Clinical trial NCT05669391: Pharmacogenomics on Individualized Precise Treatment of Patients with Depression
Official title: Randomized Controlled Study on the Effect of Pharmacogenomics on Individualized Precise Treatment of Patients with Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pharmacogenomics
Depression
Keywords: Pharmacogenomics
depression
Precision treatment
Antidepressants
Lead sponsor: Tongji University
Sponsor class: OTHER
First posted: 2022-12-30
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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.

Primary outcomes:
measure: Genomic analysis of antidepressants
timeFrame: Baseline
measure: 17-items Hamilton Depression Scale
timeFrame: Baseline
measure: 17-items Hamilton Depression Scale
timeFrame: Week 4
measure: 17-items Hamilton Depression Scale
timeFrame: Week 8
measure: 17-items Hamilton Depression Scale
timeFrame: Week 16
measure: 17-items Hamilton Depression Scale
timeFrame: Week 32
measure: Dimensional Anhedonia Rating Scale
timeFrame: Baseline
measure: Dimensional Anhedonia Rating Scale
timeFrame: Week 4
measure: Dimensional Anhedonia Rating Scale
timeFrame: Week 8
measure: Dimensional Anhedonia Rating Scale
timeFrame: Week 16
measure: Dimensional Anhedonia Rating Scale
timeFrame: Week 32
measure: Antidepressant Side-Effect Checklist
timeFrame: Baseline
measure: Antidepressant Side-Effect Checklist
timeFrame: Week 4
measure: Antidepressant Side-Effect Checklist
timeFrame: Week 8
measure: Antidepressant Side-Effect Checklist
timeFrame: Week 16
measure: Antidepressant Side-Effect Checklist
timeFrame: Week 32
measure: Perceived deficits questionnaire
timeFrame: Baseline
measure: Perceived deficits questionnaire
timeFrame: Week 4
measure: Perceived deficits questionnaire
timeFrame: Week 8
measure: Perceived deficits questionnaire
timeFrame: Week 16
measure: Perceived deficits questionnaire
timeFrame: Week 32
Secondary outcomes:
measure: Hamilton Anxiety Scale
timeFrame: Baseline
measure: Hamilton Anxiety Scale
timeFrame: Week 4
measure: Hamilton Anxiety Scale
timeFrame: Week 8
measure: Hamilton Anxiety Scale
timeFrame: Week 16
measure: Hamilton Anxiety Scale
timeFrame: Week 32
measure: Pittsburgh sleep quality index
timeFrame: Baseline
measure: Pittsburgh sleep quality index
timeFrame: Week 4
measure: Pittsburgh sleep quality index
timeFrame: Week 8
measure: Pittsburgh sleep quality index
timeFrame: Week 16
measure: Pittsburgh sleep quality index
timeFrame: Week 32
measure: Short-form 36 item health survey questionnaire
timeFrame: Baseline
measure: Short-form 36 item health survey questionnaire
timeFrame: Week 4
measure: Short-form 36 item health survey questionnaire
timeFrame: Week 8
measure: Short-form 36 item health survey questionnaire
timeFrame: Week 16
measure: Short-form 36 item health survey questionnaire
timeFrame: Week 32
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Tongji University
state: Shanghai
Study officials:
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