Pharmacogenetic-Guided Antidepressant Prescribing in Adolescents With Anxiety and Depression
Personalized Antidepressant Treatment for Anxious Teens
Plain English Summary
Pharmacogenetic-Guided Antidepressant Prescribing in Adolescents With Anxiety and Depression is a Not Applicable clinical trial sponsored by University of Calgary studying Anxiety and Depression. This trial tests if using genetic information can help doctors choose the best antidepressant for teenagers with anxiety and depression. It is for adolescents aged 12-17 who are experiencing depression and/or anxiety and are starting or changing an SSRI medication. Participants will be randomly assigned to either receive antidepressant treatment guided by their genetics or by standard guidelines. The alternative is standard care, where doctors prescribe based on general recommendations without genetic testing. The trial aims to enroll 452 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 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).
Who Can Participate
Here is what you need to know about eligibility for this trial. Teens aged 12 to 17 years can join. They must have depression and/or anxiety as their main health concern, confirmed by their doctor. They should be planning to start a new type of antidepressant called an SSRI. Individuals with certain other conditions like OCD, psychosis, bipolar disorder, or intellectual disabilities cannot join. This trial is studying Anxiety and Depression, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The main goal is to see if more teenagers achieve remission, meaning their depression and anxiety symptoms significantly improve or disappear, when treatment is guided by their genetic profile. The specific primary outcome measures are: Number of participants with depression remission (Baseline to 12 weeks); Number of participants with anxiety 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 improve how antidepressants work for young people by tailoring treatment to their unique genetic makeup, addressing a gap in personalized mental healthcare. This research targets Anxiety and Depression, where improved treatment options are needed.
Investor Insight
This study explores a novel approach to mental health treatment, potentially leading to more effective therapies for a large adolescent population, which could signal a shift towards precision medicin
Is This Trial Right for Me?
Ask your doctor if genetic testing is right for you and how it might influence your treatment plan. Participation involves regular doctor visits and potentially blood tests for genetic analysis over a 12-week period. You will receive either standard care or care guided by genetic information, with both groups closely monitored. This trial is currently recruiting participants. 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: 452 participants
Interventions
- OTHER: Pharmacogenetic-guided dosing — SSRI dosing based on Clinical Pharmacogenetics Implementation Consortium's SSRI dosing guidelines.
- OTHER: Current prescribing guidelines/recommendations — SSRI dosing based on current prescribing guidelines/recommendations
Primary Outcomes
- Number of participants with depression remission (Baseline to 12 weeks)
- Number of participants with anxiety 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 anxiety symptom severity (Baseline to 12 weeks)
- Percent change in clinician assessment of depressive and anxiety symptom severity (Baseline to 12 weeks)
Full Eligibility Criteria
Inclusion Criteria: * Age 12-17 * Depression and/or anxiety as the primary concern, confirmed by the treating physician * Intention to start a new SSRI * English fluency Exclusion Criteria: * 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
- University of Calgary, Calgary, Alberta, Canada
Frequently Asked Questions
What is clinical trial NCT06853587?
NCT06853587 is a Not Applicable INTERVENTIONAL study titled "Pharmacogenetic-Guided Antidepressant Prescribing in Adolescents With Anxiety and Depression." It is currently recruiting and is sponsored by University of Calgary. The trial targets enrollment of 452 participants.
What conditions does NCT06853587 study?
This trial investigates treatments for Anxiety and Depression. The primary condition under study is Anxiety and Depression.
What treatments are being tested in NCT06853587?
The interventions being studied include: Pharmacogenetic-guided dosing (OTHER), Current prescribing guidelines/recommendations (OTHER). SSRI dosing based on Clinical Pharmacogenetics Implementation Consortium's SSRI dosing guidelines.
What does Not Applicable mean for NCT06853587?
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 NCT06853587?
This trial is currently "Recruiting." It started on 2025-02-11. The estimated completion date is 2027-12.
Who is sponsoring NCT06853587?
NCT06853587 is sponsored by University of Calgary. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT06853587?
The trial aims to enroll 452 participants. The trial is currently recruiting and accepting new participants.
How is NCT06853587 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 NCT06853587?
The primary outcome measures are: Number of participants with depression remission (Baseline to 12 weeks); Number of participants with anxiety remission (Baseline to 12 weeks). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT06853587 being conducted?
This trial is being conducted at 1 site, including Calgary, Alberta (Canada).
Where can I find official information about NCT06853587?
The official record for NCT06853587 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06853587. This government database provides the most up-to-date and detailed information about the trial.
What is NCT06853587 testing in simple terms?
This trial tests if using genetic information can help doctors choose the best antidepressant for teenagers with anxiety and depression. It is for adolescents aged 12-17 who are experiencing depression and/or anxiety and are starting or changing an SSRI medication.
Why is this trial significant?
This trial aims to improve how antidepressants work for young people by tailoring treatment to their unique genetic makeup, addressing a gap in personalized mental healthcare.
What are the potential risks of participating in NCT06853587?
Potential side effects of antidepressants can include nausea, sleep problems, and changes in mood or behavior. There's a risk that the genetic-guided treatment may not be more effective than standard care for some individuals. As with any medication, there's a possibility of unexpected reactions or adverse drug events. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT06853587?
Ask your doctor if genetic testing is right for you and how it might influence your treatment plan. Participation involves regular doctor visits and potentially blood tests for genetic analysis over a 12-week period. You will receive either standard care or care guided by genetic information, with both groups closely monitored. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT06853587 signal from an investment perspective?
This study explores a novel approach to mental health treatment, potentially leading to more effective therapies for a large adolescent population, which could signal a shift towards precision medicin 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 antidepressant treatment guided by their genetics or by standard 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 Anxiety and Depression Trials
This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.