Pharmacogenetic-Guided Antidepressant Prescribing in Adolescents With Anxiety and Depression

Goal: To test the efficacy of pharmacogenetic-guided antidepressant prescribing for adolescents with depression.

Background: For an adolescent with depression and anxiety, antidepressant medication is prescribed, often in combination with psychotherapy. The class of antidepressants recommended for use is selective serotonin reuptake inhibitors (SSRIs) with fluoxetine recommended as the first-line medication, and four other SSRIs recommended for consideration (sertraline, citalopram, escitalopram, fluvoxamine) if the adolescent does not respond or tolerate fluoxetine. For most adolescents, medication prescribing, and monitoring will be managed by a primary care physician or community pediatrician rather than by a mental health care provider, and guidelines exist to support this management. However, current prescribing guidelines/recommendations do not account for SSRI metabolism phenotypes that could change whether the SSRI selected is efficacious or tolerated. Our team of researchers, clinician scientists, patient partners, and primary care providers has designed a trial to test the impact of accounting for metabolism phenotypes, through pharmacogenetic-guided antidepressant prescribing, on adolescent outcomes, experiences, and health care utilization.

Principal Question: Compared to current prescribing guideline/recommendation informed prescribing, does pharmacogenetic-guided prescribing for adolescents with depression and/or anxiety have superior efficacy following 12-weeks of therapy with a SSRI?

The Trial: This is a parallel arm randomized controlled trial. Adolescents aged 12-17 years (n=228) who are starting or changing a SSRI for depression and/or anxiety will be randomly allocated to receive pharmacogenetic-guided antidepressant therapy (experimental intervention) or current prescribing guideline/recommendation guided prescribing (control intervention). Participants and prescribing physicians will be blinded to which intervention was received. The primary outcome is depressive symptom remission at 12 weeks measured using the Quick Inventory of Depressive Symptomatology - Adolescent (17-item) (QIDS-A17) and anxiety symptom remission at 12 weeks measures using the Screen for Child Anxiety Related Disorders (SCARED). Secondary outcomes include side effects, role functioning, medication adherence, and health-related quality of life measured 4-, 8-, and 12-weeks after intervention initiation as well as cost-effectiveness.

• Number of participants with side effects and adverse drug reactions [Срок оценки: Baseline to 12 weeks]
• Percent change in role functioning [Срок оценки: Baseline to 12 weeks]
• Percent change in depressive symptom severity [Срок оценки: Baseline to 12 weeks]
• Percent change in anxiety symptom severity [Срок оценки: Baseline to 12 weeks]
• Percent change in clinician assessment of depressive and anxiety symptom severity [Срок оценки: Baseline to 12 weeks]
• Change in self-report health care resource use [Срок оценки: Baseline to 12 weeks]
• Change in healthcare utilization - physician visits [Срок оценки: Baseline to 12 weeks]
• Change in health care utilization - emergency department visits [Срок оценки: Baseline to 12 weeks]
• Change in health care utilization - hospitalizations [Срок оценки: Baseline to 12 weeks]
• Change in prescribed medication dose [Срок оценки: Baseline to 12 weeks]
• Change in prescribed agent [Срок оценки: Baseline to 12 weeks]
• Change in prescribed medication duration [Срок оценки: Baseline to 12 weeks]