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

Primary Purpose

Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AssureRx GeneSight genotyping results
Treatment as usual
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Depression, Genotyping, Pharmacokinetic, Pharmacodynamic

Eligibility Criteria

13 Years - 18 Years (Child, Adult)All SexesDoes not accept 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.

Sites / Locations

  • Mayo Clinic in Rochester
  • Mayo Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

GeneSight guided treatment

Treatment as usual group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Full Information

First Posted
November 5, 2014
Last Updated
June 11, 2020
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT02286440
Brief Title
A PK/PD Genetic Variation Treatment Algorithm Versus Treatment As Usual for Adolescent Management Of Depression
Acronym
AMOD
Official Title
A Pharmacokinetic/Pharmacodynamic Genetic Variation Treatment Algorithm Versus Treatment As Usual for Adolescent Management Of Depression (Abbreviation Assurex AMOD)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
February 6, 2019 (Actual)
Study Completion Date
February 6, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Data Monitoring Committee
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Depression, Genotyping, Pharmacokinetic, Pharmacodynamic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
179 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GeneSight guided treatment
Arm Type
Experimental
Arm Description
GeneSight guided group will have their research psychiatrist make treatment recommendations based on test results
Arm Title
Treatment as usual group
Arm Type
Active Comparator
Arm Description
Treatment as usual group will have treatment recommendations based on clinical judgment
Intervention Type
Other
Intervention Name(s)
AssureRx GeneSight genotyping results
Intervention Type
Other
Intervention Name(s)
Treatment as usual
Primary Outcome Measure Information:
Title
Baseline to endpoint change in depression
Description
The primary outcome measure is the baseline to endpoint change in the Children's Depression Rating Scale, Revised (CDRS-R).
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Improvement of depressive symptoms
Description
Quick Inventory of Depressive Symptomatology Adolescent Clinician Rated Form (QIDS-A17 CR)
Time Frame
8 weeks
Title
Improvement of depressive symptoms
Description
Quick Inventory of Depressive Symptomatology Adolescent Self-Report (QIDS-A17 SR)
Time Frame
8 weeks
Title
Improvement of depressive symptoms
Description
Quick Inventory of Depressive Symptomatology Adolescent Self-Report - Parent [(QIDS-A17 SR (P)
Time Frame
8 weeks
Title
Improvement of depressive symptoms
Description
Clinical Global Impression (CGI) scale
Time Frame
8 weeks
Title
Improvement of depressive symptoms
Description
Global Assessment Scale (CGAS)
Time Frame
8 weeks
Title
Improvement of depressive symptoms
Description
General Behavior Inventory Parent Version (P-GBI) (subscales mania and sleep) Short Form
Time Frame
8 weeks
Title
Improvement of depressive symptoms
Description
Treatment adherence based on concordance vs. non-concordance of gene test results and clinical intervention
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Croarkin, D.O.
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34099307
Citation
Vande Voort JL, Orth SS, Shekunov J, Romanowicz M, Geske JR, Ward JA, Leibman NI, Frye MA, Croarkin PE. A Randomized Controlled Trial of Combinatorial Pharmacogenetics Testing in Adolescent Depression. J Am Acad Child Adolesc Psychiatry. 2022 Jan;61(1):46-55. doi: 10.1016/j.jaac.2021.03.011. Epub 2021 Jun 5.
Results Reference
derived
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

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

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