Pharmacogenomics on Individualized Precise Treatment of Patients with Depression

Not Applicable

Completed

• Conditions: Pharmacogenomics; Depression
• Interventions: Diagnostic Test: Genomic analysis of antidepressants

• Registration Number: NCT05669391
• Lead Sponsor: Tongji University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-12-20
• Study First Submitted QC: 2022-12-20
• Study First Posted: 2022-12-30
• Status Verified: 2023-01
• Study Start: 2023-01-01
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31
• Last Update Submitted: 2025-02-16
• Last Update Posted: 2025-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pharmacogenomics Group	Genomic analysis of antidepressants	-

Primary Outcome Measures

Name	Time	Method
17-items Hamilton Depression Scale	Week 32	Evaluate the severity and treatment effect of the patient's depression within one week.
Perceived deficits questionnaire	Week 32	Assess the patient's subjective cognitive function within one week.
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.
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	Week 32	Evaluate the adverse reactions of patients after using antidepressants.

Secondary Outcome Measures

Name	Time	Method
Hamilton Anxiety Scale	Week 32	Assess the severity of the patient's anxiety symptoms.
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	Week 32	Assess the patient's health and quality of life within one month

Trial Locations

Locations (1)

Tongji University; 🇨🇳 Shanghai, Shanghai, China