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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04207385
• Other study ID #: KY20192104-X-1
• Status: Recruiting
• Phase: Phase 4
• Start date: December 1, 2019
• Est. completion date: November 20, 2021

Study information

• Verified date: November 2019
• Source: Xijing Hospital
• Contact: Huaning Wang
• Phone: +86 13609161341
• Email: xskzhu[@]fmmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: November 20, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients with endogenous depression, with any of the following 4 symptoms: ? Interest Loss; ? Hypothymia; ? Early awakening; ? Serious in the morning and relieved at night; ? Hysteresis or agitation of movement of Spirit; ? Appetite loss; ? Weight loss; ? Loss of libido;

• Scores of 17 items in Hamilton Depression Scale (HAM-D17): over 17 points;

• First-episode patients or relapsed patients without taking any antidepressant drugs in the recent 3 months;

• No significant abnormalities are shown in physical examination (temperature, pulse, blood pressure, head and neck, chest and abdomen).

• No obvious abnormalities in laboratory examination (Thyroid Function).

• Informed patient consent.

Exclusion Criteria:

• Those diagnosed with mental disorders other than major depressive disorders (with the exception of combination of anxiety disorders); non-endogenous depressive disorders;

• Patients with stroke, brain tumor and other brain organic diseases;

• Patients receiving combined drugs (but there is no need to exclude patients receving drugs against sleep disorders, such as Eszopiclone, alprazolam or estazolam);

• History of drug allergy;

• Pregnant and lying-in women;

• Patients with serious suicidal tendencies.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Diagnostic Test:
• pharmacogenomics
pharmacogenomics
• 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

Locations

Country	Name	City	State
China	Xijing Hospital	Xi'an	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Score reduction rate of Hamilton Depression Rating Scale	Reduction Rate=[(total score before treatment-total score after treatment)/total score before treatment] *100%; Healed: reduction rate = 75%; Significant Effective: reduction rate=50%and <75%; ?Effective: reduction rate=25% and <50%; ?Invalid: Reduction rate < 25%	3 days