Recruiting

Antidepressant Prescribing

Sponsor:

University of Calgary

Code:

NCT06853587

Conditions

Anxiety and Depression

Eligibility Criteria

Sex: All

Age: 12 - 17

Healthy Volunteers: Not accepted

Interventions

Pharmacogenetic-guided dosing

Current prescribing guidelines/recommendations

Study Details

Brief 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 intervention) or current prescribing guidelines/recommendations guided therapy (control intervention).

Conditions

Anxiety and Depression

Study ID

NCT06853587

Start date

Feb 11, 2025

Status verified date

Jun, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 17

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

228 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Experimental: Pharmacogenetic (PGx)-Guided

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.

active comparator: Current Prescribing Guidelines/Recommendations

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.

Interventions

Pharmacogenetic-guided dosing

SSRI dosing based on Clinical Pharmacogenetics Implementation Consortium's SSRI dosing guidelines.

Current prescribing guidelines/recommendations

SSRI dosing based on current prescribing guidelines/recommendations

Primary outcome measure

  • Number of participants with depression remission [ Time Frame: Baseline to 12 weeks ]
  • Number of participants with anxiety remission [ Time Frame: Baseline to 12 weeks ]

Central Contacts and Locations

Central contacts

Madison Heintz, MSW

587-223-3154gap@ucalgary.ca

Locations

University of Calgary

Recruiting

Calgary, Alberta, Canada, T2N 4N1

Contacts

Meagan Shields, BSc., MSc.

403-210-6353gap@ucalgary.ca

Principal Investigator:

Chad Bousman, PhD

More Information

Sponsor

University of Calgary

Last update posted

Jun 22, 2026

Last verified

Jun, 2026

Keywords

  • depression
  • anxiety
  • adolescence
  • SSRI
  • antidepressant
  • pharmacogenetics

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Calgary on 2026-06-22.