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

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ClinicalTrials.gov Identifier: NCT02286440
Recruitment Status : Active, not recruiting
First Posted : November 7, 2014
Last Update Posted : September 28, 2018
Sponsor:
Information provided by (Responsible Party):
Paul E. Croarkin, 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

Condition or disease Intervention/treatment Phase
Depression Other: AssureRx GeneSight genotyping results Other: Treatment as usual Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 276 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 : February 2015
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. Improvement of depressive symptoms [ Time Frame: 8 weeks ]
    Quick Inventory of Depressive Symptomatology Adolescent Clinician Rated Form (QIDS-A17 CR)

  2. Improvement of depressive symptoms [ Time Frame: 8 weeks ]
    Quick Inventory of Depressive Symptomatology Adolescent Self-Report (QIDS-A17 SR)

  3. Improvement of depressive symptoms [ Time Frame: 8 weeks ]
    Quick Inventory of Depressive Symptomatology Adolescent Self-Report - Parent [(QIDS-A17 SR (P)

  4. Improvement of depressive symptoms [ Time Frame: 8 weeks ]
    Clinical Global Impression (CGI) scale

  5. Improvement of depressive symptoms [ Time Frame: 8 weeks ]
    Global Assessment Scale (CGAS)

  6. Improvement of depressive symptoms [ Time Frame: 8 weeks ]
    General Behavior Inventory Parent Version (P-GBI) (subscales mania and sleep) Short Form

  7. Improvement of depressive symptoms [ Time Frame: 8 weeks ]
    Treatment adherence based on concordance vs. non-concordance of gene test results and clinical intervention



Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02286440


Locations
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United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Paul Croarkin, D.O. Mayo Clinic

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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
First Posted: November 7, 2014    Key Record Dates
Last Update Posted: September 28, 2018
Last Verified: September 2018

Keywords provided by Paul E. Croarkin, Mayo Clinic:
Depression
Genotyping
Pharmacokinetic
Pharmacodynamic

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