A PK/PD Genetic Variation Treatment Algorithm Versus Treatment As Usual for Adolescent Management Of Depression
AMOD
A Pharmacokinetic/Pharmacodynamic Genetic Variation Treatment Algorithm Versus Treatment As Usual for Adolescent Management Of Depression (Abbreviation Assurex AMOD)
1 other identifier
interventional
179
1 country
2
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable depression
Started Feb 2015
Longer than P75 for not_applicable depression
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 5, 2014
CompletedFirst Posted
Study publicly available on registry
November 7, 2014
CompletedStudy Start
First participant enrolled
February 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 6, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 6, 2019
CompletedJune 16, 2020
June 1, 2020
4 years
November 5, 2014
June 11, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
8 weeks
Secondary Outcomes (7)
Improvement of depressive symptoms
8 weeks
Improvement of depressive symptoms
8 weeks
Improvement of depressive symptoms
8 weeks
Improvement of depressive symptoms
8 weeks
Improvement of depressive symptoms
8 weeks
- +2 more secondary outcomes
Study Arms (2)
GeneSight guided treatment
EXPERIMENTALGeneSight guided group will have their research psychiatrist make treatment recommendations based on test results
Treatment as usual group
ACTIVE COMPARATORTreatment as usual group will have treatment recommendations based on clinical judgment
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (2)
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Related Publications (2)
Nooraeen S, Croarkin PE, Geske JR, Shekunov J, Orth SS, Romanowicz M, Frye MA, Vande Voort JL. High Probability of Gene-Drug Interactions Associated with Medication Side Effects in Adolescent Depression: Results from a Randomized Controlled Trial of Pharmacogenetic Testing. J Child Adolesc Psychopharmacol. 2024 Feb;34(1):28-33. doi: 10.1089/cap.2023.0043.
PMID: 38377526DERIVEDVande 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.
PMID: 34099307DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paul Croarkin, D.O.
Mayo Clinic
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Paul E. Croarkin, D.O., M.S.
Study Record Dates
First Submitted
November 5, 2014
First Posted
November 7, 2014
Study Start
February 1, 2015
Primary Completion
February 6, 2019
Study Completion
February 6, 2019
Last Updated
June 16, 2020
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will not share