NCT02883660

Genecept Assay and Adverse Effects of Antidepressants

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 74 (actual)
• Sponsor: Thomas Jefferson University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Depression
• Adverse Effects

Interventions

Type	Name	Description
GENETIC	Genocept Assay	battery of pharmacogenetic tests relevant to psychiatry

Timeline

• Start date: 2013-02-01
• Primary completion: 2017-07-01
• Completion: 2018-02-01
• First posted: 2016-08-30
• Last updated: 2018-03-16

Locations

1 site across 1 country: United States