Pharmacogenomics on Individualized Precise Treatment of Patients With Depression
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ClinicalTrials.gov Identifier: NCT05669391 |
Recruitment Status :
Not yet recruiting
First Posted : December 30, 2022
Last Update Posted : January 3, 2023
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pharmacogenomics Depression | Diagnostic Test: Genomic analysis of antidepressants | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated 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 |
Estimated Study Start Date : | January 1, 2023 |
Estimated Primary Completion Date : | December 31, 2025 |
Estimated Study Completion Date : | December 31, 2026 |
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 |
- Genomic analysis of antidepressants [ Time Frame: 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 [ Time Frame: Baseline ]Evaluate the severity and treatment effect of the patient's depression within one week.
- 17-items Hamilton Depression Scale [ Time Frame: Week 4 ]Evaluate the severity and treatment effect of the patient's depression within one week.
- 17-items Hamilton Depression Scale [ Time Frame: Week 8 ]Evaluate the severity and treatment effect of the patient's depression within one week.
- 17-items Hamilton Depression Scale [ Time Frame: Week 16 ]Evaluate the severity and treatment effect of the patient's depression within one week.
- 17-items Hamilton Depression Scale [ Time Frame: Week 32 ]Evaluate the severity and treatment effect of the patient's depression within one week.
- Dimensional Anhedonia Rating Scale [ Time Frame: Baseline ]Assess the patient's level of interest, motivation, effort, and happiness in experiencing pleasant activities or experiences.
- Dimensional Anhedonia Rating Scale [ Time Frame: Week 4 ]Assess the patient's level of interest, motivation, effort, and happiness in experiencing pleasant activities or experiences.
- Dimensional Anhedonia Rating Scale [ Time Frame: Week 8 ]Assess the patient's level of interest, motivation, effort, and happiness in experiencing pleasant activities or experiences.
- Dimensional Anhedonia Rating Scale [ Time Frame: Week 16 ]Assess the patient's level of interest, motivation, effort, and happiness in experiencing pleasant activities or experiences.
- Dimensional Anhedonia Rating Scale [ Time Frame: Week 32 ]Assess the patient's level of interest, motivation, effort, and happiness in experiencing pleasant activities or experiences.
- Antidepressant Side-Effect Checklist [ Time Frame: Baseline ]Evaluate the adverse reactions of patients after using antidepressants.
- Antidepressant Side-Effect Checklist [ Time Frame: Week 4 ]Evaluate the adverse reactions of patients after using antidepressants.
- Antidepressant Side-Effect Checklist [ Time Frame: Week 8 ]Evaluate the adverse reactions of patients after using antidepressants.
- Antidepressant Side-Effect Checklist [ Time Frame: Week 16 ]Evaluate the adverse reactions of patients after using antidepressants.
- Antidepressant Side-Effect Checklist [ Time Frame: Week 32 ]Evaluate the adverse reactions of patients after using antidepressants.
- Perceived deficits questionnaire [ Time Frame: Baseline ]Assess the patient's subjective cognitive function within one week.
- Perceived deficits questionnaire [ Time Frame: Week 4 ]Assess the patient's subjective cognitive function within one week.
- Perceived deficits questionnaire [ Time Frame: Week 8 ]Assess the patient's subjective cognitive function within one week.
- Perceived deficits questionnaire [ Time Frame: Week 16 ]Assess the patient's subjective cognitive function within one week.
- Perceived deficits questionnaire [ Time Frame: Week 32 ]Assess the patient's subjective cognitive function within one week.
- Hamilton Anxiety Scale [ Time Frame: Baseline ]Assess the severity of the patient's anxiety symptoms.
- Hamilton Anxiety Scale [ Time Frame: Week 4 ]Assess the severity of the patient's anxiety symptoms.
- Hamilton Anxiety Scale [ Time Frame: Week 8 ]Assess the severity of the patient's anxiety symptoms.
- Hamilton Anxiety Scale [ Time Frame: Week 16 ]Assess the severity of the patient's anxiety symptoms.
- Hamilton Anxiety Scale [ Time Frame: Week 32 ]Assess the severity of the patient's anxiety symptoms.
- Pittsburgh sleep quality index [ Time Frame: Baseline ]Evaluate the patient's sleep quality within one month, including sleep effect and duration.
- Pittsburgh sleep quality index [ Time Frame: Week 4 ]Evaluate the patient's sleep quality within one month, including sleep effect and duration.
- Pittsburgh sleep quality index [ Time Frame: Week 8 ]Evaluate the patient's sleep quality within one month, including sleep effect and duration.
- Pittsburgh sleep quality index [ Time Frame: Week 16 ]Evaluate the patient's sleep quality within one month, including sleep effect and duration.
- Pittsburgh sleep quality index [ Time Frame: Week 32 ]Evaluate the patient's sleep quality within one month, including sleep effect and duration.
- Short-form 36 item health survey questionnaire [ Time Frame: Baseline ]Assess the patient's health and quality of life within one month
- Short-form 36 item health survey questionnaire [ Time Frame: Week 4 ]Assess the patient's health and quality of life within one month
- Short-form 36 item health survey questionnaire [ Time Frame: Week 8 ]Assess the patient's health and quality of life within one month
- Short-form 36 item health survey questionnaire [ Time Frame: Week 16 ]Assess the patient's health and quality of life within one month
- Short-form 36 item health survey questionnaire [ Time Frame: Week 32 ]Assess the patient's health and quality of life within one month
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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05669391
Contact: Xirong Sun, M.D. | 86-2168306699 | xirongsun@163.com |
Responsible Party: | Jie Tong, Clinical Professor, Tongji University |
ClinicalTrials.gov Identifier: | NCT05669391 |
Other Study ID Numbers: |
PWZxk2022-18 |
First Posted: | December 30, 2022 Key Record Dates |
Last Update Posted: | January 3, 2023 |
Last Verified: | December 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Pharmacogenomics depression Precision treatment Antidepressants |
Depression Depressive Disorder Behavioral Symptoms Mood Disorders |
Mental Disorders Antidepressive Agents Psychotropic Drugs |