Pharmacogenetic-Guided Antidepressant Prescribing (PGx-GAP) in Adolescents
Trial testing if genetic testing can improve antidepressant treatment for teens with depression.
Plain English Summary
Pharmacogenetic-Guided Antidepressant Prescribing in Adolescents is a Not Applicable clinical trial sponsored by University of Calgary studying Depression in Adolescence. This trial tests if using genetic information can help doctors choose the best antidepressant for teenagers with depression. It is for adolescents aged 12-17 who are experiencing moderate to severe depression and are starting or changing an SSRI antidepressant. Participants will be randomly assigned to either receive an antidepressant guided by their genetics or by standard clinical guidelines. Standard care for depression includes therapy and medication, with doctors choosing SSRIs based on patient symptoms and medical history. The trial aims to enroll 11 participants.
Official 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 GLAD-PC guided prescribing (control intervention).
Who Can Participate
Here is what you need to know about eligibility for this trial. Adolescents aged 12 to 17 years old. Must have moderate to severe depression confirmed by a doctor. Must be starting a new SSRI antidepressant. Cannot have certain other mental health conditions like psychosis or bipolar disorder, or severe substance use issues. This trial is studying Depression in Adolescence, so participants generally need a confirmed diagnosis.
What They're Measuring
The primary outcome measures how many participants no longer have depression symptoms after 12 weeks, indicating if the genetic-guided approach is more effective. The specific primary outcome measures are: Number of participants with depression remission (Baseline to 12 weeks). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial aims to fill a gap in treatment by personalizing antidepressant selection for adolescents, potentially leading to faster and more effective symptom relief. This research targets Depression in Adolescence, where improved treatment options are needed.
Investor Insight
This trial explores a personalized medicine approach in a large market for adolescent mental health, with potential for improved treatment outcomes and reduced healthcare costs if successful.
Is This Trial Right for Me?
Ask your doctor if genetic testing is right for you and how it might affect your treatment. Participation involves taking an antidepressant as prescribed and attending regular study visits for 12 weeks. You will be randomly assigned to one of two treatment groups. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: QUADRUPLE
- Enrollment: 11 participants
Interventions
- OTHER: Pharmacogenetic-guided dosing — SSRI dosing based on Clinical Pharmacogenetics Implementation Consortium's SSRI dosing guidelines.
- OTHER: GLAD-PC guided dosing — SSRI dosing based on GLAD-PC clinical practice guidelines
Primary Outcomes
- Number of participants with depression remission (Baseline to 12 weeks)
Secondary Outcomes
- Number of participants with side effects and adverse drug reactions (Baseline to 12 weeks)
- Percent Change in Role functioning (Baseline to 12 weeks)
- Percent Change in Depressive Symptom Severity (Baseline to 12 weeks)
- Percent Change in clinician assessment of depressive symptom severity (Baseline to 12 weeks)
- Change in self-report health care resource use (Baseline to 12 weeks)
Full Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
- University of Calgary, Calgary, Alberta, Canada
Frequently Asked Questions
What is clinical trial NCT05965401?
NCT05965401 is a Not Applicable INTERVENTIONAL study titled "Pharmacogenetic-Guided Antidepressant Prescribing in Adolescents." It is currently terminated and is sponsored by University of Calgary. The trial targets enrollment of 11 participants.
What conditions does NCT05965401 study?
This trial investigates treatments for Depression in Adolescence. The primary condition under study is Depression in Adolescence.
What treatments are being tested in NCT05965401?
The interventions being studied include: Pharmacogenetic-guided dosing (OTHER), GLAD-PC guided dosing (OTHER). SSRI dosing based on Clinical Pharmacogenetics Implementation Consortium's SSRI dosing guidelines.
What does Not Applicable mean for NCT05965401?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT05965401?
This trial is currently "Terminated." It started on 2023-10-25. The estimated completion date is 2025-05-02.
Who is sponsoring NCT05965401?
NCT05965401 is sponsored by University of Calgary. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT05965401?
The trial aims to enroll 11 participants. The trial status is terminated.
How is NCT05965401 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs quadruple masking. Masking means some participants and/or investigators do not know which treatment group a participant is in, which helps reduce bias.
What are the primary outcomes being measured in NCT05965401?
The primary outcome measures are: Number of participants with depression remission (Baseline to 12 weeks). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT05965401 being conducted?
This trial is being conducted at 1 site, including Calgary, Alberta (Canada).
Where can I find official information about NCT05965401?
The official record for NCT05965401 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT05965401. This government database provides the most up-to-date and detailed information about the trial.
What is NCT05965401 testing in simple terms?
This trial tests if using genetic information can help doctors choose the best antidepressant for teenagers with depression. It is for adolescents aged 12-17 who are experiencing moderate to severe depression and are starting or changing an SSRI antidepressant.
Why is this trial significant?
This trial aims to fill a gap in treatment by personalizing antidepressant selection for adolescents, potentially leading to faster and more effective symptom relief.
What are the potential risks of participating in NCT05965401?
Potential side effects of antidepressants include nausea, headache, and sleep disturbances. Genetic testing itself carries no direct physical risks, but results may influence treatment decisions. There is a small risk of worsening depression or suicidal thoughts, which will be closely monitored. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT05965401?
Ask your doctor if genetic testing is right for you and how it might affect your treatment. Participation involves taking an antidepressant as prescribed and attending regular study visits for 12 weeks. You will be randomly assigned to one of two treatment groups. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT05965401 signal from an investment perspective?
This trial explores a personalized medicine approach in a large market for adolescent mental health, with potential for improved treatment outcomes and reduced healthcare costs if successful. This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participants will be randomly assigned to either receive an antidepressant guided by their genetics or by standard clinical guidelines. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
More Depression in Adolescence Trials
This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.