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

Completed · Not applicable

Conditions studied: Depression

In brief

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

Key facts

Study ID

NCT02286440

Run by

Mayo Clinic

People needed

179

Starts

2015-02-01

Expected to finish

2019-02-06

Last updated by the study team

2020-06-16

Who can join

Age: 13 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Mayo Clinic in Rochester — Rochester, Minnesota, United States
• Mayo Clinic — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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