A PK/PD Genetic Variation Treatment Algorithm Versus Treatment As Usual for Adolescent Management Of Depression

Overview

About this study

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

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

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 Criteria:

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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status	Contact
Rochester, Minn. Mayo Clinic principal investigator Paul Croarkin, D.O., M.S.	Closed for enrollment	Contact information: Jessica Ward (507) 255-0760 Ward.Jessica1@mayo.edu
Austin, Minn. Mayo Clinic principal investigator Paul Croarkin, D.O., M.S.	Closed for enrollment	Contact information: Jessica Ward (507) 255-0760 Ward.Jessica1@mayo.edu

Mayo Clinic Location

Status

Contact

Rochester, Minn.

Mayo Clinic principal investigator

Paul Croarkin, D.O., M.S.

Closed for enrollment

Contact information:

Jessica Ward

(507) 255-0760

Ward.Jessica1@mayo.edu

Austin, Minn.