NCT04207385

Accurate Clinical Study of Medication in Patients With Depression Via Pharmacogenomics (PGx) and Therapeutic Drug Monitoring (TDM) of Venlafaxine

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Xijing Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates the efficacy of PGx-guided medication in patients with depression treated with Venlafaxine and the efficacy of the combination of PGx and TDM in patients with depression treated with Venlafaxine. Half of participants will receive PGx-guided treatment, while the other half will receive routine treatment. After the 8th week, the PGx-guided treatment group would be randomly divided into two groups. Of which, half of participants will receive the combination of PGx and TDM, and the other half will receive PGx -guided medication only.

Detailed description

The current clinical medication is based on "Trial and Error", while the traditional medication is mainly based on experience. The study mainly optimizes the treatment path from two perspectives: to help clinicians select drugs accurately through the detection of PGx; to help clinicians monitor the whole process of drug use through TDM and adjust the dosage in time to achieve better treatment. PGx tests take the information of metabolic, transporting and target genetic factors into account comprehensively. Furthermore, clinical effects depend on blood concentration rather than dose concentration. TDM aims to monitor blood concentration, which is related to drug efficacy and toxicity. Venlafaxine is an antidepressant drugs of the 5-hydroxytryptamine selective seratonin re-uptake inhibitors (SSRIs), which has been approved by FDA for the treatment of depressive disorders, depressive disorders with anxiety symptoms, generalized anxiety disorders and social anxiety disorders since 1994.

Conditions

• Depression

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	pharmacogenomics	pharmacogenomics
DIAGNOSTIC_TEST	pharmacogenomics & therapeutic drug monitoring	pharmacogenomics \& therapeutic drug monitoring
DRUG	Venlafaxine	Venlafaxine hydrochloride sustained-release capsules 75mg x 14 tablets x 1 case 75-225mg/morning

Timeline

• Start date: 2019-12-01
• Primary completion: 2021-08-31
• Completion: 2021-11-20
• First posted: 2019-12-20
• Last updated: 2019-12-20

Locations

1 site across 1 country: China