Anxiety and DepressionPGx-GAPNCT06853587
Pharmacogenetic-Guided Antidepressant Prescribing in Adolescents With Anxiety and Depression
A study testing Pharmacogenetic-guided dosing and Current prescribing guidelines/recommendations in people with Anxiety and Depression, run by University of Calgary at 1 site in Canada.
Trial summary
This is a parallel arm randomized (1:1) controlled trial. Adolescents aged 12-17 years (n=228) who are starting or changing a selective serotonin reuptake inhibitor (SSRI) for depression and/or anxiety will be randomly allocated to receive 12-weeks of pharmacogenetic-guided antidepressant therapy (experimental… Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Anxiety and Depression
- What is being tested?
- Pharmacogenetic-guided dosing and Current prescribing guidelines/recommendations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 228 participants
- Where
- 1 siteCanada
- Study dates
- 11 Feb 2025to Dec 2027
- 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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 12-17
- Depression and/or anxiety as the primary concern, confirmed by the treating physician
- Intention to start a new SSRI
- English fluency
Who cannot join
- Co-occurring obsessive compulsive disorder, psychosis, bipolar disorder, eating disorder, autism spectrum disorder, fetal alcohol spectrum disorder, or intellectual disability
- History of non-response to 3 or more SSRI medications as confirmed by the treating physician
- Brain stimulation-based therapy initiated within 8 weeks of referral, or plans to initiate/change brain stimulation during study participation
- History of liver or hematopoietic cell transplant
- History of CYP2B6, CYP2C19, or CYP2D6 testing
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
University of Calgary
Calgary, Alberta, T2N 4N1
Meagan Shields, BSc., MSc., 403-210-6353, gap@ucalgary.ca
Chad Bousman, PhD
About this study
This is a parallel arm randomized (1:1) controlled trial. Adolescents aged 12-17 years (n=228) who are starting or changing a selective serotonin reuptake inhibitor (SSRI) for depression and/or anxiety will be randomly allocated to receive 12-weeks of pharmacogenetic-guided antidepressant therapy (experimental intervention) or current prescribing guidelines/recommendations guided therapy (control intervention).
Read the detailed description
Goal: To test the efficacy of pharmacogenetic-guided antidepressant prescribing for adolescents with depression.
Background: For an adolescent with depression and anxiety, antidepressant medication is prescribed, often in combination with psychotherapy. The class of antidepressants recommended for use is selective serotonin reuptake inhibitors (SSRIs) with fluoxetine recommended as the first-line medication, and four other SSRIs recommended for consideration (sertraline, citalopram, escitalopram, fluvoxamine) if the adolescent does not respond or tolerate fluoxetine. For most adolescents, medication prescribing, and monitoring will be managed by a primary care physician or community pediatrician rather than by a mental health care provider, and guidelines exist to support this management. However, current prescribing guidelines/recommendations do not account for SSRI metabolism phenotypes that could change whether the SSRI selected is efficacious or tolerated. Our team of researchers, clinician scientists, patient partners, and primary care providers has designed a trial to test the impact of accounting for metabolism phenotypes, through pharmacogenetic-guided antidepressant prescribing, on adolescent outcomes, experiences, and health care utilization.
Principal Question: Compared to current prescribing guideline/recommendation informed prescribing, does pharmacogenetic-guided prescribing for adolescents with depression and/or anxiety have superior efficacy following 12-weeks of therapy with a SSRI?
The Trial: This is a parallel arm randomized controlled trial. Adolescents aged 12-17 years (n=228) who are starting or changing a SSRI for depression and/or anxiety will be randomly allocated to receive pharmacogenetic-guided antidepressant therapy (experimental intervention) or current prescribing guideline/recommendation guided prescribing (control intervention). Participants and prescribing physicians will be blinded to which intervention was received. The primary outcome is depressive symptom remission at 12 weeks measured using the Quick Inventory of Depressive Symptomatology - Adolescent (17-item) (QIDS-A17) and anxiety symptom remission at 12 weeks measures using the Screen for Child Anxiety Related Disorders (SCARED). Secondary outcomes include side effects, role functioning, medication adherence, and health-related quality of life measured 4-, 8-, and 12-weeks after intervention initiation as well as cost-effectiveness.
- Conditions
- Anxiety and Depression
- Being tested
- Pharmacogenetic-guided dosing, Current prescribing guidelines/recommendations
- Keywords
- depression, anxiety, adolescence, SSRI, antidepressant, pharmacogenetics
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacogenetic-guided dosingOther
SSRI dosing based on Clinical Pharmacogenetics Implementation Consortium's SSRI dosing guidelines.
Current prescribing guidelines/recommendationsOther
SSRI dosing based on current prescribing guidelines/recommendations
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Pharmacogenetic (PGx)-Guided | Experimental | Participants and their physician will receive a one-time prescribing report after completing baseline for selective serotonin reuptake inhibitors with dosing information based on CYP2B6, CYP2C19, and CYP2D6 genotype data, and clinical practice guidelines for fluoxetine as there are no pharmacogenetic guidelines for this medication. Receives: Other: Pharmacogenetic-guided dosing |
| Current Prescribing Guidelines/Recommendations | Active comparator | Participants and their physician will receive a one-time prescribing report after completing baseline for selective serotonin reuptake inhibitors based on current prescribing guidelines/recommendations. Receives: Other: Current prescribing guidelines/recommendations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with depression remission
Quick Inventory of Depressive Symptomatology - Adolescent - 17-item (QIDS-A17) total score < 6. Scores range from 0-27, with higher scores indicative of more severe depression.
Measured: Baseline to 12 weeks
Number of participants with anxiety remission
Screen for Child Anxiety Related Disorders (SCARED) total score < 25. Scores range from 0-82, with higher scores indicative of more severe anxiety.
Measured: Baseline to 12 weeks
Secondary outcomes (15)
Number of participants with side effects and adverse drug reactions
Frequency, Intensity, Burden of Side Effects Rating (FIBSER) scale. Total scores range from 0-6 (3 items); cut-points are used to indicate moderate (score of 3) or severe (score of 5) adverse drug reaction/side effect interference with activities.
Measured: Baseline to 12 weeks
Percent change in role functioning
WHO Disability Assessment Schedule. Scores range from 0 to 48, with higher scores indicative of worse role functioning.
Measured: Baseline to 12 weeks
Percent change in depressive symptom severity
Quick Inventory of Depressive Symptomatology - Adolescent - 17-item (QIDS-A17). Scores range from 0-27, with higher scores indicative of more severe depression.
Measured: Baseline to 12 weeks
Percent change in anxiety symptom severity
Screen for Child Anxiety Related Disorders (SCARED) total score < 25. Scores range from 0-82, with higher scores indicative of more severe anxiety.
Measured: Baseline to 12 weeks
Percent change in clinician assessment of depressive and anxiety symptom severity
Change in Clinical Global Impression Severity (CGI-S) scale. Scores range from 0-7, with higher scores indicative of more severe illness.
Measured: Baseline to 12 weeks
Change in self-report health care resource use
Resource use questionnaire that captures number of visits and out-of-pocket costs for various mental health services.
Measured: Baseline to 12 weeks
Change in healthcare utilization - physician visits
Administrative data will be obtained on change in number of physician visits.
Measured: Baseline to 12 weeks
Change in health care utilization - emergency department visits
Administrative data will be obtained on change in number of emergency department visits.
Measured: Baseline to 12 weeks
Change in health care utilization - hospitalizations
Administrative data will be obtained on change in number of hospitalizations.
Measured: Baseline to 12 weeks
Change in prescribed medication dose
Administrative data will be obtained on changes to prescribed medication doses.
Measured: Baseline to 12 weeks
Change in prescribed agent
Administrative data will be obtained on changes of agent for prescribed medications.
Measured: Baseline to 12 weeks
Change in prescribed medication duration
Administrative data will be obtained on duration of use of prescribed medications.
Measured: Baseline to 12 weeks
Change in health-related quality of life
EuroQoL 5 Dimension - Youth (EQ-5D-Y). Five descriptive items code level of perceived problems in health states and a visual analog scale has a score from 0-100, with higher scores indicative of better health.
Measured: Baseline to 12 weeks
Change in medication adherence
Medication Adherence Report Scale (MARS-5) scores. Scores range from 5-25 with higher scores indicative of better medication adherence.
Measured: 4 to 12 weeks
Change in behavioral activation
Emergence of activation based on Treatment-Emergent Activation and Suicidality Assessment Profile. Total scores range from 0-114 (38 items) with higher scores indicating greater behavioral activation.
Measured: Baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2025
- Study start11 Feb 2025
- Primary completionSep 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety and DepressionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a parallel arm randomized controlled trial.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 228 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 CalgaryAmanda Newton, PhD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06853587
- Sponsor's protocol ID
- 2025-23-0532
- Acronym
- PGx-GAP
- Status last verified
- Jun 2026
- First submitted
- 20 Feb 2025
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized, individual participant PGx-GAP data will be shared using a controlled-access model. Under this model, the data will be released to a researcher if access criteria are met. All requests for data sharing should be made to the Co-Principal Investigators who will be responsible for reviewing and granting requests. Requestors should provide a research proposal for review. In the event that a data sharing request is declined, reasons will be provided to the requestor. If the data sharing request is granted, a data-sharing agreement will be initiated by the Co-Principal Investigators alongside the University of Calgary (lead institution). This agreement will include information on the individual data to be shared; if other documents will be available (e.g., statistical codes, data dictionary), when the data will be available and for how long, and how data access will be provided (e.g., file transfer).
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacogenetic-Guided Antidepressant Prescribing in Adolescents With Anxiety and Depression
- ClinicalTrials.gov ID
- NCT06853587
- Acronym / sponsor ID
- PGx-GAP / 2025-23-0532
- Conditions
- Anxiety and Depression
- Keywords
- depression, anxiety, adolescence, SSRI, antidepressant, pharmacogenetics
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 228 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 11 Feb 2025 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 3 Mar 2025 (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.
This is a parallel arm randomized (1:1) controlled trial. Adolescents aged 12-17 years (n=228) who are starting or changing a selective serotonin reuptake inhibitor (SSRI) for depression and/or anxiety will be randomly allocated to receive 12-weeks of pharmacogenetic-guided antidepressant therapy (experimental intervention) or current prescribing guidelines/recommendations guided therapy (control intervention).
Detailed description
Goal: To test the efficacy of pharmacogenetic-guided antidepressant prescribing for adolescents with depression.
Background: For an adolescent with depression and anxiety, antidepressant medication is prescribed, often in combination with psychotherapy. The class of antidepressants recommended for use is selective serotonin reuptake inhibitors (SSRIs) with fluoxetine recommended as the first-line medication, and four other SSRIs recommended for consideration (sertraline, citalopram, escitalopram, fluvoxamine) if the adolescent does not respond or tolerate fluoxetine. For most adolescents, medication prescribing, and monitoring will be managed by a primary care physician or community pediatrician rather than by a mental health care provider, and guidelines exist to support this management. However, current prescribing guidelines/recommendations do not account for SSRI metabolism phenotypes that could change whether the SSRI selected is efficacious or tolerated. Our team of researchers, clinician scientists, patient partners, and primary care providers has designed a trial to test the impact of accounting for metabolism phenotypes, through pharmacogenetic-guided antidepressant prescribing, on adolescent outcomes, experiences, and health care utilization.
Principal Question: Compared to current prescribing guideline/recommendation informed prescribing, does pharmacogenetic-guided prescribing for adolescents with depression and/or anxiety have superior efficacy following 12-weeks of therapy with a SSRI?
The Trial: This is a parallel arm randomized controlled trial. Adolescents aged 12-17 years (n=228) who are starting or changing a SSRI for depression and/or anxiety will be randomly allocated to receive pharmacogenetic-guided antidepressant therapy (experimental intervention) or current prescribing guideline/recommendation guided prescribing (control intervention). Participants and prescribing physicians will be blinded to which intervention was received. The primary outcome is depressive symptom remission at 12 weeks measured using the Quick Inventory of Depressive Symptomatology - Adolescent (17-item) (QIDS-A17) and anxiety symptom remission at 12 weeks measures using the Screen for Child Anxiety Related Disorders (SCARED). Secondary outcomes include side effects, role functioning, medication adherence, and health-related quality of life measured 4-, 8-, and 12-weeks after intervention initiation as well as cost-effectiveness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a parallel arm randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Experimental: Pharmacogenetic (PGx)-Guided | Experimental | Other: Pharmacogenetic-guided dosingParticipants and their physician will receive a one-time prescribing report after completing baseline for selective serotonin reuptake inhibitors with dosing information based on CYP2B6, CYP2C19, and CYP2D6 genotype data, and clinical practice guidelines for fluoxetine as there are no pharmacogenetic guidelines for this medication. |
| Current Prescribing Guidelines/Recommendations | Active comparator | Other: Current prescribing guidelines/recommendationsParticipants and their physician will receive a one-time prescribing report after completing baseline for selective serotonin reuptake inhibitors based on current prescribing guidelines/recommendations. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age 12-17
- Depression and/or anxiety as the primary concern, confirmed by the treating physician
- Intention to start a new SSRI
- English fluency
Key exclusion criteria (5 listed)
- Co-occurring obsessive compulsive disorder, psychosis, bipolar disorder, eating disorder, autism spectrum disorder, fetal alcohol spectrum disorder, or intellectual disability
- History of non-response to 3 or more SSRI medications as confirmed by the treating physician
- Brain stimulation-based therapy initiated within 8 weeks of referral, or plans to initiate/change brain stimulation during study participation
- History of liver or hematopoietic cell transplant
- History of CYP2B6, CYP2C19, or CYP2D6 testing
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-guided dosingSSRI dosing based on Clinical Pharmacogenetics Implementation Consortium's SSRI dosing guidelines. | Other | Experimental: Pharmacogenetic (PGx)-Guided |
| Current prescribing guidelines/recommendationsSSRI dosing based on current prescribing guidelines/recommendations | Other | Current Prescribing Guidelines/Recommendations |
Primary outcome
Number of participants with depression remission
Time frame: Baseline to 12 weeks
Quick Inventory of Depressive Symptomatology - Adolescent - 17-item (QIDS-A17) total score < 6. Scores range from 0-27, with higher scores indicative of more severe depression.
Number of participants with anxiety remission
Time frame: Baseline to 12 weeks
Screen for Child Anxiety Related Disorders (SCARED) total score < 25. Scores range from 0-82, with higher scores indicative of more severe anxiety.
15 secondary outcomes
Number of participants with side effects and adverse drug reactions
Time frame: Baseline to 12 weeks
Percent change in role functioning
Time frame: Baseline to 12 weeks
Percent change in depressive symptom severity
Time frame: Baseline to 12 weeks
Percent change in anxiety symptom severity
Time frame: Baseline to 12 weeks
Percent change in clinician assessment of depressive and anxiety symptom severity
Time frame: Baseline to 12 weeks
Change in self-report health care resource use
Time frame: Baseline to 12 weeks
Change in healthcare utilization - physician visits
Time frame: Baseline to 12 weeks
Change in health care utilization - emergency department visits
Time frame: Baseline to 12 weeks
Change in health care utilization - hospitalizations
Time frame: Baseline to 12 weeks
Change in prescribed medication dose
Time frame: Baseline to 12 weeks
Change in prescribed agent
Time frame: Baseline to 12 weeks
Change in prescribed medication duration
Time frame: Baseline to 12 weeks
Change in health-related quality of life
Time frame: Baseline to 12 weeks
Change in medication adherence
Time frame: 4 to 12 weeks
Change in behavioral activation
Time frame: Baseline to 12 weeks
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 22 Jun 2026.
- Individual participant dataSharing planned: Yes. Anonymized, individual participant PGx-GAP data will be shared using a controlled-access model. Under this model, the data will be released to a researcher if access criteria are met. All requests for data sharing should be made to the Co-Principal Investigators who will be responsible for reviewing and granting requests. Requestors should provide a research proposal for review. In the event that a data sharing request is declined, reasons will be provided to the requestor. If the data sharing request is granted, a data-sharing agreement will be initiated by the Co-Principal Investigators alongside the University of Calgary (lead institution). This agreement will include information on the individual data to be shared; if other documents will be available (e.g., statistical codes, data dictionary), when the data will be available and for how long, and how data access will be provided (e.g., file transfer).
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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.
Chad Bousman, PhD principal investigator
University of Calgary
Amanda Newton, PhD principal investigator
University of Alberta
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-guided dosing and Current prescribing guidelines/recommendations in people with Anxiety and Depression, 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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 22 Jun 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?
Contact Madison Heintz, MSW (587-223-3154, gap@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with depression remission (time frame: Baseline to 12 weeks). 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?
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 22 Jun 2026.