NCT05965401

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 will be randomly allocated to receive 12-weeks of pharmacogenetic-guided antidepressant therapy (experimental intervention) or GLAD-PC guided prescribing (control intervention).

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 14, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 28, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

October 25, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 2, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 2, 2025

Completed
Last Updated

May 20, 2025

Status Verified

May 1, 2025

Enrollment Period

1.5 years

First QC Date

July 14, 2023

Last Update Submit

May 14, 2025

Conditions

Depression in Adolescence

Keywords

DepressionAdolescenceSSRIAntidepressantPharmacogenetics

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (9)

  • 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

  • +4 more secondary outcomes

Other Outcomes (3)

  • Minimally clinically important differences

    12 weeks

  • Intervention fidelity

    12 weeks

  • Blinding fidelity

    12 weeks

Study Arms (2)

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 GLAD-PC dosing guidelines for fluoxetine as there are no pharmacogenetic guidelines for this medication.

Other: Pharmacogenetic-guided dosing

Guidelines for Adolescent Depression in Primary Care (GLAD-PC)-Guided

ACTIVE COMPARATOR

Participants and their physician will receive a one-time prescribing report after completing baseline for selective serotonin reuptake inhibitors based on GLAD-PC dosing guidelines.

Other: GLAD-PC guided dosing

Interventions

Pharmacogenetic-guided dosingOTHER

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

Pharmacogenetic (PGx)-Guided
GLAD-PC guided dosingOTHER

SSRI dosing based on GLAD-PC clinical practice guidelines

Guidelines for Adolescent Depression in Primary Care (GLAD-PC)-Guided

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Calgary

Calgary, Alberta, T2N 4N1, Canada

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Chad Bousman, PhD

    University of Calgary

    PRINCIPAL INVESTIGATOR

  • Amanda Newton, PhD

    University of Alberta

    PRINCIPAL INVESTIGATOR

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
Model Details: This is a parallel arm randomized controlled trial.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 14, 2023

First Posted

July 28, 2023

Study Start

October 25, 2023

Primary Completion

May 2, 2025

Study Completion

May 2, 2025

Last Updated

May 20, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will share

Anonymized, individual participant PGx-GAP data will be shared using a controlled-access model. Under this model, the data will be released to a researcher if access criteria are met. All requests for data sharing should be made to the Co-Principal Investigators who will be responsible for reviewing and granting requests. Requestors should provide a research proposal for review. In the event that a data sharing request is declined, reasons will be provided to the requestor. If the data sharing request is granted, a data-sharing agreement will be initiated by the Co-Principal Investigators alongside the University of Calgary (lead institution). This agreement will include information on the individual data to be shared; if other documents will be available (e.g., statistical codes, data dictionary), when the data will be available and for how long, and how data access will be provided (e.g., file transfer).

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)