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

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.

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.