Ignite Creation Date:
2024-05-06 @ 7:18 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05965401
Status:
RECRUITING
Last Update Posted:
2023-10-30
First Post:
2023-07-14
Brief Title:
Pharmacogenetic-Guided Antidepressant Prescribing in Adolescents
Sponsor:
University of Calgary
Organization:
University of Calgary
Study Overview
Official Title:
Pharmacogenetic-Guided Antidepressant Prescribing PGx-GAP in Adolescents
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PGx-GAP
Brief Summary:
This is a parallel arm randomized 11 controlled trial Adolescents aged 12-17 years n452 that did not respond or tolerate first-line fluoxetine therapy will be randomly allocated to receive 12-weeks of pharmacogenetic-guided antidepressant therapy experimental intervention or GLAD-PC guided prescribing control intervention
Detailed Description:
Goal To test the efficacy of pharmacogenetic-guided antidepressant prescribing for adolescents with depression
Background For an adolescent with moderate to severe depression 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 Guidelines for Adolescent Depression in Primary Care GLAD-PC However GLAD-PC does 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 GLAD-PC informed prescribing does pharmacogenetic-guided prescribing for depressed adolescents who have not responded or tolerated first-line fluoxetine therapy have superior efficacy following 12-weeks of therapy with an alternative SSRI
The Trial This is a parallel arm randomized controlled trial Adolescents aged 12-17 years n452 that did not respond or tolerate first-line fluoxetine therapy will be randomly allocated to receive pharmacogenetic-guided antidepressant therapy experimental intervention or GLAD-PC 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 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
Background For an adolescent with moderate to severe depression 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 Guidelines for Adolescent Depression in Primary Care GLAD-PC However GLAD-PC does 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 GLAD-PC informed prescribing does pharmacogenetic-guided prescribing for depressed adolescents who have not responded or tolerated first-line fluoxetine therapy have superior efficacy following 12-weeks of therapy with an alternative SSRI
The Trial This is a parallel arm randomized controlled trial Adolescents aged 12-17 years n452 that did not respond or tolerate first-line fluoxetine therapy will be randomly allocated to receive pharmacogenetic-guided antidepressant therapy experimental intervention or GLAD-PC 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 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None