Genecept Assay and Adverse Effects of Antidepressants

Depression Clinical Trial

Official title: Genecept Assay and Adverse Effects of Antidepressants

Status Completed

Clinical Trial Summary

The purpose of this study is to determine whether patients who have been prescribed antidepressant medications and have experienced significant adverse effects are more likely to be poor metabolizers on the CYP450 (CYP2B6, CYP2D6, CYP2C19, CYP3A4/5+) drug metabolizing enzymes and/or homozygous for the short allele of the serotonin transporter (SLC6A4) compared to patients who took an antidepressant medication and did not experience significant adverse effects but also had minimal or no response to the medication. The target medications being studied include escitalopram, citalopram, paroxetine, fluvoxamine, venlafaxine, duloxetine, bupropion, vortioxetine, vilazodone, and levomilnacipran only.

Clinical Trial Description

Genetic variations in the CYP2B6, CYP2D6, CYP2C19, and CYP3A4/5+ drug metabolizing enzymes are responsible for metabolism of a large number of psychiatric and nonpsychiatric medications. Variations in the genes encoding for these enzymes can alter their activity resulting in unexpectedly high or low serum levels of the drug leading potentially to change in both efficacy and adverse events. The serotonin transporter protein is a presynaptic transmembrane protein responsible for serotonin reuptake. The "short" form of the serotonin transporter promoter (SLC6A4) is associated with reduced activity of the of the transporter. Patients who are homozygous for the "short" alleles of SLC6A4 may be more likely to have with poor response, slow response, and greater adverse events with serotonergic medications. The target medications being studied include escitalopram, citalopram, paroxetine, fluvoxamine, venlafaxine, duloxetine, bupropion, vortioxetine, vilazodone, and levomilnacipran only. ;

Related Conditions & MeSH terms

• Adverse Effects
• Depression

• NCT number: NCT02883660
• Study type: Observational
• Source: Thomas Jefferson University
• Status: Completed
• Phase: N/A
• Start date: February 2013
• Completion date: February 1, 2018