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Pharmacogenomics on Individualized Precise Treatment of Patients With Depression

Primary Purpose

Pharmacogenomics, Depression

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Genomic analysis of antidepressants
Sponsored by
Tongji University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Pharmacogenomics focused on measuring Pharmacogenomics, depression, Precision treatment, Antidepressants

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Pharmacogenomics Group

    Non Pharmacogenomics Group

    Arm Description

    Outcomes

    Primary Outcome Measures

    Genomic analysis of antidepressants
    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
    Evaluate the severity and treatment effect of the patient's depression within one week.
    17-items Hamilton Depression Scale
    Evaluate the severity and treatment effect of the patient's depression within one week.
    17-items Hamilton Depression Scale
    Evaluate the severity and treatment effect of the patient's depression within one week.
    17-items Hamilton Depression Scale
    Evaluate the severity and treatment effect of the patient's depression within one week.
    17-items Hamilton Depression Scale
    Evaluate the severity and treatment effect of the patient's depression within one week.
    Dimensional Anhedonia Rating Scale
    Assess the patient's level of interest, motivation, effort, and happiness in experiencing pleasant activities or experiences.
    Dimensional Anhedonia Rating Scale
    Assess the patient's level of interest, motivation, effort, and happiness in experiencing pleasant activities or experiences.
    Dimensional Anhedonia Rating Scale
    Assess the patient's level of interest, motivation, effort, and happiness in experiencing pleasant activities or experiences.
    Dimensional Anhedonia Rating Scale
    Assess the patient's level of interest, motivation, effort, and happiness in experiencing pleasant activities or experiences.
    Dimensional Anhedonia Rating Scale
    Assess the patient's level of interest, motivation, effort, and happiness in experiencing pleasant activities or experiences.
    Antidepressant Side-Effect Checklist
    Evaluate the adverse reactions of patients after using antidepressants.
    Antidepressant Side-Effect Checklist
    Evaluate the adverse reactions of patients after using antidepressants.
    Antidepressant Side-Effect Checklist
    Evaluate the adverse reactions of patients after using antidepressants.
    Antidepressant Side-Effect Checklist
    Evaluate the adverse reactions of patients after using antidepressants.
    Antidepressant Side-Effect Checklist
    Evaluate the adverse reactions of patients after using antidepressants.
    Perceived deficits questionnaire
    Assess the patient's subjective cognitive function within one week.
    Perceived deficits questionnaire
    Assess the patient's subjective cognitive function within one week.
    Perceived deficits questionnaire
    Assess the patient's subjective cognitive function within one week.
    Perceived deficits questionnaire
    Assess the patient's subjective cognitive function within one week.
    Perceived deficits questionnaire
    Assess the patient's subjective cognitive function within one week.

    Secondary Outcome Measures

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

    Full Information

    First Posted
    December 20, 2022
    Last Updated
    December 29, 2022
    Sponsor
    Tongji University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05669391
    Brief Title
    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

    2. Study Status

    Record Verification Date
    December 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 1, 2023 (Anticipated)
    Primary Completion Date
    December 31, 2025 (Anticipated)
    Study Completion Date
    December 31, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Tongji University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pharmacogenomics, Depression
    Keywords
    Pharmacogenomics, depression, Precision treatment, Antidepressants

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    120 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Pharmacogenomics Group
    Arm Type
    Experimental
    Arm Title
    Non Pharmacogenomics Group
    Arm Type
    No Intervention
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Genomic analysis of antidepressants
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Genomic analysis of antidepressants
    Description
    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.
    Time Frame
    Baseline
    Title
    17-items Hamilton Depression Scale
    Description
    Evaluate the severity and treatment effect of the patient's depression within one week.
    Time Frame
    Baseline
    Title
    17-items Hamilton Depression Scale
    Description
    Evaluate the severity and treatment effect of the patient's depression within one week.
    Time Frame
    Week 4
    Title
    17-items Hamilton Depression Scale
    Description
    Evaluate the severity and treatment effect of the patient's depression within one week.
    Time Frame
    Week 8
    Title
    17-items Hamilton Depression Scale
    Description
    Evaluate the severity and treatment effect of the patient's depression within one week.
    Time Frame
    Week 16
    Title
    17-items Hamilton Depression Scale
    Description
    Evaluate the severity and treatment effect of the patient's depression within one week.
    Time Frame
    Week 32
    Title
    Dimensional Anhedonia Rating Scale
    Description
    Assess the patient's level of interest, motivation, effort, and happiness in experiencing pleasant activities or experiences.
    Time Frame
    Baseline
    Title
    Dimensional Anhedonia Rating Scale
    Description
    Assess the patient's level of interest, motivation, effort, and happiness in experiencing pleasant activities or experiences.
    Time Frame
    Week 4
    Title
    Dimensional Anhedonia Rating Scale
    Description
    Assess the patient's level of interest, motivation, effort, and happiness in experiencing pleasant activities or experiences.
    Time Frame
    Week 8
    Title
    Dimensional Anhedonia Rating Scale
    Description
    Assess the patient's level of interest, motivation, effort, and happiness in experiencing pleasant activities or experiences.
    Time Frame
    Week 16
    Title
    Dimensional Anhedonia Rating Scale
    Description
    Assess the patient's level of interest, motivation, effort, and happiness in experiencing pleasant activities or experiences.
    Time Frame
    Week 32
    Title
    Antidepressant Side-Effect Checklist
    Description
    Evaluate the adverse reactions of patients after using antidepressants.
    Time Frame
    Baseline
    Title
    Antidepressant Side-Effect Checklist
    Description
    Evaluate the adverse reactions of patients after using antidepressants.
    Time Frame
    Week 4
    Title
    Antidepressant Side-Effect Checklist
    Description
    Evaluate the adverse reactions of patients after using antidepressants.
    Time Frame
    Week 8
    Title
    Antidepressant Side-Effect Checklist
    Description
    Evaluate the adverse reactions of patients after using antidepressants.
    Time Frame
    Week 16
    Title
    Antidepressant Side-Effect Checklist
    Description
    Evaluate the adverse reactions of patients after using antidepressants.
    Time Frame
    Week 32
    Title
    Perceived deficits questionnaire
    Description
    Assess the patient's subjective cognitive function within one week.
    Time Frame
    Baseline
    Title
    Perceived deficits questionnaire
    Description
    Assess the patient's subjective cognitive function within one week.
    Time Frame
    Week 4
    Title
    Perceived deficits questionnaire
    Description
    Assess the patient's subjective cognitive function within one week.
    Time Frame
    Week 8
    Title
    Perceived deficits questionnaire
    Description
    Assess the patient's subjective cognitive function within one week.
    Time Frame
    Week 16
    Title
    Perceived deficits questionnaire
    Description
    Assess the patient's subjective cognitive function within one week.
    Time Frame
    Week 32
    Secondary Outcome Measure Information:
    Title
    Hamilton Anxiety Scale
    Description
    Assess the severity of the patient's anxiety symptoms.
    Time Frame
    Baseline
    Title
    Hamilton Anxiety Scale
    Description
    Assess the severity of the patient's anxiety symptoms.
    Time Frame
    Week 4
    Title
    Hamilton Anxiety Scale
    Description
    Assess the severity of the patient's anxiety symptoms.
    Time Frame
    Week 8
    Title
    Hamilton Anxiety Scale
    Description
    Assess the severity of the patient's anxiety symptoms.
    Time Frame
    Week 16
    Title
    Hamilton Anxiety Scale
    Description
    Assess the severity of the patient's anxiety symptoms.
    Time Frame
    Week 32
    Title
    Pittsburgh sleep quality index
    Description
    Evaluate the patient's sleep quality within one month, including sleep effect and duration.
    Time Frame
    Baseline
    Title
    Pittsburgh sleep quality index
    Description
    Evaluate the patient's sleep quality within one month, including sleep effect and duration.
    Time Frame
    Week 4
    Title
    Pittsburgh sleep quality index
    Description
    Evaluate the patient's sleep quality within one month, including sleep effect and duration.
    Time Frame
    Week 8
    Title
    Pittsburgh sleep quality index
    Description
    Evaluate the patient's sleep quality within one month, including sleep effect and duration.
    Time Frame
    Week 16
    Title
    Pittsburgh sleep quality index
    Description
    Evaluate the patient's sleep quality within one month, including sleep effect and duration.
    Time Frame
    Week 32
    Title
    Short-form 36 item health survey questionnaire
    Description
    Assess the patient's health and quality of life within one month
    Time Frame
    Baseline
    Title
    Short-form 36 item health survey questionnaire
    Description
    Assess the patient's health and quality of life within one month
    Time Frame
    Week 4
    Title
    Short-form 36 item health survey questionnaire
    Description
    Assess the patient's health and quality of life within one month
    Time Frame
    Week 8
    Title
    Short-form 36 item health survey questionnaire
    Description
    Assess the patient's health and quality of life within one month
    Time Frame
    Week 16
    Title
    Short-form 36 item health survey questionnaire
    Description
    Assess the patient's health and quality of life within one month
    Time Frame
    Week 32

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Xirong Sun, M.D.
    Phone
    86-2168306699
    Email
    xirongsun@163.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    9915229
    Citation
    Cremonesi L, Carrera P, Cardillo E, Fumagalli A, Lucchiari S, Ferrari M, Righetti SC, Righetti PG, Gelfi C. Optimized detection of DNA point mutations by double gradient denaturing gradient gel electrophoresis. Clin Chem Lab Med. 1998 Dec;36(12):959-61. doi: 10.1515/CCLM.1998.165.
    Results Reference
    result
    PubMed Identifier
    32780949
    Citation
    Rush AJ, South C, Jha MK, Jain SB, Trivedi MH. What to Expect When Switching to a Second Antidepressant Medication Following an Ineffective Initial SSRI: A Report From the Randomized Clinical STAR*D Study. J Clin Psychiatry. 2020 Aug 11;81(5):19m12949. doi: 10.4088/JCP.19m12949.
    Results Reference
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    32529266
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    Ahmadimanesh M, Balarastaghi S, Rashedinia M, Yazdian-Robati R. A systematic review on the genotoxic effect of serotonin and norepinephrine reuptake inhibitors (SNRIs) antidepressants. Psychopharmacology (Berl). 2020 Jul;237(7):1909-1915. doi: 10.1007/s00213-020-05550-8. Epub 2020 Jun 11.
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    Greden JF, Parikh SV, Rothschild AJ, Thase ME, Dunlop BW, DeBattista C, Conway CR, Forester BP, Mondimore FM, Shelton RC, Macaluso M, Li J, Brown K, Gilbert A, Burns L, Jablonski MR, Dechairo B. Impact of pharmacogenomics on clinical outcomes in major depressive disorder in the GUIDED trial: A large, patient- and rater-blinded, randomized, controlled study. J Psychiatr Res. 2019 Apr;111:59-67. doi: 10.1016/j.jpsychires.2019.01.003. Epub 2019 Jan 4.
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    Hattinger CM, Patrizio MP, Luppi S, Serra M. Pharmacogenomics and Pharmacogenetics in Osteosarcoma: Translational Studies and Clinical Impact. Int J Mol Sci. 2020 Jun 30;21(13):4659. doi: 10.3390/ijms21134659.
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    Pharmacogenomics on Individualized Precise Treatment of Patients With Depression

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