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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2016 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
Paul E. Croarkin, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT02286440
First received: November 5, 2014
Last updated: April 20, 2016
Last verified: April 2016
  Purpose
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 Intervention Phase
Depression
Other: AssureRx GeneSight genotyping results
Other: Treatment as usual
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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)

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Baseline to endpoint change in depression [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Quick Inventory of Depressive Symptomatology Adolescent Clinician Rated Form (QIDS-A17 CR)

  • Improvement of depressive symptoms [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Quick Inventory of Depressive Symptomatology Adolescent Self-Report (QIDS-A17 SR)

  • Improvement of depressive symptoms [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Quick Inventory of Depressive Symptomatology Adolescent Self-Report - Parent [(QIDS-A17 SR (P)

  • Improvement of depressive symptoms [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Clinical Global Impression (CGI) scale

  • Improvement of depressive symptoms [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Global Assessment Scale (CGAS)

  • Improvement of depressive symptoms [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    General Behavior Inventory Parent Version (P-GBI) (subscales mania and sleep) Short Form

  • Improvement of depressive symptoms [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Treatment adherence based on concordance vs. non-concordance of gene test results and clinical intervention


Estimated Enrollment: 276
Study Start Date: February 2015
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   13 Years to 18 Years   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02286440

Contacts
Contact: Paul Croarkin, D.O. croarkin.paul@mayo.edu

Locations
United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Paul Croarkin, D.O.       croarkin.paul@mayo.edu   
Principal Investigator: Paul E Croarkin, DO         
Mayo Clinic Not yet recruiting
Rochester, Minnesota, United States, 55905
Contact: Lorelei A. Bandel    507-255-0760    Bandel.Lorelei@mayo.edu   
Principal Investigator: Paul E. Croarkin, DO         
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Paul Croarkin, D.O. Mayo Clinic
  More Information

Responsible Party: Paul E. Croarkin, Paul E. Croarkin, D.O., M.S., Mayo Clinic
ClinicalTrials.gov Identifier: NCT02286440     History of Changes
Other Study ID Numbers: 14-005547 
Study First Received: November 5, 2014
Last Updated: April 20, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Depression
Genotyping
Pharmacokinetic
Pharmacodynamic

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on December 07, 2016