Genetic-Guided Medication for Mental Health Disorders in Children

(PGx-SParK Trial)

Overseen By Laina McAusland, MSc

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Calgary

Must be taking: Psychiatric medications

Disqualifiers: Medically unstable, Liver transplant, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

6000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how genetic testing (pharmacogenetic testing) can tailor psychiatric medications for children and teens. Researchers test specific genes to determine their impact on medication efficacy in the body. This approach could lead to more effective and personalized treatments for mental health conditions. Children or teens who are about to start, change, or adjust their psychiatric medication and can provide a saliva sample for genetic analysis may be suitable candidates for the trial. As an unphased trial, participants contribute to groundbreaking research that could revolutionize mental health treatment for young people.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop your current medications. It focuses on starting or changing psychiatric medications, so you may be able to continue your current ones, but it's best to confirm with the trial coordinators.

What prior data suggests that pharmacogenetic testing is safe for children and adolescents?

Research shows that genetic testing can enhance the effectiveness and safety of psychiatric medications for young people. This testing helps doctors select medicines that align with a person's genetic profile, reducing the risk of side effects. One study found that many child and adolescent psychiatrists use this testing to customize treatment for each patient. Although specific safety data for this trial is unavailable, these findings suggest that genetic testing is widely accepted and beneficial in safely managing mental health treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Pharmacogenetic testing is unique because it personalizes medication management for mental health disorders in children by analyzing their genetic makeup. Unlike traditional treatments that often rely on trial and error to find the right medication and dosage, this approach uses genetic information to predict how a child will respond to specific drugs. This can lead to more effective and safer treatment plans, minimizing side effects and reducing the time it takes to find the right medication. Researchers are excited because this method has the potential to revolutionize how mental health conditions are treated, making therapies more tailored and precise.

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

Research has shown that genetic testing, which examines how a person's genes affect their response to medications, can enhance the safety and effectiveness of psychiatric treatments for children and teens. In this trial, participants will undergo pharmacogenetic testing, which includes a panel of genes such as CYP2B6, CYP2C9, CYP2C19, CYP2D6, CYP3A5, NUDT15, SLCO1B1, TPMT, and VKORC1. Studies indicate that about 73% of child psychiatrists find this testing at least somewhat helpful in managing mental health medications. This testing can customize treatments based on an individual's genetic makeup, potentially reducing the need to change medications early on. The broader field of pharmacogenomics, which includes genetic testing, has shown promise in reducing medication changes and improving therapy choices. These personalized approaches may lead to better outcomes for young patients starting or changing psychiatric medications. ^{1 2 3 4 6}

Who Is on the Research Team?

Chad Bousman

Principal Investigator

University of Calgary

Are You a Good Fit for This Trial?

This trial is for children and adolescents aged 6-24 in Alberta, British Columbia, Saskatchewan, or Manitoba who are starting or changing psychiatric medication. They must have medical records available and a licensed psychiatrist or physician requesting the test. Those with unstable health conditions, inability to consent, reluctance to give a saliva sample, or history of certain transplants cannot join.

Inclusion Criteria

I need changes to my psychiatric medication.

Medical records available

My doctor in Alberta, BC, Saskatchewan, or Manitoba has requested a genetic test for my medication.

Exclusion Criteria

My child is not willing to give a saliva sample for genetic testing.

I have had a liver or bone marrow transplant.

I am medically stable and able to understand and agree to study procedures.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pharmacogenetic Testing

Implementation of pharmacogenetic testing for children and adolescents starting or changing psychiatric medication

6 months

Regular visits as needed for testing and monitoring

Follow-up

Participants are monitored for safety and effectiveness after pharmacogenetic testing

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Pharmacogenetic Testing

Trial Overview The study is testing whether using pharmacogenetic testing (looking at how genes affect a person's response to drugs) can help in prescribing the right psychiatric medications for kids when they're either starting new meds or adjusting current ones.

How Is the Trial Designed?

Group I: Pharmacogenetic Testing Experimental Treatment 1 Intervention

Pharmacogenetic testing panel (CYP2B6, CYP2C9, CYP2C19, CYP2D6, CYP3A5, NUDT15, SLCO1B1, TPMT, VKORC1)

Pharmacogenetic Testing is already approved in United States, Canada, European Union for the following indications:

Approved in United States as Pharmacogenetic Testing for:

• Guidance for certain medications like carbamazepine, valproic acid, and tetrabenazine

Approved in Canada as Pharmacogenetic Testing for:

• Guidance for certain medications like carbamazepine, valproic acid, and tetrabenazine

Approved in European Union as Pharmacogenetic Testing for:

• Guidance for certain medications, but specific indications vary by country

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials

827

Recruited

902,000+

Published Research Related to This Trial

Over half (54.9%) of child and adolescent psychiatrists surveyed reported ordering or referring for genetic testing in the past year, indicating that genetic testing is becoming a routine part of clinical care in this field.

Despite the high usage of pharmacogenetic (PGx) testing, 45% of psychiatrists rated their knowledge of genetic testing guidelines as poor, highlighting a significant gap in education that could lead to misinterpretation and unnecessary changes in treatment plans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Child and Adolescent Psychiatrists' Use, Attitudes, and Understanding of Genetic Tests in Clinical Practice. Soda, T., Merner, AR., Small, BJ., et al.[2023]

Pharmacogenomic (PGx) testing is utilized by prescribers to tailor medication for patients with depression and ADHD, especially in cases of multiple comorbidities or treatment-resistant conditions.

The effectiveness of PGx testing in clinical practice is influenced by factors such as insurance coverage, the clarity of test results, and how quickly results are available, helping to address patient concerns about side effects and treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacogenomic testing for mental health (Part II): qualitative analysis of early adopter prescriber perceptions. Manzor Mitrzyk, B., Plegue, MA., Kadri, R., et al.[2021]

In a study of 172 children at The Hospital for Sick Children, pharmacogenomic (PGx) testing revealed that 36.8% of patients in the point-of-care cohort had genetic profiles that required changes to their standard medication dosages, highlighting the importance of personalized medicine.

In the preemptive cohort, 80% of children were advised to follow nonstandard treatment regimens based on whole-genome sequencing, demonstrating the potential of PGx testing to optimize drug therapy and reduce adverse reactions in pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of the Implementation of Pharmacogenomic Testing in a Pediatric Tertiary Care Setting. Cohn, I., Manshaei, R., Liston, E., et al.[2022]

Pharmacogenomics (PGX) has potential in guiding medication selection for children and adolescents, particularly with genes like CYP2D6, CYP2C19, HLA-A, and HLA-B showing the strongest evidence for pharmacotherapy.

Despite the evolving nature of PGX, traditional evidence-based medicine remains the primary approach for medication selection in pediatric psychiatry, as the application of PGX in younger populations is still under-researched.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacogenomics: an Update for Child and Adolescent Psychiatry. Namerow, LB., Walker, SA., Loftus, M., et al.[2020]

Pharmacogenetic (PGx) approaches in psychiatry have not yet produced strong results for predicting drug efficacy or side effects, leading to limited clinical use of PGx testing in this field.

To improve the effectiveness of PGx studies, researchers suggest focusing on early-stage patients, using drug-induced side effects as study targets, and ensuring high treatment adherence among participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacogenetics in psychiatry: translating research into clinical practice. Malhotra, AK., Zhang, JP., Lencz, T.[2021]

Pharmacogenetic (PGx) testing can significantly improve treatment outcomes for patients with mental disorders like depression by identifying genetic factors that influence drug metabolism and response, potentially benefiting millions.

Genotyping for specific enzymes, such as CYP2D6 and CYP2C19, is recommended when patients experience side effects or ineffective treatment, moving away from the traditional trial-and-error approach in psychiatric medication selection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacogenomics and the Management of Mood Disorders-A Review. Kleine Schaars, K., van Westrhenen, R.[2023]

Pharmacogenetics (PGx) testing can personalize psychiatric treatment by tailoring drug prescriptions based on individual genetic differences, potentially improving drug efficacy and reducing adverse reactions.

Despite evidence from randomized controlled trials supporting PGx testing in psychiatry, especially for youth mental health, there are significant barriers to its implementation in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utility of pharmacogenetic testing to optimise antidepressant pharmacotherapy in youth: a narrative literature review. Roberts, B., Cooper, Z., Lu, S., et al.[2023]

In a study of 237 patients with neuropsychiatric disorders, pharmacogenetic (PGx) testing led to a significant reduction in adverse drug events, with only 28% of patients experiencing side effects compared to 53% in the standard care group.

While both PGx-guided treatment and standard care showed improvements in neuropsychiatric symptoms, there was no significant difference in overall efficacy between the two approaches over the 90-day period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Impact of Pharmacogenetic-Guided Treatment for Patients Exhibiting Neuropsychiatric Disorders: A Randomized Controlled Trial. Olson, MC., Maciel, A., Gariepy, JF., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12389199/

Pharmacogenetic Testing of Children and Adolescents with ... PGx testing has been proposed as a way to improve treatment safety and efficacy; however, in clinical practice it is often reserved for children ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S016517812300197X

Child and adolescent psychiatrists' use, attitudes, and ... The most ordered test was PGx (32.2%), followed by chromosomal microarray (23.0%). 73.4% reported that PGx is at least slightly useful in child and adolescent ...

3. digitalcommons.fiu.edu digitalcommons.fiu.edu/cgi/viewcontent.cgi?article=1263&context=cnhs-studentprojects

Assessing Utilization and Outcomes of Pharmacogenomic ... Implementing pharmacogenomic testing to identify MTHFR variations can lead to effective alternative therapies (Gardner et al., 2014). Page 9. 8.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5828875/

Pharmacogenomic Testing in Child & Adolescent Psychiatry Abstract. Significant advances have been made in the application of pharmacogenomic testing for the treatment of patients with psychiatric disorders.

5. 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).

6. clinicaltrials.gov clinicaltrials.gov/study/NCT02855580

Integrating Pharmacogenomic Testing Into a Child ... The purpose of this study is to examine the feasibility, acceptability, and utility of pharmacogenomic (PGX) testing (specifically for the cytochrome P450 2D6 ...