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

Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05959187
• Other study ID #: 2023-07-12
• Status: Completed
• Phase: N/A
• Start date: July 15, 2020
• Est. completion date: March 30, 2023

Study information

• Verified date: July 2023
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 665
• Est. completion date: March 30, 2023
• Est. primary completion date: March 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Diagnostic Test:
• pharmacogenomic testing
Pharmacogenomic testing has emerged as a promising diagnostic tool, allowing clinicians to guide the selection and dosage of antidepressant medications. In theory, pharmacogenomic testing may provide improved drug selection and dosing strategies for patients with genetic alterations related to drug response

Locations

Country	Name	City	State
China	Second Affiliated Hospital, School of Medicine, Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	remission	remission, defined as a HAMD-24 score of 7 or less after treatment.	Change the percentage of remission from baseline in the fourth week of intervention
Primary	response	response, defined as a HAMD-24 score at least 50% decrease from the baseline.	Change the percentage of response from baseline in the fourth week of intervention