Status:
COMPLETED
A PK/PD Genetic Variation Treatment Algorithm Versus Treatment As Usual for Adolescent Management Of Depression
Lead Sponsor:
Mayo Clinic
Conditions:
Depression
Eligibility:
All Genders
13-18 years
Phase:
NA
Brief Summary
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 var...
Detailed Description
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...
Eligibility Criteria
Inclusion
- Age 13-18, male or female, any race/ethnicity
- Treating clinician, patient, and family feel that pharmacotherapy is indicated as part of a comprehensive treatment plan.
- Major depressive episode diagnosis or bipolar disorder based on KSADS-PL semi-structured psychiatric interview with a severity criteria-40 or greater on Childhood Depression Rating Scale-Revised (CDRS-R)
- Ability to provide informed consent
Exclusion
- Inability to speak English
- Inability or lack of willingness to provide informed consent and assent.
- Axis I diagnoses: Autism Spectrum Disorder, Anorexia Nervosa, Schizophreniform, and Schizophrenia.
- Psychotropic medication change (including dosage) between screening \& randomization visits.
- Patients who meet DSM 5 criteria for any significant current substance use disorder other than nicotine, caffeine, or cannabis. Must have at least early, partial or full, remission X 3 months
- Serious suicidal risk and/or in need of immediate hospitalization as judged by the investigator.
- Significant unstable medical condition.
- Anticipated inability to attend scheduled study visits.
- Patients who in the judgment of the Investigator may be unreliable or uncooperative with the evaluation procedure outlined in this protocol.
- Cytochrome (CYP) \& serotonin transporter genomic testing within 5 years.
Key Trial Info
Start Date :
February 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 6 2019
Estimated Enrollment :
179 Patients enrolled
Trial Details
Trial ID
NCT02286440
Start Date
February 1 2015
End Date
February 6 2019
Last Update
June 16 2020
Active Locations (2)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
2
Mayo Clinic
Rochester, Minnesota, United States, 55905