Pharmacogenomics on Individualized Precise Treatment of Patients with Depression

NCT ID: NCT05669391

Last Updated: 2025-02-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2024-12-31

Brief Summary

Based on pharmacogenomics analysis technology, this topic explored its impact on individualized precise treatment of patients with depression through randomized controlled trials. The study subjects were depression patients from the mental health research center affiliated to Tongji University. The sample size was estimated by PASS 21.0.3 software. The sample size of the intervention group and the control group was 60 cases each, and SPSS 25.0 software was used for random sampling. The intervention group completed the pharmacogenomic analysis of antidepressants before using them, and selected appropriate antidepressants according to the characteristics of pharmacokinetics and pharmacodynamics of individual patients, while the control group was administered according to routine treatment. 17 items Hamilton Compression Scale (HAMD-17), Hamilton Anxiety Scale (HAMA), Dimensional Anhedonia Rating Scale (DARS), Pittsburgh sleep quality index (PSQI), Antidepressant Side Effect Checklist (ASEC), Short form 36 item health survey questionnaire (SF-36) (PDQ) assessment. R Project 4.1.1 software was used for statistical analysis of data, PLink v1.07 and Haploview software were used for association analysis of whole genome and drug efficacy and adverse reactions. To explore the difference between the reduction rate of drug efficacy and adverse reactions in patients with depression after pharmacogenomics intervention and conventional treatment. At the same time, we verified and found the gene loci related to the efficacy and adverse reactions of antidepressants in the East Asian population.

Conditions

Pharmacogenomics; Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: TRIPLE

Study Groups

Pharmacogenomics Group

Group Type: EXPERIMENTAL

Genomic analysis of antidepressants

Intervention Type: DIAGNOSTIC_TEST

Genomic analysis of all antidepressants. Tris EDTA anticoagulation and salting out were used to extract DNA. OD 260/280 was between 1.6-1.8 and the concentration was greater than 50 ng/ μ L。 Using the PCR gene chip detection method and the Asian Screening Array (ASA) chip detection technology of Illumina Company (this chip is the first whole genome SNP chip designed based on the whole genome sequencing data of 9000+East Asian populations, which contains 750000 markers, with 85% of the effective loci), we can obtain the genetic information of polymorphic loci related to the individual differences of drug effects of subjects.

Non Pharmacogenomics Group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Genomic analysis of antidepressants

Genomic analysis of all antidepressants. Tris EDTA anticoagulation and salting out were used to extract DNA. OD 260/280 was between 1.6-1.8 and the concentration was greater than 50 ng/ μ L。 Using the PCR gene chip detection method and the Asian Screening Array (ASA) chip detection technology of Illumina Company (this chip is the first whole genome SNP chip designed based on the whole genome sequencing data of 9000+East Asian populations, which contains 750000 markers, with 85% of the effective loci), we can obtain the genetic information of polymorphic loci related to the individual differences of drug effects of subjects.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

1. Both biological parents are Chinese nationals;

2. Conform to the diagnostic criteria of depression in the fifth edition of the American Diagnostic and Statistical Manual of Mental Disorders (DSM-5);

3. The total score of 17 items of Hamilton Depression Scale (HAMD-17) is ≥ 17;

4. Never used relevant antidepressant drugs;

5. Have a certain visual and auditory discrimination, and have no understanding obstacle;

6. Be able to independently complete the scale measurement;

7. Education level above primary school;

8. Obtain the written informed consent of the patient. If the patient is incapacitated during the onset of the disease, the written informed consent of the legal guardian is required.

Exclusion Criteria

1. Patients with schizophrenia, schizoaffective disorder, bipolar affective disorder, mental retardation, generalized developmental disorder, delirium, dementia, cognitive dysfunction, alcohol dependence and other diagnoses;

2. Suffering from serious organic diseases, such as diabetes, thyroid disease, hypertension, cardiovascular disease, brain injury, cerebral ischemia or hemorrhage;

3. Patients with narrow angle glaucoma;

4. History of epilepsy and febrile convulsion;

5. Those who have taken drugs in the past;

6. Syphilis specific antibody and AIDS antibody are positive;

7. Those who received MECT or rTMS and other neuromodulation therapy one month before enrollment;

8. The risk assessment indicates that there is a serious suicide attempt or excitement;

9. Laboratory examination indicates that liver function and renal function are impaired;

10. Pregnant or lactating women, or those who plan to have a pregnancy in the near future;

11. Other contraindications of antidepressants.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tongji University

OTHER

Sponsor Role: lead

Responsible Party

Jie Tong

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tongji University

Shanghai, Shanghai Municipality, China

Countries

China

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Other Identifiers

PWZxk2022-18

Identifier Type: -

Identifier Source: org_study_id