Pharmacogenomics on Individualized Precise Treatment of Patients With Depression

Sponsor

Tongji University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05669391

Collaborator

(none)

120

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pharmacogenomics Depression	Diagnostic Test: Genomic analysis of antidepressants	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Health Services Research

Official Title:

Randomized Controlled Study on the Effect of Pharmacogenomics on Individualized Precise Treatment of Patients With Depression

Anticipated Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2025

Anticipated Study Completion Date :

Dec 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pharmacogenomics Group	Diagnostic Test: 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.
No Intervention: Non Pharmacogenomics Group

Arm

Intervention/Treatment

Experimental: Pharmacogenomics Group

Diagnostic Test: 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.

No Intervention: Non Pharmacogenomics Group

Outcome Measures

Primary Outcome Measures

Genomic analysis of antidepressants [Baseline]
Using PCR gene chip detection method and Asian Screening Array (ASA) chip detection technology of Illumina Company, we can obtain the genetic information of polymorphic sites related to the individual differences of drug effects of subjects.
17-items Hamilton Depression Scale [Baseline]
Evaluate the severity and treatment effect of the patient's depression within one week.
17-items Hamilton Depression Scale [Week 4]
Evaluate the severity and treatment effect of the patient's depression within one week.
17-items Hamilton Depression Scale [Week 8]
Evaluate the severity and treatment effect of the patient's depression within one week.
17-items Hamilton Depression Scale [Week 16]
Evaluate the severity and treatment effect of the patient's depression within one week.
17-items Hamilton Depression Scale [Week 32]
Evaluate the severity and treatment effect of the patient's depression within one week.
Dimensional Anhedonia Rating Scale [Baseline]
Assess the patient's level of interest, motivation, effort, and happiness in experiencing pleasant activities or experiences.
Dimensional Anhedonia Rating Scale [Week 4]
Assess the patient's level of interest, motivation, effort, and happiness in experiencing pleasant activities or experiences.
Dimensional Anhedonia Rating Scale [Week 8]
Assess the patient's level of interest, motivation, effort, and happiness in experiencing pleasant activities or experiences.
Dimensional Anhedonia Rating Scale [Week 16]
Assess the patient's level of interest, motivation, effort, and happiness in experiencing pleasant activities or experiences.
Dimensional Anhedonia Rating Scale [Week 32]
Assess the patient's level of interest, motivation, effort, and happiness in experiencing pleasant activities or experiences.
Antidepressant Side-Effect Checklist [Baseline]
Evaluate the adverse reactions of patients after using antidepressants.
Antidepressant Side-Effect Checklist [Week 4]
Evaluate the adverse reactions of patients after using antidepressants.
Antidepressant Side-Effect Checklist [Week 8]
Evaluate the adverse reactions of patients after using antidepressants.
Antidepressant Side-Effect Checklist [Week 16]
Evaluate the adverse reactions of patients after using antidepressants.
Antidepressant Side-Effect Checklist [Week 32]
Evaluate the adverse reactions of patients after using antidepressants.
Perceived deficits questionnaire [Baseline]
Assess the patient's subjective cognitive function within one week.
Perceived deficits questionnaire [Week 4]
Assess the patient's subjective cognitive function within one week.
Perceived deficits questionnaire [Week 8]
Assess the patient's subjective cognitive function within one week.
Perceived deficits questionnaire [Week 16]
Assess the patient's subjective cognitive function within one week.
Perceived deficits questionnaire [Week 32]
Assess the patient's subjective cognitive function within one week.

Secondary Outcome Measures

Hamilton Anxiety Scale [Baseline]
Assess the severity of the patient's anxiety symptoms.
Hamilton Anxiety Scale [Week 4]
Assess the severity of the patient's anxiety symptoms.
Hamilton Anxiety Scale [Week 8]
Assess the severity of the patient's anxiety symptoms.
Hamilton Anxiety Scale [Week 16]
Assess the severity of the patient's anxiety symptoms.
Hamilton Anxiety Scale [Week 32]
Assess the severity of the patient's anxiety symptoms.
Pittsburgh sleep quality index [Baseline]
Evaluate the patient's sleep quality within one month, including sleep effect and duration.
Pittsburgh sleep quality index [Week 4]
Evaluate the patient's sleep quality within one month, including sleep effect and duration.
Pittsburgh sleep quality index [Week 8]
Evaluate the patient's sleep quality within one month, including sleep effect and duration.
Pittsburgh sleep quality index [Week 16]
Evaluate the patient's sleep quality within one month, including sleep effect and duration.
Pittsburgh sleep quality index [Week 32]
Evaluate the patient's sleep quality within one month, including sleep effect and duration.
Short-form 36 item health survey questionnaire [Baseline]
Assess the patient's health and quality of life within one month
Short-form 36 item health survey questionnaire [Week 4]
Assess the patient's health and quality of life within one month
Short-form 36 item health survey questionnaire [Week 8]
Assess the patient's health and quality of life within one month
Short-form 36 item health survey questionnaire [Week 16]
Assess the patient's health and quality of life within one month
Short-form 36 item health survey questionnaire [Week 32]
Assess the patient's health and quality of life within one month

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Both biological parents are Chinese nationals;
Conform to the diagnostic criteria of depression in the fifth edition of the American Diagnostic and Statistical Manual of Mental Disorders (DSM-5);
The total score of 17 items of Hamilton Depression Scale (HAMD-17) is ≥ 17;
Never used relevant antidepressant drugs;
Have a certain visual and auditory discrimination, and have no understanding obstacle;
Be able to independently complete the scale measurement;
Education level above primary school;
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:

Patients with schizophrenia, schizoaffective disorder, bipolar affective disorder, mental retardation, generalized developmental disorder, delirium, dementia, cognitive dysfunction, alcohol dependence and other diagnoses;
Suffering from serious organic diseases, such as diabetes, thyroid disease, hypertension, cardiovascular disease, brain injury, cerebral ischemia or hemorrhage;
Patients with narrow angle glaucoma;
History of epilepsy and febrile convulsion;
Those who have taken drugs in the past;
Syphilis specific antibody and AIDS antibody are positive;
Those who received MECT or rTMS and other neuromodulation therapy one month before enrollment;
The risk assessment indicates that there is a serious suicide attempt or excitement;
Laboratory examination indicates that liver function and renal function are impaired;
Pregnant or lactating women, or those who plan to have a pregnancy in the near future;
Other contraindications of antidepressants.