like schizophrenia or bipolar disorder. This approach can improve medication effectiveness and reduce side effects by identifying the best drug and dosage for each individual. ^{1 2 7 10 11}

What is the purpose of this trial?

Investigate the feasibility and utility of implementing pharmacogenetic testing for adults (aged 18 and older) seeking care for mental illness in inpatient psychiatry clinics in Manitoba.

Research Team

Abdullah Al Maruf, PhD, M.Pharm., B.Pharm

Principal Investigator

University of Manitoba

Eligibility Criteria

This trial is for adults aged 18 and older who are seeking care for mental illness at inpatient psychiatry clinics in Manitoba. Specific eligibility criteria have not been provided, so it's best to contact the trial organizers for detailed information.

Inclusion Criteria

Presented for services within inpatient units in Manitoba

I need changes to my mental health medication.

My doctor believes genetic testing could help my treatment.

Exclusion Criteria

No personal health identification number (PHIN) is available

I am not willing to give saliva samples for genetic testing.

I have had a liver or bone marrow transplant.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Initial assessments including Clinical Global Impression Scale, Brief Psychiatric Rating Scale, and other baseline measures

1 week

1 visit (in-person)

Treatment

Participants undergo pharmacogenetic testing and receive psychotropic medication based on test results

3 months

Regular visits as per clinical need

Follow-up

Participants are monitored for changes in global functioning, symptom severity, and adverse drug experiences

3 months

Follow-up assessments at 3 months

Long-term Follow-up

Assessment of healthcare utilization and long-term outcomes

1 year

Treatment Details

Interventions

• Pharmacogenetic Testing

Trial Overview The study is exploring the use of pharmacogenetic testing—how genes affect a person's response to drugs—in prescribing psychotropic medication. It aims to see if this approach is practical and helpful in treating psychiatric disorders.

Participant Groups

Group I: Pharmacogenetic Testing Experimental Treatment 1 Intervention

Pharmacogenetic testing panel (CYP2C19, CYP2D6, CYP2B6, CYP3A4, CYP3A5, CYP2C9, CYP4F2, DPYD, HLA-A, HLA-B, NUDT15, SLCO1B1, TPMT, VKORC1, 2C Cluster, UGT1A1)

Who Is Running the Clinical Trial?

University of Manitoba

Lead Sponsor

Trials

628

Recruited

209,000+

University of Calgary

Collaborator

Trials

827

Recruited

902,000+

Shared Health Manitoba

Collaborator

Trials

1

Recruited

3,400+

Winnipeg Regional Health Authority

Collaborator

Trials

9

Recruited

1,900+

Health Sciences Centre, Winnipeg, Manitoba

Collaborator

Trials

18

Recruited

11,600+

Findings from Research

Pharmacogenomic testing is becoming a standard practice in psychiatry, helping to predict how patients will respond to medications for depression and other psychiatric conditions.

These tests have been shown to improve treatment outcomes and reduce healthcare costs for patients who do not respond well to standard treatments, while ongoing research is identifying new gene variants that may further enhance personalized treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacogenomics in Psychiatric Practice. El-Mallakh, RS., Roberts, RJ., El-Mallakh, PL., et al.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

The use of pharmacogenetic testing in patients with schizophrenia or bipolar disorder: A systematic review. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Pharmacogenetic-guided psychiatric intervention associated with increased adherence and cost savings. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Pharmacogenomics in Psychiatric Practice. [2019]

4. Netherlands pubmed.ncbi.nlm.nih.gov

The clinical validity and utility of combinatorial pharmacogenomics: Enhancing patient outcomes. [2021]

5. Argentina pubmed.ncbi.nlm.nih.gov

[Pharmacogenetics in psychiatry: how far are we from clinical application?]. [2012]

6. England pubmed.ncbi.nlm.nih.gov

Pharmacogenomics and Psychiatric Nursing. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Current applications of clinical genetic testing for psychiatric practice. [2009]

8. United States pubmed.ncbi.nlm.nih.gov

The INGENIOUS trial: Impact of pharmacogenetic testing on adverse events in a pragmatic clinical trial. [2023]

9. Germany pubmed.ncbi.nlm.nih.gov

Pharmacogenetics in Psychiatry. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Clinical and ethical considerations in pharmacogenetic testing: views of physicians in 3 "early adopting" departments of psychiatry. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Pharmacogenetic testing in psychiatry: a review of features and clinical realities. [2022]