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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:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pharmacogenomic testing group | Experimental | 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. |
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| Control | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pharmacogenomic testing | Diagnostic Test | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Zheng Lin | Second Affiliated Hospital, School of Medicine, Zhejiang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Second Affiliated Hospital, School of Medicine, Zhejiang University | Hangzhou | Zhejiang | 310000 | China |
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|
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| ID | Term |
|---|---|
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000071185 | Pharmacogenomic Testing |
| ID | Term |
|---|---|
| D005820 | Genetic Testing |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
| D005821 | Genetic Techniques |
| D033142 | Genetic Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D003954 | Diagnostic Services |
| D011314 | Preventive Health Services |
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