Association of Peripheral Immune Cells With Antidepressant Treatment Response

NCT06182722 | Recruiting

• 1 other identifier: 2022-TX-010
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this observational study is discovering potential biomarkers to predict antidepressant treatment response in patients with major depressive disorder (MDD) while comparing the transcriptomic changes between patients with MDD and healthy controls as well as before and after antidepressant treatment. Eligible patients will be assessed at Week 1, Week 2, Week 4 and Week 8 while healthy normal volunteers will only be evaluated at baseline. Assessments will include the following: an interview about mental and physical health, a physical examination including drawing of venous blood samples and several psychiatric rating scales.

Conditions

Depressive Disorder; Genetic Change

Outcome Measures

Primary Outcomes (1)

• Change of HAMD-17 (Hamilton Depression Rating Scale) total score

  The overall score of HAMD-17 (Hamilton Depression Rating Scale) is 68 points. Primary outcome measures the change of HAMD-17 total score between baseline and week 8. Larger reduction in HAMD-17 represents better antidepressant treatment response.

  From baseline to Week 8

Secondary Outcomes (4)

• Effective rate measured by HAMD-17 (Hamilton Depression Rating Scale)

  From baseline to Week 8

• MADRS Effective rate measured by MADRS (Montgomery-Åsberg depression rating scale)

  From baseline to Week 8

• Remission rate measured by HAMD-17 (Hamilton Depression Rating Scale)

  From baseline to Week 8

• MADRS Remission rate measured by MADRS (Montgomery-Åsberg depression rating scale)

  From baseline to Week 8

Other Outcomes (4)

• HAMD-17 (Hamilton Depression Rating Scale) total score

  Baseline, Week 2, Week 4 and Week 8.

• MADRS (Montgomery-Åsberg depression rating scale) total score

  Baseline, Week 2, Week 4 and Week 8.

• CGI-S (Clinical Gloabl Impression-Severity) score

  Baseline, Week 2, Week 4 and Week 8.

Study Arms (2)

Major Depressive Disorder (MDD)

Patients with major depressive disorder. These patients consisted of two cohorts. The first cohort is expected to consist of 15 participants for nested cohort study. The rest form the second cohort.

Diagnostic Test: Mental assessments

Healthy controls

Healthy normal volunteers.

Interventions

Mental assessments DIAGNOSTIC_TEST

Patients will receive psychiatric rating scales evaluation every visit.

Also known as: Psychiatric rating scales

Major Depressive Disorder (MDD)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Outpatients/inpatients who meet DSM-5 diagnostic criteria of current or past major depressive disorder and are going to receive SSRIs or SNRIs monotherapy.

You may qualify if:

• Age 18-65 years old, regardless of gender;
• The subject is an outpatient/inpatient and meets DSM-5 diagnostic criteria of current or past major depressive disorder;
• SSRIs or SNRIs monotherapy;
• HAMD-17 total score ≥ 18 at baseline;
• The subject can read and write and is capable of giving informed consent.

You may not qualify if:

• Patients with mental illness other than MDD;
• Patients with liver and kidney diseases, cardiovascular system diseases, cancer, diabetes, thyroid diseases or other serious or unstable conditions;
• Previous organic brain disease, traumatic brain injury or other diseases that can cause structural brain changes;
• Serious abnormalities indicated by laboratory tests or electrocardiograms;
• Alcohol or drug addiction;
• Suffering from systemic lupus erythematosus, multiple sclerosis or other autoimmune diseases;
• Patients who are taking drugs that directly impact on the immune system such as anti-inflammatory drugs or immunosuppressants;
• Patients who have taken antidepressants or other antipsychotics within 2 weeks before enrollment;
• Patients who have received MECT or systematic psychotherapy within 3 months before enrollment;
• Patients at high risk of suicide, or reporting a HAMD-17 item 3 (suicide item) score \>3 at baseline;
• Subjects who are pregnant or lactating;
• Other conditions that are considered not suitable for participating in the research.

Sponsors & Collaborators

• Shanghai Mental Health Center: lead

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

Related Publications (6)

• Malhi GS, Mann JJ. Depression. Lancet. 2018 Nov 24;392(10161):2299-2312. doi: 10.1016/S0140-6736(18)31948-2. Epub 2018 Nov 2.

  PMID: 30396512 BACKGROUND

• Kato T, Furukawa TA, Mantani A, Kurata K, Kubouchi H, Hirota S, Sato H, Sugishita K, Chino B, Itoh K, Ikeda Y, Shinagawa Y, Kondo M, Okamoto Y, Fujita H, Suga M, Yasumoto S, Tsujino N, Inoue T, Fujise N, Akechi T, Yamada M, Shimodera S, Watanabe N, Inagaki M, Miki K, Ogawa Y, Takeshima N, Hayasaka Y, Tajika A, Shinohara K, Yonemoto N, Tanaka S, Zhou Q, Guyatt GH; SUN☺D Investigators. Optimising first- and second-line treatment strategies for untreated major depressive disorder - the SUN☺D study: a pragmatic, multi-centre, assessor-blinded randomised controlled trial. BMC Med. 2018 Jul 11;16(1):103. doi: 10.1186/s12916-018-1096-5.

  PMID: 29991347 BACKGROUND

• Leday GGR, Vertes PE, Richardson S, Greene JR, Regan T, Khan S, Henderson R, Freeman TC, Pariante CM, Harrison NA; MRC Immunopsychiatry Consortium; Perry VH, Drevets WC, Wittenberg GM, Bullmore ET. Replicable and Coupled Changes in Innate and Adaptive Immune Gene Expression in Two Case-Control Studies of Blood Microarrays in Major Depressive Disorder. Biol Psychiatry. 2018 Jan 1;83(1):70-80. doi: 10.1016/j.biopsych.2017.01.021. Epub 2017 Jul 6.

  PMID: 28688579 BACKGROUND

• Nohr AK, Lindow M, Forsingdal A, Demharter S, Nielsen T, Buller R, Moltke I, Vitezic M, Albrechtsen A. A large-scale genome-wide gene expression analysis in peripheral blood identifies very few differentially expressed genes related to antidepressant treatment and response in patients with major depressive disorder. Neuropsychopharmacology. 2021 Jun;46(7):1324-1332. doi: 10.1038/s41386-021-01002-9. Epub 2021 Apr 8.

  PMID: 33833401 BACKGROUND

• Cattaneo A, Ferrari C, Turner L, Mariani N, Enache D, Hastings C, Kose M, Lombardo G, McLaughlin AP, Nettis MA, Nikkheslat N, Sforzini L, Worrell C, Zajkowska Z, Cattane N, Lopizzo N, Mazzelli M, Pointon L, Cowen PJ, Cavanagh J, Harrison NA, de Boer P, Jones D, Drevets WC, Mondelli V, Bullmore ET; Neuroimmunology of Mood Disorders and Alzheimer's Disease (NIMA) Consortium; Pariante CM. Whole-blood expression of inflammasome- and glucocorticoid-related mRNAs correctly separates treatment-resistant depressed patients from drug-free and responsive patients in the BIODEP study. Transl Psychiatry. 2020 Jul 23;10(1):232. doi: 10.1038/s41398-020-00874-7.

  PMID: 32699209 BACKGROUND

• Zheng C, Zheng L, Yoo JK, Guo H, Zhang Y, Guo X, Kang B, Hu R, Huang JY, Zhang Q, Liu Z, Dong M, Hu X, Ouyang W, Peng J, Zhang Z. Landscape of Infiltrating T Cells in Liver Cancer Revealed by Single-Cell Sequencing. Cell. 2017 Jun 15;169(7):1342-1356.e16. doi: 10.1016/j.cell.2017.05.035.

  PMID: 28622514 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood samples

MeSH Terms

Conditions

Depressive Disorder

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders

Study Officials

• Shen He

  Shanghai Mental Health Center

  STUDY DIRECTOR

Central Study Contacts

Huangfang Li

CONTACT

+86-2134773128; lihuafang@smhc.org.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 16, 2023
• First Posted: December 27, 2023
• Study Start: March 13, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 9, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)