Pharmacogenetic-Guided Antidepressant Prescribing in Adolescents With Anxiety and Depression

NCT06853587 | Recruiting DMC

• 1 other identifier: 2025-23-0532
• Study Type: interventional
• Target: 452
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Anxiety and Depression

Keywords

depression; anxiety; adolescence; SSRI; antidepressant; pharmacogenetics

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline to 12 weeks

• Number of participants with anxiety remission

  Screen for Child Anxiety Related Disorders (SCARED) total score \< 25. Scores range from 0-82, with higher scores indicative of more severe anxiety.

  Baseline to 12 weeks

Secondary Outcomes (15)

• 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

Other Outcomes (3)

• Minimally clinically important differences

  12 weeks

• Intervention fidelity

  12 weeks

• Blinding fidelity

  12 weeks

Study Arms (2)

Experimental: 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 clinical practice guidelines for fluoxetine as there are no pharmacogenetic guidelines for this medication.

Other: Pharmacogenetic-guided dosing

Current Prescribing Guidelines/Recommendations

ACTIVE COMPARATOR

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.

Other: Current prescribing guidelines/recommendations

Interventions

Pharmacogenetic-guided dosing OTHER

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

Experimental: Pharmacogenetic (PGx)-Guided

Current prescribing guidelines/recommendations OTHER

SSRI dosing based on current prescribing guidelines/recommendations

Current Prescribing Guidelines/Recommendations

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age 12-17
• Depression and/or anxiety as the primary concern, confirmed by the treating physician
• Intention to start a new SSRI
• English fluency

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

University of Calgary

Calgary, Alberta, T2N 4N1, Canada

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Chad Bousman, PhD

  University of Calgary

  PRINCIPAL INVESTIGATOR

• Amanda Newton, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laina McAusland, MSc

CONTACT

403-210-6353; gap@ucalgary.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, their prescribing physician, and the investigator will all be blinded to study arm. The study coordinator will be the only one unblinded to study arm allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This is a parallel arm randomized controlled trial.

Study Record Dates

• First Submitted: February 20, 2025
• First Posted: March 3, 2025
• Study Start: February 11, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 27, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Access Criteria: 1. The requestor is affiliated with an academic institution as an independent investigator or trainee of an independent investigator; 2. The proposed research question(s) and hypothesis(es) are specific, measurable, and achievable; 3. The proposed research project will be governed/overseen by a local legal/regulatory body; 4. The proposed research project poses no risk of invasion of privacy or breaches of confidentiality for trial participants; 5. A member of the proposed research team has sufficient statistical skills to carry out the proposed analytic plan; 6. The requestor has sufficient financial and/or human resources to see the proposed research project to completion; 7. The proposed research question(s) and hypothesis(es) do not conflict with active or planned studies of the Co-Principal Investigators.

Locations

CA (1)