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

June 11, 2020 updated by: Paul E. Croarkin, Mayo Clinic

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

179

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Paul Croarkin, D.O., Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Actual)

February 6, 2019

Study Completion (Actual)

February 6, 2019

Study Registration Dates

First Submitted

November 5, 2014

First Submitted That Met QC Criteria

November 5, 2014

First Posted (Estimate)

November 7, 2014

Study Record Updates

Last Update Posted (Actual)

June 16, 2020

Last Update Submitted That Met QC Criteria

June 11, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-005547

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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