Accurate Clinical Study of Medication in Patients With Depression Via Pharmacogenomics (PGx) and Therapeutic Drug Monitoring (TDM) of Venlafaxine
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Score reduction rate of Hamilton Depression Rating Scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
B group: PGx-guided group
The PGx test results guide the dosage of venlafaxine during the first 4 weeks.
干预措施: Venlafaxine (Drug)
A group: Routine treatment group
Routine dosage of venlafaxine during the first 4 weeks.
干预措施: Venlafaxine (Drug)
B group: PGx-guided group
The PGx test results guide the dosage of venlafaxine during the first 4 weeks.
干预措施: pharmacogenomics (Diagnostic Test)
C group: Routine PGx-guided group
The PGx test results guide the dosage of venlafaxine between 4th and 8th weeks.
干预措施: pharmacogenomics (Diagnostic Test)
C group: Routine PGx-guided group
The PGx test results guide the dosage of venlafaxine between 4th and 8th weeks.
干预措施: Venlafaxine (Drug)
D group: The combination of PGx and TDM group
The PGx and TDM test results guide the dosage of venlafaxine between 4th and 8th weeks.
干预措施: pharmacogenomics (Diagnostic Test)
D group: The combination of PGx and TDM group
The PGx and TDM test results guide the dosage of venlafaxine between 4th and 8th weeks.
干预措施: pharmacogenomics & therapeutic drug monitoring (Diagnostic Test)
D group: The combination of PGx and TDM group
The PGx and TDM test results guide the dosage of venlafaxine between 4th and 8th weeks.
干预措施: Venlafaxine (Drug)
结局指标
主要结局
Score reduction rate of Hamilton Depression Rating Scale
时间窗: 3 days
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％; ③Effective: reduction rate≥25％ and \<50％; ④Invalid: Reduction rate \< 25%
次要结局
未报告次要终点