A Single-center Randomized Controlled Study on the Effect of Pharmacogenomics Trial on Clinical Efficacy in Patients With Depression

Zhejiang University

Status: Completed

Conditions: Pharmacogenomic Drug Interaction; Depressive Disorder

Treatments: Diagnostic Test: pharmacogenomic testing

Study type: Interventional

Funder types: Other

Identifiers

NCT05959187

2023-07-12

Details and patient eligibility

About

The purpose of this clinical trial is to explore the efficacy of drug therapy under the guidance of pharmacogenomics test in the treatment of patients with depression. The main questions to be answered in this study are:

1. Whether the drug treatment regimen under the guidance of pharmacogenomics test is beneficial to the rehabilitation of patients with depression.
2. Pharmacogenomics tests whether it can reduce adverse drug reactions during treatment, and be evaluated by the scale before and after treatment.

The researchers will compare the pharmacogenomics test group with the healthy control group to see the effect of drug therapy under the guidance of pharmacogenomics test on the efficacy of patients with depression.

Full description

Drug treatment of mental disorders is often seriously hindered by huge differences in individual drug responses or drug side effects, which are closely related to genetic factors. Pharmacogenomics testing can help clinicians to provide better drug choices for patients. In this study, a single center randomized controlled design was used, including 300 cases in the drug gene detection group and 300 cases in the healthy control group. Hamilton Depression scale (HAMD) and side effects scale (TESS) were used to evaluate the efficacy of pharmacogenomics test in the treatment of depression before and after treatment.

Enrollment: 665 patients

Sex: All

Ages: 14 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Diagnosis of depressive disorder based on DSM-V criteria by two or more senior psychiatrists; 2) Hamilton Depression Scale (HAMD) score more than 14; 3) Age between 14 and 75 years; 4) Completed at least middle school education or higher and capable of completing the assessment scales; 5) Good compliance with medication treatment.

Exclusion criteria

1. Presence of mental retardation or significant medical history of other major physical illnesses (including a history of cranial trauma or infection, intracranial tumors, cerebrovascular diseases, epilepsy, etc.); 2) History of benzodiazepine sedative-hypnotic drug, alcohol, or other substance abuse; 3) History of electroconvulsive therapy; 4) Pregnancy or lactation.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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665 participants in 2 patient groups

Pharmacogenomic testing group

Experimental group

Description:

In the pharmacogenomic testing group, patients underwent collection of oral mucosal epithelial cells for common psychiatric drug gene testing, the clinical doctors were required to combine the patients' symptom characteristics with their own clinical experience and refer to the results of pharmacogenomic testing to guide drug treatment.

Treatment:

Diagnostic Test: pharmacogenomic testing

Control

No Intervention group

Description:

In the control group, patients did not undergo pharmacogenomic testing, and the clinical doctors were required to provide drug treatment based on their own diagnostic and therapeutic experience and the patients' symptom characteristics.