- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04518592
Model-based Defining of Subtypes of Depression and Optimal Treatment: an Integrated Techniques Module in Multidimensional Omics for Peripheral Biomarkers.
August 18, 2020 updated by: Shanghai Mental Health Center
In this proposal, the investigators aim to explore the clinical subtypes and biological markers to personalize the use 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.
Study Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
300
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: huafang Li, Phd
- Phone Number: 3128 86-21-64387250
- Email: lhlh_5@163.com
Study Locations
-
-
Shanghai
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Shanghai, Shanghai, China, 200030
- Shanghai Mental Health Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Enrollment is constrained to those participants dosed with SSRI/SNRI and healthy controls.
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Severe Major Depressive Disorder
|
control , healthy
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
reductive ratio of HAMD-17
Time Frame: assess the scale at baseline and week 4, 8.
|
assess the scale at baseline and week 4, 8.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Montgomery-Asberg Depression Rating Scale (MADRS).
Time Frame: assess the scale at baseline and week 4, 8.
|
assess the scale at baseline and week 4, 8.
|
HAMILTON ANXIETY SCALE (HAMA)
Time Frame: assess the scale at baseline and week 4, 8.
|
assess the scale at baseline and week 4, 8.
|
Clinical Global Impression scale - Severity of Illness (CGI-S)
Time Frame: assess the scale at baseline and week 4, 8.
|
assess the scale at baseline and week 4, 8.
|
The Pittsburgh Sleep Quality Index (PSQI)
Time Frame: assess the scale at baseline and week 4, 8.
|
assess the scale at baseline and week 4, 8.
|
The Montreal Cognitive Assessment (MoCA), score
Time Frame: assess the scale at baseline and week 4, 8.
|
assess the scale at baseline and week 4, 8.
|
The Quick Inventory of Depressive Symptomatology (16-Item) (Self-Report) (QIDS-SR16)
Time Frame: assess the scale at baseline and week 4, 8.
|
assess the scale at baseline and week 4, 8.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: huafang Li, Phd, Study Principal Investigator Drug Clinical Trial Office, Shanghai Mental Health Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
September 1, 2020
Primary Completion (ANTICIPATED)
August 31, 2022
Study Completion (ANTICIPATED)
August 31, 2022
Study Registration Dates
First Submitted
August 16, 2020
First Submitted That Met QC Criteria
August 18, 2020
First Posted (ACTUAL)
August 19, 2020
Study Record Updates
Last Update Posted (ACTUAL)
August 19, 2020
Last Update Submitted That Met QC Criteria
August 18, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MDSDOT
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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