Pharmacogenomics on Individualized Precise Treatment of Patients with Depression

NCT05669391 | Completed

• 1 other identifier: PWZxk2022-18
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Pharmacogenomics; Depression

Keywords

Pharmacogenomics; depression; Precision treatment; Antidepressants

Outcome Measures

Primary Outcomes (21)

• 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.

  Baseline

• 17-items Hamilton Depression Scale

  Evaluate the severity and treatment effect of the patient's depression within one week.

  Baseline

• 17-items Hamilton Depression Scale

  Evaluate the severity and treatment effect of the patient's depression within one week.

  Week 4

• 17-items Hamilton Depression Scale

  Evaluate the severity and treatment effect of the patient's depression within one week.

  Week 8

• 17-items Hamilton Depression Scale

  Evaluate the severity and treatment effect of the patient's depression within one week.

  Week 16

• 17-items Hamilton Depression Scale

  Evaluate the severity and treatment effect of the patient's depression within one week.

  Week 32

• Dimensional Anhedonia Rating Scale

  Assess the patient's level of interest, motivation, effort, and happiness in experiencing pleasant activities or experiences.

  Baseline

• Dimensional Anhedonia Rating Scale

  Assess the patient's level of interest, motivation, effort, and happiness in experiencing pleasant activities or experiences.

  Week 4

• Dimensional Anhedonia Rating Scale

  Assess the patient's level of interest, motivation, effort, and happiness in experiencing pleasant activities or experiences.

  Week 8

• Dimensional Anhedonia Rating Scale

  Assess the patient's level of interest, motivation, effort, and happiness in experiencing pleasant activities or experiences.

  Week 16

• Dimensional Anhedonia Rating Scale

  Assess the patient's level of interest, motivation, effort, and happiness in experiencing pleasant activities or experiences.

  Week 32

• Antidepressant Side-Effect Checklist

  Evaluate the adverse reactions of patients after using antidepressants.

  Baseline

• Antidepressant Side-Effect Checklist

  Evaluate the adverse reactions of patients after using antidepressants.

  Week 4

• Antidepressant Side-Effect Checklist

  Evaluate the adverse reactions of patients after using antidepressants.

  Week 8

• Antidepressant Side-Effect Checklist

  Evaluate the adverse reactions of patients after using antidepressants.

  Week 16

• Antidepressant Side-Effect Checklist

  Evaluate the adverse reactions of patients after using antidepressants.

  Week 32

• Perceived deficits questionnaire

  Assess the patient's subjective cognitive function within one week.

  Baseline

• Perceived deficits questionnaire

  Assess the patient's subjective cognitive function within one week.

  Week 4

• Perceived deficits questionnaire

  Assess the patient's subjective cognitive function within one week.

  Week 8

• Perceived deficits questionnaire

  Assess the patient's subjective cognitive function within one week.

  Week 16

• Perceived deficits questionnaire

  Assess the patient's subjective cognitive function within one week.

  Week 32

Secondary Outcomes (15)

• Hamilton Anxiety Scale

  Baseline

• Hamilton Anxiety Scale

  Week 4

• Hamilton Anxiety Scale

  Week 8

• Hamilton Anxiety Scale

  Week 16

• Hamilton Anxiety Scale

  Week 32

Study Arms (2)

Pharmacogenomics Group

EXPERIMENTAL

Diagnostic Test: Genomic analysis of antidepressants

Non Pharmacogenomics Group

NO INTERVENTION

Interventions

Genomic analysis of antidepressants DIAGNOSTIC_TEST

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.

Pharmacogenomics Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tongji University: lead

Study Sites (1)

Tongji University

Shanghai, Shanghai Municipality, 200124, China

Location

Related Publications (11)

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• Aldrich SL, Poweleit EA, Prows CA, Martin LJ, Strawn JR, Ramsey LB. Influence of CYP2C19 Metabolizer Status on Escitalopram/Citalopram Tolerability and Response in Youth With Anxiety and Depressive Disorders. Front Pharmacol. 2019 Feb 19;10:99. doi: 10.3389/fphar.2019.00099. eCollection 2019.

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• Gasso P, Rodriguez N, Blazquez A, Monteagudo A, Boloc D, Plana MT, Lafuente A, Lazaro L, Arnaiz JA, Mas S. Epigenetic and genetic variants in the HTR1B gene and clinical improvement in children and adolescents treated with fluoxetine. Prog Neuropsychopharmacol Biol Psychiatry. 2017 Apr 3;75:28-34. doi: 10.1016/j.pnpbp.2016.12.003. Epub 2016 Dec 23.

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• Health Quality Ontario. Pharmacogenomic Testing for Psychotropic Medication Selection: A Systematic Review of the Assurex GeneSight Psychotropic Test. Ont Health Technol Assess Ser. 2017 Apr 11;17(4):1-39. eCollection 2017.

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  PMID: 40852613 DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: December 20, 2022
• First Posted: December 30, 2022
• Study Start: January 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: February 19, 2025

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)