Depressive DisorderNCT06182722
Association of Peripheral Immune Cells With Antidepressant Treatment Response
An observational study of Depressive Disorder and Genetic Change, run by Shanghai Mental Health Center at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Depressive Disorder, Genetic Change
- What is being tested?
- Mental assessments
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 13 Mar 2024to Dec 2025
- How long will I take part?
- 2 Months
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030
Huafang Li, PH.D, 86-2134773128, lhlh_5@163.com
About this study
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.
Read the detailed description
This study is focusing on evaluating the peripheral immune system of major depressive disorder (MDD) and the impact of antidepressants treatment. Single-cell RNA sequencing and single-cell VDJ sequencing will be performed on peripheral blood mononuclear cells to collect transcriptome information and immune repertoire of peripheral blood in patients with MDD. Bulk RNA sequencing and flow cytometry will be used to validate the clinical value of results.
This is a biomarker study (antidepressants); treatment will be carried out according to physicians' orders.
- Conditions
- Depressive Disorder, Genetic Change
- Being tested
- Mental assessments
- Medical subject headings
- Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mental assessmentsDiagnostic test
Also called Psychiatric rating scales
Patients will receive psychiatric rating scales evaluation every visit.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Mental assessments | |
| Healthy controls | Healthy normal volunteers. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline to Week 8
Secondary outcomes (4)
Effective rate measured by HAMD-17 (Hamilton Depression Rating Scale)
A reduction of 50% or more in the HAMD-17 (Hamilton Depression Rating Scale) total score. More patients with a reduction of 50% or more indicates better effectiveness. Minimun value of HAMD-17 is 0 and maximum value of HAMD-17 is 68 points.
Measured: From baseline to Week 8
MADRS Effective rate measured by MADRS (Montgomery-Åsberg depression rating scale)
A reduction of 50% or more in the MADRS (Montgomery-Åsberg depression rating scale) total score. More patients with a reduction of 50% or more indicates better effectiveness. Minimun value of MADRS is 0 and maximum value of MADRS is 60 points.
Measured: From baseline to Week 8
Remission rate measured by HAMD-17 (Hamilton Depression Rating Scale)
HAMD-17 (Hamilton Depression Rating Scale) total score ≤10 at week8. Lower total score of HAMD-17 at week 8 indicates better outcome. Minimun value of HAMD-17 is 0 and maximum value of HAMD-17 is 68 points.
Measured: From baseline to Week 8
MADRS Remission rate measured by MADRS (Montgomery-Åsberg depression rating scale)
MADRS (Montgomery-Åsberg depression rating scale) total score ≤7 at week8. Lower total score of HAMD-17 at week 8 indicates better outcome. Minimun value of MADRS is 0 and maximum value of MADRS is 60 points.
Measured: From baseline to Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2023
- Study start13 Mar 2024
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Shanghai Mental Health CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LI, Huafang, Shanghai Mental Health Center
- Investigators
- Shen He, Study director, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06182722
- Sponsor's protocol ID
- 2022-TX-010
- Status last verified
- Apr 2024
- First submitted
- 16 Sep 2023
- Last updated
- 9 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share IPD.
Publications
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.
PubMed 30396512Kato 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.
PubMed 29991347Leday 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.
PubMed 28688579Nohr 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.
PubMed 33833401Cattaneo 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.
PubMed 32699209Zheng 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.
PubMed 28622514
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Peripheral Immune Cells With Antidepressant Treatment Response
- ClinicalTrials.gov ID
- NCT06182722
- Acronym / sponsor ID
- 2022-TX-010
- Conditions
- Depressive Disorder, Genetic Change
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- 13 Mar 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 27 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is focusing on evaluating the peripheral immune system of major depressive disorder (MDD) and the impact of antidepressants treatment. Single-cell RNA sequencing and single-cell VDJ sequencing will be performed on peripheral blood mononuclear cells to collect transcriptome information and immune repertoire of peripheral blood in patients with MDD. Bulk RNA sequencing and flow cytometry will be used to validate the clinical value of results.
This is a biomarker study (antidepressants); treatment will be carried out according to physicians' orders.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Major Depressive Disorder (MDD) | – | Diagnostic Test: Mental assessmentsPatients 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. |
| Healthy controls | – | –Healthy normal volunteers. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mental assessmentsAlso: Psychiatric rating scalesPatients will receive psychiatric rating scales evaluation every visit. | Diagnostic test | Major Depressive Disorder (MDD) |
Primary outcome
Change of HAMD-17 (Hamilton Depression Rating Scale) total score
Time frame: From baseline to Week 8
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.
4 secondary outcomes
Effective rate measured by HAMD-17 (Hamilton Depression Rating Scale)
Time frame: From baseline to Week 8
MADRS Effective rate measured by MADRS (Montgomery-Åsberg depression rating scale)
Time frame: From baseline to Week 8
Remission rate measured by HAMD-17 (Hamilton Depression Rating Scale)
Time frame: From baseline to Week 8
MADRS Remission rate measured by MADRS (Montgomery-Åsberg depression rating scale)
Time frame: From baseline to Week 8
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.
- Background: PubMed 30396512Malhi GS, Mann JJ. Depression. Lancet. 2018 Nov 24;392(10161):2299-2312. doi: 10.1016/S0140-6736(18)31948-2. Epub 2018 Nov 2.
- Background: PubMed 29991347Kato 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.
- Background: PubMed 28688579Leday 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.
- Background: PubMed 33833401Nohr 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.
- Background: PubMed 32699209Cattaneo 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.
- Background: PubMed 28622514Zheng 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.
- Individual participant dataSharing planned: No. There is no plan to share IPD.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shen He study director
Shanghai Mental Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depressive Disorder and Genetic Change, run by Shanghai Mental Health Center 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 5 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 9 Apr 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Huangfang Li (+86-2134773128, lihuafang@smhc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of HAMD-17 (Hamilton Depression Rating Scale) total score (time frame: From baseline to Week 8). 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 NCT06182722, which also lists 6 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 9 Apr 2024.