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

Air Force Military Medical University of People's Liberation Army

Status and phase: Unknown; Phase 4

Conditions: Depression

Treatments: Diagnostic Test: pharmacogenomics; Diagnostic Test: pharmacogenomics & therapeutic drug monitoring; Drug: Venlafaxine

Study type: Interventional

Funder types: Other

Identifiers

NCT04207385

KY20192104-X-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with endogenous depression, with any of the following 4 symptoms: ① Interest Loss; ② Hypothymia; ③ Early awakening; ④ Serious in the morning and relieved at night; ⑤ Hysteresis or agitation of movement of Spirit; ⑥ Appetite loss; ⑦ Weight loss; ⑧ 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 4 patient groups

A group: Routine treatment group

Active Comparator group

Description:

Routine dosage of venlafaxine during the first 4 weeks.

Treatment:

Drug: Venlafaxine

B group: PGx-guided group

Experimental group

Description:

The PGx test results guide the dosage of venlafaxine during the first 4 weeks.

Treatment:

Drug: Venlafaxine

Diagnostic Test: pharmacogenomics

C group: Routine PGx-guided group

Active Comparator group

Description:

The PGx test results guide the dosage of venlafaxine between 4th and 8th weeks.

Treatment:

Drug: Venlafaxine

Diagnostic Test: pharmacogenomics

D group: The combination of PGx and TDM group

Active Comparator group

Description:

The PGx and TDM test results guide the dosage of venlafaxine between 4th and 8th weeks.

Treatment:

Diagnostic Test: pharmacogenomics & therapeutic drug monitoring

Drug: Venlafaxine

Diagnostic Test: pharmacogenomics