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

Mayo Clinic179 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

179

Conditions

Depression

Interventions

AssureRx GeneSight genotyping resultsOTHER

Treatment as usualOTHER

Eligibility

Sex: ALLMin age: 13 YearsMax age: 18 Years

Medical Language ↔ Plain English

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.

Locations (2)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Mayo Clinic

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

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).

Time frame: 8 weeks