Actively Recruiting

Phase Not Applicable
Age: 12Years - 17Years
All Genders
ID06853587

Pharmacogenetic-Guided Antidepressant Prescribing in Adolescents With Anxiety and Depression

Led by University of Calgary · Updated on 2026-05-14

452

Participants Needed

1

Research Sites

13 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating pharmacogenetic-guided antidepressant prescribing for adolescents aged 12 to 17 years who have depression and/or anxiety. This trial aims to compare whether tailoring SSRI medication based on genetic metabolism profiles improves symptom remission compared to prescribing based on current guidelines. The study involves 452 participants starting or changing SSRI treatment, focusing on the impact of personalized medication choices on adolescent outcomes and healthcare use. Participants are randomly assigned to one of two groups. One group receives antidepressant dosing guided by pharmacogenetic testing of metabolism genes CYP2B6, CYP2C19, and CYP2D6 alongside clinical guidelines for fluoxetine. The other group receives dosing based solely on current prescribing guidelines without genetic information. Both participants and their doctors are blinded to the intervention type. Each participant gets a one-time prescribing report after baseline. During the 12-week treatment period, researchers assess depressive and anxiety symptom remission using validated scales (QIDS-A17 and SCARED). Additional measures include side effects, role functioning, medication adherence, health-related quality of life, and healthcare resource use at 4, 8, and 12 weeks. The study tracks changes in medication dose, agent, duration, and behavioral activation. The total participation covers these assessments and monitoring over the 12 weeks.

CONDITIONS

Brief Title

Pharmacogenetic-Guided Antidepressant Prescribing in Adolescents With Anxiety and Depression

Who Can Participate

Age: 12Years - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 12-17 years
  • Diagnosis of depression and/or anxiety confirmed by a physician
  • Planning to start a new SSRI medication
  • Ability to communicate fluently in English
Not Eligible

You will not qualify if you...

  • Diagnosis of obsessive compulsive disorder, psychosis, bipolar disorder, eating disorder, autism spectrum disorder, fetal alcohol spectrum disorder, or intellectual disability
  • History of non-response to three or more SSRI medications
  • Brain stimulation therapy started within 8 weeks before referral or planned changes during the study
  • History of liver or hematopoietic cell transplant
  • Previous genetic testing for CYP2B6, CYP2C19, or CYP2D6

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit (in-person)

Treatment

Duration - 12 weeks

Participants receive pharmacogenetic-guided or current guideline-based SSRI antidepressant therapy and are monitored for symptom remission, side effects, and medication adherence.

Visits at baseline, and at 4, 8, and 12 weeks

Trial Site Locations

Total: 1 location

1

University of Calgary

Calgary, Alberta, Canada, T2N 4N1

Actively Recruiting

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Research Team

M

Meagan Shields, BSc., MSc.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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