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

Not Applicable

Completed

• Conditions: Depression
• Interventions: Other: AssureRx GeneSight genotyping results; Other: Treatment as usual

• Registration Number: NCT02286440
• Lead Sponsor: Mayo Clinic

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 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

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 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 Timeline

• Study First Submitted: 2014-11-05
• Study First Submitted QC: 2014-11-05
• Study First Posted: 2014-11-07
• Study Start: 2015-02
• Primary Completion: 2019-02-06
• Study Completion: 2019-02-06
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-11
• Last Update Posted: 2020-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 179

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
GeneSight guided treatment	AssureRx GeneSight genotyping results	GeneSight guided group will have their research psychiatrist make treatment recommendations based on test results
Treatment as usual group	Treatment as usual	Treatment as usual group will have treatment recommendations based on clinical judgment

Primary Outcome Measures

Name	Time	Method
Baseline to endpoint change in depression	8 weeks	The primary outcome measure is the baseline to endpoint change in the Children's Depression Rating Scale, Revised (CDRS-R).

Secondary Outcome Measures

Name	Time	Method
Improvement of depressive symptoms	8 weeks	Treatment adherence based on concordance vs. non-concordance of gene test results and clinical intervention

Trial Locations

Locations (2)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States