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

Sponsor

Mayo Clinic (Other)

Overall Status

Completed

CT.gov ID

NCT02286440

Collaborator

(none)

179

Enrollment

Locations

Arms

48.2

Duration (Months)

89.5

Patients Per Site

1.9

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Depression	Other: AssureRx GeneSight genotyping results Other: Treatment as usual	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

179 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A Pharmacokinetic/Pharmacodynamic Genetic Variation Treatment Algorithm Versus Treatment As Usual for Adolescent Management Of Depression (Abbreviation Assurex AMOD)

Study Start Date :

Feb 1, 2015

Actual Primary Completion Date :

Feb 6, 2019

Actual Study Completion Date :

Feb 6, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: GeneSight guided treatment GeneSight guided group will have their research psychiatrist make treatment recommendations based on test results	Other: AssureRx GeneSight genotyping results
Active Comparator: Treatment as usual group Treatment as usual group will have treatment recommendations based on clinical judgment	Other: Treatment as usual

Arm

Intervention/Treatment

Experimental: GeneSight guided treatment

GeneSight guided group will have their research psychiatrist make treatment recommendations based on test results

Other: AssureRx GeneSight genotyping results

Active Comparator: Treatment as usual group

Treatment as usual group will have treatment recommendations based on clinical judgment

Other: Treatment as usual

Outcome Measures

Primary Outcome Measures

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

Improvement of depressive symptoms [8 weeks]
Quick Inventory of Depressive Symptomatology Adolescent Clinician Rated Form (QIDS-A17 CR)
Improvement of depressive symptoms [8 weeks]
Quick Inventory of Depressive Symptomatology Adolescent Self-Report (QIDS-A17 SR)
Improvement of depressive symptoms [8 weeks]
Quick Inventory of Depressive Symptomatology Adolescent Self-Report - Parent [(QIDS-A17 SR (P)
Improvement of depressive symptoms [8 weeks]
Clinical Global Impression (CGI) scale
Improvement of depressive symptoms [8 weeks]
Global Assessment Scale (CGAS)
Improvement of depressive symptoms [8 weeks]
General Behavior Inventory Parent Version (P-GBI) (subscales mania and sleep) Short Form
Improvement of depressive symptoms [8 weeks]
Treatment adherence based on concordance vs. non-concordance of gene test results and clinical intervention

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years to 18 Years

Sexes Eligible for Study:

All

Accepts 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.