6000 Participants Needed

Genetic-Guided Medication for Mental Health Disorders in Children

(PGx-SParK Trial)

LM
Overseen ByLaina McAusland, MSc
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: University of Calgary
Must be taking: Psychiatric medications
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

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.12345

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.12367

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.12348

Research Team

CB

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 OverviewThe 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
1Treatment groups
Experimental Treatment
Group I: Pharmacogenetic TestingExperimental Treatment1 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:

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Approved in United States as Pharmacogenetic Testing for:
  • Guidance for certain medications like carbamazepine, valproic acid, and tetrabenazine
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Approved in Canada as Pharmacogenetic Testing for:
  • Guidance for certain medications like carbamazepine, valproic acid, and tetrabenazine
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Approved in European Union as Pharmacogenetic Testing for:
  • Guidance for certain medications, but specific indications vary by country

Find a Clinic Near You

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

References

Utility of pharmacogenetic testing to optimise antidepressant pharmacotherapy in youth: a narrative literature review. [2023]
Pharmacogenomics: an Update for Child and Adolescent Psychiatry. [2020]
Child and Adolescent Psychiatrists' Use, Attitudes, and Understanding of Genetic Tests in Clinical Practice. [2023]
Pharmacogenomics and the Management of Mood Disorders-A Review. [2023]
Clinical Impact of Pharmacogenetic-Guided Treatment for Patients Exhibiting Neuropsychiatric Disorders: A Randomized Controlled Trial. [2018]
Assessment of the Implementation of Pharmacogenomic Testing in a Pediatric Tertiary Care Setting. [2022]
Pharmacogenetics in psychiatry: translating research into clinical practice. [2021]
Pharmacogenomic testing for mental health (Part II): qualitative analysis of early adopter prescriber perceptions. [2021]