Back to resultsA Single-center Randomized Controlled Study on the Effect of Pharmacogenomics Trial on Clinical Efficacy in Patients With Depression
Primary Purpose
Depressive Disorder, Pharmacogenomic Drug Interaction
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
pharmacogenomic testing
Sponsored by
About this trial
This is an interventional treatment trial for Depressive Disorder focused on measuring Depressive Disorder, Pharmacogenomic Drug Interaction
Eligibility Criteria
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.
Sites / Locations
- Second Affiliated Hospital, School of Medicine, Zhejiang University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Pharmacogenomic testing group
Control
Arm 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.
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.
Outcomes
Primary Outcome Measures
remission
remission, defined as a HAMD-24 score of 7 or less after treatment.
response
response, defined as a HAMD-24 score at least 50% decrease from the baseline.
Secondary Outcome Measures
Full Information
NCT ID
NCT05959187
First Posted
July 17, 2023
Last Updated
July 17, 2023
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
1. Study Identification
Unique Protocol Identification Number
NCT05959187
Brief Title
A Single-center Randomized Controlled Study on the Effect of Pharmacogenomics Trial on Clinical Efficacy in Patients With Depression
Official Title
A Single-center Randomized Controlled Study on the Effect of Pharmacogenomics Trial on Clinical Efficacy in Patients With Depression
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
July 15, 2020 (Actual)
Primary Completion Date
March 30, 2023 (Actual)
Study Completion Date
March 30, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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:
Whether the drug treatment regimen under the guidance of pharmacogenomics test is beneficial to the rehabilitation of patients with depression.
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder, Pharmacogenomic Drug Interaction
Keywords
Depressive Disorder, Pharmacogenomic Drug Interaction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
665 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pharmacogenomic testing group
Arm Type
Experimental
Arm 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.
Arm Title
Control
Arm Type
No Intervention
Arm 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.
Intervention Type
Diagnostic Test
Intervention Name(s)
pharmacogenomic testing
Intervention Description
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
Primary Outcome Measure Information:
Title
remission
Description
remission, defined as a HAMD-24 score of 7 or less after treatment.
Time Frame
Change the percentage of remission from baseline in the fourth week of intervention
Title
response
Description
response, defined as a HAMD-24 score at least 50% decrease from the baseline.
Time Frame
Change the percentage of response from baseline in the fourth week of intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zheng Lin
Organizational Affiliation
Second Affiliated Hospital, School of Medicine, Zhejiang University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Second Affiliated Hospital, School of Medicine, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
12. IPD Sharing Statement
Learn more about this trial
A Single-center Randomized Controlled Study on the Effect of Pharmacogenomics Trial on Clinical Efficacy in Patients With Depression
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