Clinical trial NCT02286440: A PK/PD Genetic Variation Treatment Algorithm Versus Treatment As Usual for Adolescent Management Of Depression
Official title: A Pharmacokinetic/Pharmacodynamic Genetic Variation Treatment Algorithm Versus Treatment As Usual for Adolescent Management Of Depression (Abbreviation Assurex AMOD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Depression
Genotyping
Pharmacokinetic
Pharmacodynamic
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2014-11-07
Enrollment: 179
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Baseline to endpoint change in depression
timeFrame: 8 weeks
Secondary outcomes:
measure: Improvement of depressive symptoms
timeFrame: 8 weeks
measure: Improvement of depressive symptoms
timeFrame: 8 weeks
measure: Improvement of depressive symptoms
timeFrame: 8 weeks
measure: Improvement of depressive symptoms
timeFrame: 8 weeks
measure: Improvement of depressive symptoms
timeFrame: 8 weeks
measure: Improvement of depressive symptoms
timeFrame: 8 weeks
measure: Improvement of depressive symptoms
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Paul Croarkin, D.O.
role: PRINCIPAL_INVESTIGATOR
References:
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.