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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A group: Routine treatment group | Active Comparator | Routine dosage of venlafaxine during the first 4 weeks. |
|
| B group: PGx-guided group | Experimental | The PGx test results guide the dosage of venlafaxine during the first 4 weeks. |
|
| C group: Routine PGx-guided group | Active Comparator | The PGx test results guide the dosage of venlafaxine between 4th and 8th weeks. |
|
| D group: The combination of PGx and TDM group | Active Comparator | The PGx and TDM test results guide the dosage of venlafaxine between 4th and 8th weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pharmacogenomics | Diagnostic Test | pharmacogenomics |
|
| Measure | Description | Time Frame |
|---|---|---|
| Score reduction rate of Hamilton Depression Rating Scale | Reduction Rate=[(total score before treatment-total score after treatment)/total score before treatment] *100%
| 3 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huaning Wang | Contact | +86 13609161341 | xskzhu@fmmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Huaning Wang | Deputy Chief Physician | Study Chair |
| Ping Zhou | Attending Physician | Principal Investigator |
| Yihuan Chen |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xijing Hospital | Recruiting | Xi’an | Shanxi | 710032 | China |
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| pharmacogenomics & therapeutic drug monitoring | Diagnostic Test | pharmacogenomics & therapeutic drug monitoring |
|
| Venlafaxine | Drug | Venlafaxine hydrochloride sustained-release capsules 75mg x 14 tablets x 1 case 75-225mg/morning |
|
| Attending Physician |
| Principal Investigator |
| Huizhen Lu | Resident Physician | Principal Investigator |
| Qinghong Yan | Nurse | Principal Investigator |
| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000071185 | Pharmacogenomic Testing |
| D016903 | Drug Monitoring |
| D000069470 | Venlafaxine Hydrochloride |
| ID | Term |
|---|---|
| D005820 | Genetic Testing |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
| D005821 | Genetic Techniques |
| D033142 | Genetic Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D003954 | Diagnostic Services |
| D011314 | Preventive Health Services |
| D008991 | Monitoring, Physiologic |
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000588 | Amines |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D008055 | Lipids |
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