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

• Status: Recruiting
• Trial end date: 2021-11-20
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Xijing Hospital
• Treatments: Venlafaxine Hydrochloride

Criteria

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.