Depression
Conditions
Keywords
pharmacogenomics, PGx, therapeutic drug monitoring, TDM, Venlafaxine, depression
Brief 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.
Interventions
DIAGNOSTIC_TESTpharmacogenomics
pharmacogenomics
DIAGNOSTIC_TESTpharmacogenomics & therapeutic drug monitoring
pharmacogenomics & therapeutic drug monitoring
DRUGVenlafaxine
Venlafaxine hydrochloride sustained-release capsules 75mg x 14 tablets x 1 case 75-225mg/morning
Sponsors
Xijing Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Score reduction rate of Hamilton Depression Rating Scale | 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% |
Countries
China
Contacts
Primary ContactHuaning Wang
Outcome results
None listed