Depression in AdolescencePGx-GAPNCT05965401
Pharmacogenetic-Guided Antidepressant Prescribing in Adolescents
A study testing Pharmacogenetic-guided dosing and GLAD-PC guided dosing in people with Depression in Adolescence, 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=452) who are starting or changing a selective serotonin reuptake inhibitor (SSRI) for depression will be randomly allocated to receive 12-weeks of pharmacogenetic-guided antidepressant therapy (experimental intervention) or… Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Depression in Adolescence
- What is being tested?
- Pharmacogenetic-guided dosing and GLAD-PC guided dosing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteCanada
- Study dates
- 25 Oct 2023to 2 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 as the primary concern, confirmed by the treating physician
- QIDS-A17 score greater than or equal to 11 indicating moderate-to-severe symptoms
- Intention to start a new SSRI
- English fluency
Who cannot join
- Co-occurring psychosis, bipolar disorder, eating disorder, autism spectrum disorder, fetal alcohol spectrum disorder, or intellectual disability
- A score of 2 or 3 on suicide item 13 of the QIDS-A17
- High-risk alcohol or substance use (excluding cannabis and tobacco) as indicated by a score of monthly or more on the S2BI
- 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.
About this study
Official title: Pharmacogenetic-Guided Antidepressant Prescribing (PGx-GAP) in Adolescents
This is a parallel arm randomized (1:1) controlled trial. Adolescents aged 12-17 years (n=452) who are starting or changing a selective serotonin reuptake inhibitor (SSRI) for depression will be randomly allocated to receive 12-weeks of pharmacogenetic-guided antidepressant therapy (experimental intervention) or GLAD-PC guided prescribing (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 moderate to severe depression, 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 (Guidelines for Adolescent Depression in Primary Care, GLAD-PC). However, GLAD-PC does 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 GLAD-PC informed prescribing, does pharmacogenetic-guided prescribing for depressed adolescents 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=452) who are starting or changing a SSRI for depression will be randomly allocated to receive pharmacogenetic-guided antidepressant therapy (experimental intervention) or GLAD-PC 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). 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
- Depression in Adolescence
- Being tested
- Pharmacogenetic-guided dosing, GLAD-PC guided dosing
- Keywords
- Depression, Adolescence, SSRI, Antidepressant, Pharmacogenetics
- Medical subject headings
- 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.
GLAD-PC guided dosingOther
SSRI dosing based on GLAD-PC clinical practice guidelines
| Study group | Role | What they receive |
|---|---|---|
| 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 GLAD-PC dosing guidelines for fluoxetine as there are no pharmacogenetic guidelines for this medication. Receives: Other: Pharmacogenetic-guided dosing |
| Guidelines for Adolescent Depression in Primary Care (GLAD-PC)-Guided | Active comparator | Participants and their physician will receive a one-time prescribing report after completing baseline for selective serotonin reuptake inhibitors based on GLAD-PC dosing guidelines. Receives: Other: GLAD-PC guided dosing |
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
Secondary outcomes (9)
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 clinician assessment of depressive 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 health care utilization
Administrative data will be obtained on medication information (agent, dose, duration) and health care utilization (doctor visits, hospitalizations, emergency room visits).
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 posted28 Jul 2023
- Study start25 Oct 2023
- Primary completion2 May 2025
- Study completion2 May 2025
Why it stopped: Low recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression in AdolescenceStudies 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
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alberta
- 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
- NCT05965401
- Sponsor's protocol ID
- REB23-0532
- Acronym
- PGx-GAP
- Status last verified
- May 2025
- First submitted
- 14 Jul 2023
- Last updated
- 20 May 2025
- 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 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacogenetic-Guided Antidepressant Prescribing (PGx-GAP) in Adolescents
- ClinicalTrials.gov ID
- NCT05965401
- Acronym / sponsor ID
- PGx-GAP / REB23-0532
- Conditions
- Depression in Adolescence
- Keywords
- Depression, Adolescence, SSRI, Antidepressant, Pharmacogenetics
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low recruitment
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- University of Alberta
- Study start
- 25 Oct 2023 (actual)
- Primary completion
- 2 May 2025 (actual)
- Study completion
- 2 May 2025 (actual)
- First posted
- 28 Jul 2023 (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=452) who are starting or changing a selective serotonin reuptake inhibitor (SSRI) for depression will be randomly allocated to receive 12-weeks of pharmacogenetic-guided antidepressant therapy (experimental intervention) or GLAD-PC guided prescribing (control intervention).
Detailed description
Goal: To test the efficacy of pharmacogenetic-guided antidepressant prescribing for adolescents with depression.
Background: For an adolescent with moderate to severe depression, 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 (Guidelines for Adolescent Depression in Primary Care, GLAD-PC). However, GLAD-PC does 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 GLAD-PC informed prescribing, does pharmacogenetic-guided prescribing for depressed adolescents 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=452) who are starting or changing a SSRI for depression will be randomly allocated to receive pharmacogenetic-guided antidepressant therapy (experimental intervention) or GLAD-PC 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). 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 |
|---|---|---|
| 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 GLAD-PC dosing guidelines for fluoxetine as there are no pharmacogenetic guidelines for this medication. |
| Guidelines for Adolescent Depression in Primary Care (GLAD-PC)-Guided | Active comparator | Other: GLAD-PC guided dosingParticipants and their physician will receive a one-time prescribing report after completing baseline for selective serotonin reuptake inhibitors based on GLAD-PC dosing guidelines. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Age 12-17
- Depression as the primary concern, confirmed by the treating physician
- QIDS-A17 score greater than or equal to 11 indicating moderate-to-severe symptoms
- Intention to start a new SSRI
- English fluency
Key exclusion criteria (7 listed)
- Co-occurring psychosis, bipolar disorder, eating disorder, autism spectrum disorder, fetal alcohol spectrum disorder, or intellectual disability
- A score of 2 or 3 on suicide item 13 of the QIDS-A17
- High-risk alcohol or substance use (excluding cannabis and tobacco) as indicated by a score of monthly or more on the S2BI
- 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
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 | Pharmacogenetic (PGx)-Guided |
| GLAD-PC guided dosingSSRI dosing based on GLAD-PC clinical practice guidelines | Other | Guidelines for Adolescent Depression in Primary Care (GLAD-PC)-Guided |
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.
9 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 clinician assessment of depressive symptom severity
Time frame: Baseline to 12 weeks
Change in self-report health care resource use
Time frame: Baseline to 12 weeks
Change in health care utilization
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
The study was stopped early (reason given: Low recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2025.
- 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. This study is not recruiting at the moment.
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 GLAD-PC guided dosing in people with Depression in Adolescence, 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 5 inclusion and 7 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: stopped early, as of the sponsor's last update on 20 May 2025. 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?
The study was stopped early (reason given: Low recruitment). Results are not available in the source record.
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?
Number of participants with depression remission (time frame: Baseline to 12 weeks). 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 20 May 2025.