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

Trial Summary

What is the purpose of this trial?

Implementation of pharmacogenetic testing for children and adolescents aged 6-24 who are starting or changing psychiatric medication.

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

Research shows that pharmacogenetic testing can improve the effectiveness of mental health treatments by tailoring medications to a child's genetic makeup, which can enhance drug efficacy and reduce side effects. Studies in youth psychiatry indicate that this personalized approach can lead to better treatment outcomes compared to the traditional trial-and-error method. ^{1 2 3 4 5}

Is genetic-guided medication safe for children with mental health disorders?

Pharmacogenetic testing, which helps tailor medications based on a person's genetic makeup, has shown promise in making drug treatments safer by reducing side effects and adverse reactions. This approach is particularly useful for children who take multiple medications and are at higher risk for side effects. ^{1 2 3 6 7}

How is pharmacogenetic testing different from other treatments for mental health disorders in children?

Pharmacogenetic testing is unique because it uses a child's genetic information to tailor medication choices, aiming to improve effectiveness and reduce side effects, unlike the traditional trial-and-error approach. ^{1 2 3 4 8}

Research Team

Chad Bousman

Principal Investigator

University of Calgary

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Utility of pharmacogenetic testing to optimise antidepressant pharmacotherapy in youth: a narrative literature review. [2023]

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

Pharmacogenomics: an Update for Child and Adolescent Psychiatry. [2020]

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

Child and Adolescent Psychiatrists' Use, Attitudes, and Understanding of Genetic Tests in Clinical Practice. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Pharmacogenomics and the Management of Mood Disorders-A Review. [2023]

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

Clinical Impact of Pharmacogenetic-Guided Treatment for Patients Exhibiting Neuropsychiatric Disorders: A Randomized Controlled Trial. [2018]

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

Assessment of the Implementation of Pharmacogenomic Testing in a Pediatric Tertiary Care Setting. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Pharmacogenetics in psychiatry: translating research into clinical practice. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Pharmacogenomic testing for mental health (Part II): qualitative analysis of early adopter prescriber perceptions. [2021]