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).
Age 12-17
Depression and/or anxiety as the primary concern, confirmed by the treating physician
Intention to start a new SSRI
English fluency
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
Parallel
Pharmacogenetic-guided dosing
Other interventionSSRI dosing based on Clinical Pharmacogenetics Implementation Consortium's SSRI dosing guidelines.
Current prescribing guidelines/recommendations
Other interventionSSRI dosing based on current prescribing guidelines/recommendations
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.
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.
Number of participants with side effects and adverse drug reactions
Frequency, Intensity, Burden of Side Effects Rating (FIBSER) scale. Total scores range from 0-6 (3 items); cut-points are used to indicate moderate (score of 3) or severe (score of 5) adverse drug reaction/side effect interference with activities.
Percent change in role functioning
WHO Disability Assessment Schedule. Scores range from 0 to 48, with higher scores indicative of worse role functioning.
Percent change in depressive symptom severity
Quick Inventory of Depressive Symptomatology - Adolescent - 17-item (QIDS-A17). Scores range from 0-27, with higher scores indicative of more severe depression.
Percent change in anxiety symptom severity
Screen for Child Anxiety Related Disorders (SCARED) total score \< 25. Scores range from 0-82, with higher scores indicative of more severe anxiety.
Minimally clinically important differences
Participant-reported, Global Rating of Change Scale (GRCS) (11-point Likert scale ranging from +5 to -5) to indicate the degree to which symptoms and role functioning changed for the better, for the worse, or no change was experienced.
Intervention fidelity
Physician-reported, two questions on use of recommendations in the dosing report.
Blinding fidelity
Physician-reported, 1-item survey about the perceived allocation of each of their participating patients; response options are 'PGx-guided prescribing', 'don't know' or 'current prescribing guidelines/recommendations'
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