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PharmacogenomicsNCT05669391

Pharmacogenomics on Individualized Precise Treatment of Patients With Depression

A study testing Genomic analysis of antidepressants in people with Pharmacogenomics and Depression, run by Tongji University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Pharmacogenomics, Depression
What is being tested?
Genomic analysis of antidepressants
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteChina
Study dates
1 Jan 2023to 31 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Tongji University

    Shanghai, Shanghai Municipality, 200124

Other trials in China

About this study

Official title: Randomized Controlled Study on the Effect of Pharmacogenomics on Individualized Precise Treatment of Patients With Depression

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.

Being tested
Genomic analysis of antidepressants
Keywords
Pharmacogenomics, depression, Precision treatment, Antidepressants
Medical subject headings
Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Genomic analysis of antidepressantsDiagnostic 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.

Study groups in NCT05669391
Study groupRoleWhat they receive
Pharmacogenomics GroupExperimentalNot described
Receives: Diagnostic Test: Genomic analysis of antidepressants
Non Pharmacogenomics GroupNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline

  2. 17-items Hamilton Depression Scale

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

    Measured: Baseline

  3. 17-items Hamilton Depression Scale

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

    Measured: Week 4

  4. 17-items Hamilton Depression Scale

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

    Measured: Week 8

  5. 17-items Hamilton Depression Scale

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

    Measured: Week 16

  6. 17-items Hamilton Depression Scale

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

    Measured: Week 32

  7. Dimensional Anhedonia Rating Scale

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

    Measured: Baseline

  8. Dimensional Anhedonia Rating Scale

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

    Measured: Week 4

  9. Dimensional Anhedonia Rating Scale

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

    Measured: Week 8

  10. Dimensional Anhedonia Rating Scale

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

    Measured: Week 16

  11. Dimensional Anhedonia Rating Scale

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

    Measured: Week 32

  12. Antidepressant Side-Effect Checklist

    Evaluate the adverse reactions of patients after using antidepressants.

    Measured: Baseline

  13. Antidepressant Side-Effect Checklist

    Evaluate the adverse reactions of patients after using antidepressants.

    Measured: Week 4

  14. Antidepressant Side-Effect Checklist

    Evaluate the adverse reactions of patients after using antidepressants.

    Measured: Week 8

  15. Antidepressant Side-Effect Checklist

    Evaluate the adverse reactions of patients after using antidepressants.

    Measured: Week 16

  16. Antidepressant Side-Effect Checklist

    Evaluate the adverse reactions of patients after using antidepressants.

    Measured: Week 32

  17. Perceived deficits questionnaire

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

    Measured: Baseline

  18. Perceived deficits questionnaire

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

    Measured: Week 4

  19. Perceived deficits questionnaire

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

    Measured: Week 8

  20. Perceived deficits questionnaire

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

    Measured: Week 16

  21. Perceived deficits questionnaire

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

    Measured: Week 32

Secondary outcomes (15)

  1. Hamilton Anxiety Scale

    Assess the severity of the patient's anxiety symptoms.

    Measured: Baseline

  2. Hamilton Anxiety Scale

    Assess the severity of the patient's anxiety symptoms.

    Measured: Week 4

  3. Hamilton Anxiety Scale

    Assess the severity of the patient's anxiety symptoms.

    Measured: Week 8

  4. Hamilton Anxiety Scale

    Assess the severity of the patient's anxiety symptoms.

    Measured: Week 16

  5. Hamilton Anxiety Scale

    Assess the severity of the patient's anxiety symptoms.

    Measured: Week 32

  6. Pittsburgh sleep quality index

    Evaluate the patient's sleep quality within one month, including sleep effect and duration.

    Measured: Baseline

  7. Pittsburgh sleep quality index

    Evaluate the patient's sleep quality within one month, including sleep effect and duration.

    Measured: Week 4

  8. Pittsburgh sleep quality index

    Evaluate the patient's sleep quality within one month, including sleep effect and duration.

    Measured: Week 8

  9. Pittsburgh sleep quality index

    Evaluate the patient's sleep quality within one month, including sleep effect and duration.

    Measured: Week 16

  10. Pittsburgh sleep quality index

    Evaluate the patient's sleep quality within one month, including sleep effect and duration.

    Measured: Week 32

  11. Short-form 36 item health survey questionnaire

    Assess the patient's health and quality of life within one month

    Measured: Baseline

  12. Short-form 36 item health survey questionnaire

    Assess the patient's health and quality of life within one month

    Measured: Week 4

  13. Short-form 36 item health survey questionnaire

    Assess the patient's health and quality of life within one month

    Measured: Week 8

  14. Short-form 36 item health survey questionnaire

    Assess the patient's health and quality of life within one month

    Measured: Week 16

  15. Short-form 36 item health survey questionnaire

    Assess the patient's health and quality of life within one month

    Measured: Week 32

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Dec 2022
  2. Study start1 Jan 2023
  3. Primary completion31 Dec 2024
  4. Study completion31 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05669391
Sponsor's protocol ID
PWZxk2022-18
Status last verified
Jan 2023
First submitted
20 Dec 2022
Last updated
19 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 9915229

  • 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.

    PubMed 32780949

  • 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.

    PubMed 32529266

  • 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.

    PubMed 30677646

  • 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.

    PubMed 32629971

  • Luzum JA, Pakyz RE, Elsey AR, Haidar CE, Peterson JF, Whirl-Carrillo M, Handelman SK, Palmer K, Pulley JM, Beller M, Schildcrout JS, Field JR, Weitzel KW, Cooper-DeHoff RM, Cavallari LH, O'Donnell PH, Altman RB, Pereira N, Ratain MJ, Roden DM, Embi PJ, Sadee W, Klein TE, Johnson JA, Relling MV, Wang L, Weinshilboum RM, Shuldiner AR, Freimuth RR; Pharmacogenomics Research Network Translational Pharmacogenetics Program. The Pharmacogenomics Research Network Translational Pharmacogenetics Program: Outcomes and Metrics of Pharmacogenetic Implementations Across Diverse Healthcare Systems. Clin Pharmacol Ther. 2017 Sep;102(3):502-510. doi: 10.1002/cpt.630. Epub 2017 Jun 9.

    PubMed 28090649

  • Winner JG, Carhart JM, Altar CA, Allen JD, Dechairo BM. A prospective, randomized, double-blind study assessing the clinical impact of integrated pharmacogenomic testing for major depressive disorder. Discov Med. 2013 Nov;16(89):219-27.

    PubMed 24229738

  • 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.

    PubMed 30837874

  • 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.

    PubMed 28025020

  • 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.

    PubMed 28515818

  • Tong J, Yuan J, Qin Y, Zhu N, Zhang T, Zhu X, Xu Y, Liu M, Zhang J, Sun X. Clinicians' experience on the effectiveness of pharmacotherapy in patients with first-episode depression: a randomized controlled trial based on pharmacogenomics. Front Pharmacol. 2025 Aug 7;16:1626654. doi: 10.3389/fphar.2025.1626654. eCollection 2025.

    PubMed 40852613

Questions about this trial

What is this clinical trial studying?

A study testing Genomic analysis of antidepressants in people with Pharmacogenomics and Depression, run by Tongji University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Genomic analysis of antidepressants (time frame: Baseline). The study lists 21 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05669391, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2025.

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