Major Depressive DisorderNCT04518592
Model-based Defining of Subtypes of Depression and Optimal Treatment: an Integrated Techniques Module.
An observational study of Major Depressive Disorder, run by Shanghai Mental Health Center at 1 site in China.
Trial summary
In this proposal, the investigators aim to explore the clinical subtypes and biological markers to personalize the use of antidepressants in MDD. By stratifying the subjects with (versus without) remission and treatment response, the biological markers are expected to have important prediction effects in future… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 22 Dec 2020to 30 Sep 2024
- 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: Enrollment is constrained to those participants dosed with SSRI/SNRI and healthy controls.
Who may be able to join
- Male or female subjects aged 18-65 years, outpatients or inpatients.
- Meets the DSM-V criteria for Severe Major Depressive Disorder ; a single episode（296.21、296.22、296.23）or recurrent episode （296.31、296.32、296.33）；
- MADRS score greater than or equal to 24 in baseline；
- HAMD-17 score greater than or equal to 20 in baseline.
- Patients have learned and voluntarily participated in the study, and have to sign informed consent.
Who cannot join
- Meets the DSM-V criteria for other mental disorder(schizophrenia spectrum and other psychotic disorders, bipolar and related disorders, anxiety disorders, obsessive-compulsive and related disorders, somatic symptom and related disorders, etc ).
- Patient has survived suicide attempt , or may have a significant risk for suicidal behavior ,or with a score of >3 on suicidal thoughts item 10 on the MADRS.
- Depressive episode of an organic mental disorder secondary to a systemic disease or a central nervous system disease, such as depressive episode secondary to hypothyroidism.
- Serious and instable body disease such as cerebrovascular disease, respiratory disease, blood disease, liver and kidney disease, disease of internal secretion, nervous system and other systemic disease.
- any history of seizures or other organic brain diseases.
- History of alcohol or drug abuse (besides nicotine) over the last 6 months
Show all 12Show fewer
- Serious and instable body disease such as cerebrovascular disease, liver and kidney disease, disease of internal secretion (abnormal thyroid function), blood disease; any history of seizures or other organic brain diseases.
- Subjects who can't take drug or have an operation history which affect drug metabolism.
- Clinically significant changes in ECG or laboratory tests, including >1.5X upper limit of normal liver function、over the limit of normal renal function and blood sugar、abnormal cardiac troponins、obvious abnormity in the thyroid function
- Pregnant or lactating women and women of childbearing potential throughout the study period; men who have the desire of fertility within three months;
- Participation in other clinical studies in the nearly 1 month before screen.
- Other conditions which, in the investigator's judgment, render patients unsuitable for the clinical study.
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
Official title: Model-based Defining of Subtypes of Depression and Optimal Treatment: an Integrated Techniques Module in Multidimensional Omics for Peripheral Biomarkers.
In this proposal, the investigators aim to explore the clinical subtypes and biological markers to personalize the use of antidepressants in MDD. By stratifying the subjects with (versus without) remission and treatment response, the biological markers are expected to have important prediction effects in future clinical practice.
Read the detailed description
In this proposal, through the integration of genome, transcriptome, protein, metabolic group, microbial group and immune cell subtype of multidimensional omics data to construct the curative effect of forecast model.The investigators aim to explore the clinical subtypes and biological markers to personalize the use of antidepressants in MDD. By stratifying the subjects with (versus without) remission and treatment response, the biological markers are expected to have important prediction effects in future clinical practice.Ultimate aim is to solve the depression medication selection dilemma of "trial and error", reduce medical costs, improving depression treatment experience.
- Conditions
- Major Depressive Disorder
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Severe Major Depressive Disorder | subjects who meet the standards;using conventional antidepressant. | |
| control , healthy | subjects who meet the standards;gender, race, and level of education matched healthy people |
What is being measured
The primary outcome is the main question the study is designed to answer.
reductive scores of Montgomery-Asberg Depression Rating Scale(MADRS)
change in MADRS scores from baseline and week 8
Measured: assess the scale at baseline and week 8.
Secondary outcomes (9)
effective rate
ratio of points of Montgomery-Asberg Depression Rating Scale(MADRS) and/or Hamilton Depression Scale-17(HAMD-17)
Measured: assess the scale at baseline and week 8.
Response rate
Montgomery-Asberg Depression Rating Scale(MADRS) ≤ 10 and/or Hamilton Depression Scale-17(HAMD-17) ≤7
Measured: assess the scale at baseline and week 8.
Montgomery-Asberg Depression Rating Scale(MADRS) scores
Montgomery-Asberg Depression Rating Scale(MADRS) scores at baseline and week 4, 8
Measured: assess the scale at baseline and week 4, 8.
Subtraction score
Hamilton Depression Scale-17(HAMD17) total score after 8 weeks treatment compared with the baseline subtraction score.
Measured: assess the scale at baseline and week 4, 8.
The overall evaluation of illness
the CGI-s (Clinical Global Impression scale - Severity of Illness)rating changes compared to the baseline and CGI - I score.
Measured: assess the scale at baseline and week 4, 8.
Hamilton Anxiety Scale
the scores changes compared to the baseline
Measured: assess the scale at baseline and week 4, 8.
The Pittsburgh Sleep Quality Index
the scores changes compared to the baseline
Measured: assess the scale at baseline and week 4, 8.
The Montreal Cognitive Assessment
the scores changes compared to the baseline
Measured: assess the scale at baseline and week 4, 8.
The Quick Inventory of Depressive Symptomatology (16-Item) (Self-Report)
the scores changes compared to the baseline
Measured: assess the scale at baseline and week 4, 8.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2020
- Study start22 Dec 2020
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Major 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- huafang Li, Phd, Study chair, Study Principal Investigator Drug Clinical Trial Office, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04518592
- Sponsor's protocol ID
- MDSDOT
- Status last verified
- Apr 2024
- First submitted
- 16 Aug 2020
- Last updated
- 24 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zheng Y, Zeng D, Tian Y, Li S, He S, Li H. A network-based approach to discover diagnostic metabolite markers associated with depressive features for major depressive disorder. Front Psychiatry. 2025 Jun 6;16:1610520. doi: 10.3389/fpsyt.2025.1610520. eCollection 2025.
PubMed 40547126Zheng Y, Zhang L, He S, Xie Z, Zhang J, Ge C, Sun G, Huang J, Li H. Integrated Module of Multidimensional Omics for Peripheral Biomarkers (iMORE) in patients with major depressive disorder: rationale and design of a prospective multicentre cohort study. BMJ Open. 2022 Nov 23;12(11):e067447. doi: 10.1136/bmjopen-2022-067447.
PubMed 36418119
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Model-based Defining of Subtypes of Depression and Optimal Treatment: an Integrated Techniques Module in Multidimensional Omics for Peripheral Biomarkers.
- ClinicalTrials.gov ID
- NCT04518592
- Acronym / sponsor ID
- MDSDOT
- Conditions
- Major Depressive Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- 22 Dec 2020 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 19 Aug 2020 (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.
In this proposal, the investigators aim to explore the clinical subtypes and biological markers to personalize the use of antidepressants in MDD. By stratifying the subjects with (versus without) remission and treatment response, the biological markers are expected to have important prediction effects in future clinical practice.
Detailed description
In this proposal, through the integration of genome, transcriptome, protein, metabolic group, microbial group and immune cell subtype of multidimensional omics data to construct the curative effect of forecast model.The investigators aim to explore the clinical subtypes and biological markers to personalize the use of antidepressants in MDD. By stratifying the subjects with (versus without) remission and treatment response, the biological markers are expected to have important prediction effects in future clinical practice.Ultimate aim is to solve the depression medication selection dilemma of "trial and error", reduce medical costs, improving depression treatment experience.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Severe Major Depressive Disorder | – | –subjects who meet the standards;using conventional antidepressant. |
| control , healthy | – | –subjects who meet the standards;gender, race, and level of education matched healthy people |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Enrollment is constrained to those participants dosed with SSRI/SNRI and healthy controls.
Key inclusion criteria (5 listed)
- Male or female subjects aged 18-65 years, outpatients or inpatients.
- Meets the DSM-V criteria for Severe Major Depressive Disorder ; a single episode（296.21、296.22、296.23）or recurrent episode （296.31、296.32、296.33）；
- MADRS score greater than or equal to 24 in baseline；
- HAMD-17 score greater than or equal to 20 in baseline.
- Patients have learned and voluntarily participated in the study, and have to sign informed consent.
Key exclusion criteria (12 listed)
- Meets the DSM-V criteria for other mental disorder(schizophrenia spectrum and other psychotic disorders, bipolar and related disorders, anxiety disorders, obsessive-compulsive and related disorders, somatic symptom and related disorders, etc ).
- Patient has survived suicide attempt , or may have a significant risk for suicidal behavior ,or with a score of >3 on suicidal thoughts item 10 on the MADRS.
- Depressive episode of an organic mental disorder secondary to a systemic disease or a central nervous system disease, such as depressive episode secondary to hypothyroidism.
- Serious and instable body disease such as cerebrovascular disease, respiratory disease, blood disease, liver and kidney disease, disease of internal secretion, nervous system and other systemic disease.
- any history of seizures or other organic brain diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
reductive scores of Montgomery-Asberg Depression Rating Scale(MADRS)
Time frame: assess the scale at baseline and week 8.
change in MADRS scores from baseline and week 8
9 secondary outcomes
effective rate
Time frame: assess the scale at baseline and week 8.
Response rate
Time frame: assess the scale at baseline and week 8.
Montgomery-Asberg Depression Rating Scale(MADRS) scores
Time frame: assess the scale at baseline and week 4, 8.
Subtraction score
Time frame: assess the scale at baseline and week 4, 8.
The overall evaluation of illness
Time frame: assess the scale at baseline and week 4, 8.
Hamilton Anxiety Scale
Time frame: assess the scale at baseline and week 4, 8.
The Pittsburgh Sleep Quality Index
Time frame: assess the scale at baseline and week 4, 8.
The Montreal Cognitive Assessment
Time frame: assess the scale at baseline and week 4, 8.
The Quick Inventory of Depressive Symptomatology (16-Item) (Self-Report)
Time frame: assess the scale at baseline and week 4, 8.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
- Derived from this study: PubMed 40547126Zheng Y, Zeng D, Tian Y, Li S, He S, Li H. A network-based approach to discover diagnostic metabolite markers associated with depressive features for major depressive disorder. Front Psychiatry. 2025 Jun 6;16:1610520. doi: 10.3389/fpsyt.2025.1610520. eCollection 2025.
- Derived from this study: PubMed 36418119Zheng Y, Zhang L, He S, Xie Z, Zhang J, Ge C, Sun G, Huang J, Li H. Integrated Module of Multidimensional Omics for Peripheral Biomarkers (iMORE) in patients with major depressive disorder: rationale and design of a prospective multicentre cohort study. BMJ Open. 2022 Nov 23;12(11):e067447. doi: 10.1136/bmjopen-2022-067447.
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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.
huafang Li, Phd study chair
Study Principal Investigator Drug Clinical Trial Office, 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 Major Depressive Disorder, 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 24 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 huafang Li, Phd (86-21-64387250 ext. 3128, lhlh_5@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reductive scores of Montgomery-Asberg Depression Rating Scale(MADRS) (time frame: assess the scale at baseline and 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 NCT04518592, which also lists 2 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 24 Apr 2024.