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The overall goal of this investigator-initiated trial is to evaluate the impact of platform algorithm products designed to rapidly identify pharmacokinetic (PK) and/or pharmacodynamic (PD) genomic variation on treatment outcome of depression in adolescents. This new technology may have the potential to optimize treatment selection by improving response, minimizing unfavorable adverse events / side effects and increasing treatment adherence
Treatment seeking adolescent patients with a moderate to severe major depressive episode defined as a 40 or greater on Childhood Depression Rating Scale-Revised (CDRS-R) will be invited to participate in this study evaluating the GeneSight® platform. This new technology can rapidly assess PK and PD genetic variation that can potentially impact antidepressant, anti-psychotic, and stimulant treatment selection. These patients will have GeneSight® testing and will be randomized to one of two groups. In Group 1 (n=138), GeneSight® testing results will be available to the patient's treating clinician prior to treatment selection. In Group 2 (n=138), testing results will not be available to the patient's research treating clinician. However, all testing results will be made available to all participants and clinicians after the 8-week trial (upon completion of blinded assessments at week 8). The patients and the clinical raters will be blinded to group assignment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GeneSight guided treatment | Experimental | GeneSight guided group will have their research psychiatrist make treatment recommendations based on test results |
|
| Treatment as usual group | Active Comparator | Treatment as usual group will have treatment recommendations based on clinical judgment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AssureRx GeneSight genotyping results | Other |
| ||
| Treatment as usual |
| Measure | Description | Time Frame |
|---|---|---|
| Baseline to endpoint change in depression | The primary outcome measure is the baseline to endpoint change in the Children's Depression Rating Scale, Revised (CDRS-R). | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of depressive symptoms | Quick Inventory of Depressive Symptomatology Adolescent Clinician Rated Form (QIDS-A17 CR) | 8 weeks |
| Improvement of depressive symptoms | Quick Inventory of Depressive Symptomatology Adolescent Self-Report (QIDS-A17 SR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Croarkin, D.O. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States | ||
| Mayo Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38377526 | Derived | Nooraeen S, Croarkin PE, Geske JR, Shekunov J, Orth SS, Romanowicz M, Frye MA, Vande Voort JL. High Probability of Gene-Drug Interactions Associated with Medication Side Effects in Adolescent Depression: Results from a Randomized Controlled Trial of Pharmacogenetic Testing. J Child Adolesc Psychopharmacol. 2024 Feb;34(1):28-33. doi: 10.1089/cap.2023.0043. | |
| 34099307 |
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Other |
|
| 8 weeks |
| Improvement of depressive symptoms | Quick Inventory of Depressive Symptomatology Adolescent Self-Report - Parent [(QIDS-A17 SR (P)](streamdown:incomplete-link) | 8 weeks |
| Improvement of depressive symptoms | Clinical Global Impression (CGI) scale | 8 weeks |
| Improvement of depressive symptoms | Global Assessment Scale (CGAS) | 8 weeks |
| Improvement of depressive symptoms | General Behavior Inventory Parent Version (P-GBI) (subscales mania and sleep) Short Form | 8 weeks |
| Improvement of depressive symptoms | Treatment adherence based on concordance vs. non-concordance of gene test results and clinical intervention | 8 weeks |
| Rochester |
| Minnesota |
| 55905 |
| United States |
| Vande Voort JL, Orth SS, Shekunov J, Romanowicz M, Geske JR, Ward JA, Leibman NI, Frye MA, Croarkin PE. A Randomized Controlled Trial of Combinatorial Pharmacogenetics Testing in Adolescent Depression. J Am Acad Child Adolesc Psychiatry. 2022 Jan;61(1):46-55. doi: 10.1016/j.jaac.2021.03.011. Epub 2021 Jun 5. |