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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether genetic testing can help select better medications for mental health conditions. It focuses on how genes might affect the effectiveness and side effects of psychotropic medications, which treat mental disorders. Participants must be adults who are starting, changing, or adjusting their mental health medications and have been referred by their doctor. The trial involves providing a saliva sample for genetic analysis to determine if pharmacogenetic testing can personalize treatment.

As an unphased trial, this study offers participants the chance to contribute to innovative research that could lead to more personalized mental health treatments.

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 prior data suggests that pharmacogenetic testing is safe for adults with mental health disorders?

Studies have shown that pharmacogenetic testing is generally safe. This testing examines genes to help doctors choose the best medicine for each patient. Research indicates that this process usually does not harm patients. It uses DNA information to guide treatment decisions.

Pharmacogenetic testing supports mental health treatments, such as for depression and anxiety. While the testing itself is safe, it helps doctors avoid medicines that might not work well with a patient's body or could cause side effects. In this way, it makes treatments safer and more effective.

Overall, the testing is well-tolerated, with no reports of direct harmful effects. However, discussing any concerns with a healthcare provider is always important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about pharmacogenetic testing for mental health disorders because it personalizes treatment by analyzing your genetic makeup. Unlike standard treatments that often involve trial and error with medications like SSRIs or antipsychotics, this testing identifies which drugs are likely to work best for you based on your genes. This approach aims to reduce side effects and increase effectiveness, potentially leading to faster and more successful treatment outcomes for mental health conditions.

What evidence suggests that pharmacogenetic testing is effective for mental health disorders?

Research has shown that genetic testing, which examines how genes affect medication reactions, can help customize mental health treatments. In this trial, participants will undergo pharmacogenetic testing to assess its impact on treatment outcomes. One study found that individuals who underwent genetic testing were more likely to see symptom improvement after eight weeks compared to those who did not. This suggests they were more likely to feel better. Another report indicated that genetic testing might reduce the need to stop or change medications early. However, some studies have shown mixed results, with certain tests not always leading to better treatment choices for depression. Overall, while genetic testing is promising, its effectiveness can vary and may be more beneficial for some individuals than others. ^{1 2 6 7 8}

Who Is on the Research Team?

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

Principal Investigator

University of Manitoba

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. accpjournals.onlinelibrary.wiley.com accpjournals.onlinelibrary.wiley.com/doi/10.1002/jac5.1892

Pharmacogenomics to support mental health medication ... A promising approach to reduce early medication discontinuation or switching is through the strategic application of pharmacogenomics (PGx).

2. sciencedirect.com sciencedirect.com/science/article/pii/S0165032724007997

Effect of pharmacogenomic testing on the clinical treatment ... At week 8, the pharmacogenomic testing group showed significantly higher remission rates (24.0 % v.s. 15.1 %; RR = 1.117; P = 0.007) and ...

3. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2794053

Effect of Pharmacogenomic Testing for Drug-Gene ... Pharmacogenomic testing for drug-gene interactions in MDD reduced prescription of medications with predicted drug-gene interactions but had small and ...

4. psychiatryonline.org psychiatryonline.org/doi/full/10.1176/appi.ajp.20230657

Pharmacogenomic Clinical Support Tools for the Treatment ... The evidence does not support the use of currently available combinatorial PGx tools for treatment selection in major depressive disorder.

5. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK595332/

An Overview of Pharmacogenomic Testing for Psychiatric ... The findings suggested that the use of multigene pharmacogenomic testing to guide medication selection for major depression showed inconsistent effectiveness.

6. uhcprovider.com uhcprovider.com/content/dam/provider/docs/public/policies/medicaid-comm-plan/pharmacogenetic-testing-cs.pdf

Pharmacogenetic Panel Testing – Community Plan ... GeneSight is a pharmacogenomic gene panel test that assesses the interaction between genes and certain drugs for the purpose of aiding health ...

7. doc.uhealthplan.utah.edu doc.uhealthplan.utah.edu/medicalpolicy/mp-030.pdf

Pharmacogenomic Testing for Behavioral Health Disorders Some common types are major depressive disorder, anxiety, schizophrenia, bipolar disorder,. ADHD and Autism. In addition to counseling, treatment commonly ...

8. nature.com nature.com/articles/s44220-024-00240-2

A systematic review of pharmacogenetic testing to guide ... Here we conducted a systematic review to investigate whether pharmacogenetic testing in individuals undergoing antipsychotic treatment influences clinical or ...