Mental Health ImpairmentPGx-SParKNCT04797364
Pharmacogenetic Supported Prescribing in Kids
A study testing Pharmacogenetic Testing in people with Mental Health Impairment, run by University of Calgary at 1 site in Canada.
Trial summary
Implementation of pharmacogenetic testing for children and adolescents aged 6-24 who are starting or changing psychiatric medication. Read more about this study
- Who is it for?
- Ages 6 to 24 years
- Conditions the study is for
- Mental Health Impairment
- What is being tested?
- Pharmacogenetic Testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,000 participants
- Where
- 1 siteCanada
- Study dates
- 18 Jan 2021to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Medical records available
- The initiation, change, dose adjustment, or augmentation of psychiatric medication(s) is indicated
- Treating psychiatrist, family physician, or pediatrician licensed in Alberta, British Columbia, Saskatchewan, or Manitoba requests pharmacogenetic testing
Who cannot join
- Medically unstable or lacking capacity to provided informed consent
- Unwillingness of child to provide saliva sample for genetic analysis
- History of liver or bone marrow (hematopoietic cell) transplant
Trial locations and contacts
1 site in 1 country.
About this study
Implementation of pharmacogenetic testing for children and adolescents aged 6-24 who are starting or changing psychiatric medication.
Read the detailed description
Children with moderate to severe mental health conditions (e.g. depression, anxiety, OCD) or neurodevelopmental disorders (e.g., autism spectrum disorders, ADHD) are frequently prescribed medications as either the sole form of treatment or in combination with psychotherapy. However, up to 50% of these children will not respond or experience burdensome adverse drug reactions to these medications. Current use of mental health-related medications (e.g., antidepressants, antipsychotics) in children can be best described as a trial-and-error process that can impact the well-being of those taking the medications and their families at a considerable economic cost. However, this trial-and-error process could, in part, be avoided through the application of pharmacogenetic testing, a specific type of genetic testing that has the potential to improve drug efficacy and reduce the morbidity, mortality and cost associated with adverse drug reactions. The aim of this project is to implement and evaluate an evidence-based pharmacogenetic testing service to improve drug treatment outcomes in children receiving mental health care.
Our objectives are to:
- Implement Canada's first pharmacogenetics testing service to improve drug treatment outcomes in children receiving mental health care.
- Collect performance, outcome, and economic indicators related to the pharmacogenetics testing service.
- Establish a research platform for the discovery of new genetic and non-genetic markers of drug treatment outcomes relevant to mental health care in children.
- Conditions
- Mental Health Impairment
- Being tested
- Pharmacogenetic Testing
- Keywords
- Child, Adolescent, Mental Health, Psychiatry, Pharmacogenetics, Depression, Anxiety, OCD, Psychosis, Bipolar Disorder
- Medical subject headings
- Psychological Well-Being, Depression, Anxiety Disorders, Psychotic Disorders, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacogenetic TestingDiagnostic test
Participants will donate a 2ml (teaspoon) sample of saliva. DNA extracted from the saliva sample will be used for genotyping. Genotyping results will be translated into an interpretative clinical report using evidence-based software (Sequence2Script) developed by our group and delivered to the treating physician for use in their clinical decision-making. The report will contain genotyping results, predicted phenotype, and evidence-based drug selection and dosing recommendations relevant to the child's current and future care
| Study group | Role | What they receive |
|---|---|---|
| Pharmacogenetic Testing | Experimental | Pharmacogenetic testing panel (CYP2B6, CYP2C9, CYP2C19, CYP2D6, CYP3A5, NUDT15, SLCO1B1, TPMT, VKORC1) Receives: Diagnostic Test: Pharmacogenetic Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse drug reactions
Relative change in adverse drug reaction frequency
Measured: 6-months
Symptom severity
Relative change in symptom severity
Measured: 6-months
Secondary outcomes (1)
Healthcare utilization
Relative change in healthcare utilization
Measured: 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2021
- Study start18 Jan 2021
- Primary completion1 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mental Health ImpairmentStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chad Bousman, University of Calgary
- Investigators
- Chad Bousman, PhD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04797364
- Sponsor's protocol ID
- REB20-0900
- Acronym
- PGx-SParK
- Status last verified
- May 2026
- First submitted
- 9 Mar 2021
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Siu WS, Maruf AA, Shaheen SM, McCloud R, Heintz M, McAusland L, Arnold PD, Bousman CA. Estimating the Frequency of False-Negative Pharmacogenetic Test Results by Self-Reported Ancestry. Clin Pharmacol Ther. 2025 Aug;118(2):331-336. doi: 10.1002/cpt.3697. Epub 2025 Apr 27.
PubMed 40287944Bharthi K, Zuberi R, Maruf AA, Shaheen SM, McCloud R, Heintz M, McAusland L, Arnold PD, Bousman CA. Impact of Cytochrome P450 Genetic Variation on Patient-Reported Symptom Improvement and Side Effects Among Children and Adolescents Treated with Fluoxetine. J Child Adolesc Psychopharmacol. 2024 Feb;34(1):21-27. doi: 10.1089/cap.2023.0039.
PubMed 38377520
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacogenetic Supported Prescribing in Kids
- ClinicalTrials.gov ID
- NCT04797364
- Acronym / sponsor ID
- PGx-SParK / REB20-0900
- Conditions
- Mental Health Impairment
- Keywords
- Child, Adolescent, Mental Health, Psychiatry, Pharmacogenetics, Depression, Anxiety, OCD
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 18 Jan 2021 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 15 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Implementation of pharmacogenetic testing for children and adolescents aged 6-24 who are starting or changing psychiatric medication.
Detailed description
Children with moderate to severe mental health conditions (e.g. depression, anxiety, OCD) or neurodevelopmental disorders (e.g., autism spectrum disorders, ADHD) are frequently prescribed medications as either the sole form of treatment or in combination with psychotherapy. However, up to 50% of these children will not respond or experience burdensome adverse drug reactions to these medications. Current use of mental health-related medications (e.g., antidepressants, antipsychotics) in children can be best described as a trial-and-error process that can impact the well-being of those taking the medications and their families at a considerable economic cost. However, this trial-and-error process could, in part, be avoided through the application of pharmacogenetic testing, a specific type of genetic testing that has the potential to improve drug efficacy and reduce the morbidity, mortality and cost associated with adverse drug reactions. The aim of this project is to implement and evaluate an evidence-based pharmacogenetic testing service to improve drug treatment outcomes in children receiving mental health care.
Our objectives are to:
- Implement Canada's first pharmacogenetics testing service to improve drug treatment outcomes in children receiving mental health care.
- Collect performance, outcome, and economic indicators related to the pharmacogenetics testing service.
- Establish a research platform for the discovery of new genetic and non-genetic markers of drug treatment outcomes relevant to mental health care in children.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pharmacogenetic Testing | Experimental | Diagnostic Test: Pharmacogenetic TestingPharmacogenetic testing panel (CYP2B6, CYP2C9, CYP2C19, CYP2D6, CYP3A5, NUDT15, SLCO1B1, TPMT, VKORC1) |
Who may qualify
- Ages
- 6 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Medical records available
- The initiation, change, dose adjustment, or augmentation of psychiatric medication(s) is indicated
- Treating psychiatrist, family physician, or pediatrician licensed in Alberta, British Columbia, Saskatchewan, or Manitoba requests pharmacogenetic testing
Key exclusion criteria (3 listed)
- Medically unstable or lacking capacity to provided informed consent
- Unwillingness of child to provide saliva sample for genetic analysis
- History of liver or bone marrow (hematopoietic cell) transplant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmacogenetic TestingParticipants will donate a 2ml (teaspoon) sample of saliva. DNA extracted from the saliva sample will be used for genotyping. Genotyping results will be translated into an interpretative clinical report using evidence-based software (Sequence2Script) developed by our group and delivered to the treating physician for use in their clinical decision-making. The report will contain genotyping results, predicted phenotype, and evidence-based drug selection and dosing recommendations relevant to the child's current and future care | Diagnostic test | Pharmacogenetic Testing |
Primary outcome
Adverse drug reactions
Time frame: 6-months
Relative change in adverse drug reaction frequency
Symptom severity
Time frame: 6-months
Relative change in symptom severity
1 secondary outcome
Healthcare utilization
Time frame: 6-months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Derived from this study: PubMed 40287944Siu WS, Maruf AA, Shaheen SM, McCloud R, Heintz M, McAusland L, Arnold PD, Bousman CA. Estimating the Frequency of False-Negative Pharmacogenetic Test Results by Self-Reported Ancestry. Clin Pharmacol Ther. 2025 Aug;118(2):331-336. doi: 10.1002/cpt.3697. Epub 2025 Apr 27.
- Derived from this study: PubMed 38377520Bharthi K, Zuberi R, Maruf AA, Shaheen SM, McCloud R, Heintz M, McAusland L, Arnold PD, Bousman CA. Impact of Cytochrome P450 Genetic Variation on Patient-Reported Symptom Improvement and Side Effects Among Children and Adolescents Treated with Fluoxetine. J Child Adolesc Psychopharmacol. 2024 Feb;34(1):21-27. doi: 10.1089/cap.2023.0039.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chad Bousman, PhD principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacogenetic Testing in people with Mental Health Impairment, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse drug reactions (time frame: 6-months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04797364, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.