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

Mayo Clinic

Status

Completed

Conditions

Depression

Treatments

Other: AssureRx GeneSight genotyping results

Other: Treatment as usual

Study type

Interventional

Funder types

Other

Identifiers

NCT02286440

14-005547

Details and patient eligibility

About

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

Full 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 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.

Enrollment

179 patients

Sex

All

Ages

13 to 18 years old

Volunteers

No Healthy Volunteers

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.