Status:
UNKNOWN
Optimization of Diagnosis and Treatment of Depression Based on Multidimensional Clinical Assessment Classification
Lead Sponsor:
Shanghai Mental Health Center
Collaborating Sponsors:
RenJi Hospital
Shanghai 10th People's Hospital
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
Major depressive disorder (MDD) characterized by high prevalence, high recurrence rate and high disability rate is a mental illness with the heaviest burden and has become a major public health issue ...
Eligibility Criteria
Inclusion
- 18-60 years old;
- Meeting with the criteria of major depressive disorder in the Diagnostic and Statistical Manual of Mental Disorders (DSM)-5;
- Scored 20 or higher on the Hamilton's Depression Scale with 24 items (HAMD-24);
- With enough audio-visual ability and comprehensive ability to accomplish the visits;
- No medication or washout period of at least 2 weeks
- Scored less than 14 on the Hypomania Symptom Checklist-32 (HCL-32);
Exclusion
- Existing serious and active physical diseases that may interfere with treatment (abnormal indicators\> 2 times the normal value), or there is a pharmacological conflict between the current medical medication and the study drug;
- Previous mania or hypomania episodes;
- Female patients who are pregnant, planning to be pregnant or breastfeeding;
- Current high suicide risk (e.g. 3rd item of HAMD-24 scored≥3(suicidality));
- Had ECT, MECT or rTMS in the past 6 months;
- Experienced a history of dependence on psychoactive substances, organic mental disorders, personality disorders, mental retardation, neurodegenerative diseases, brain trauma and cerebrovascular diseases.
Key Trial Info
Start Date :
October 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2022
Estimated Enrollment :
960 Patients enrolled
Trial Details
Trial ID
NCT04528628
Start Date
October 1 2020
End Date
September 1 2022
Last Update
August 27 2020
Active Locations (4)
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1
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
2
Med-X Research Institute of Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, China
3
Renji Hospital of Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
4
Shanghai Tenth People's Hospital, Tongji University
Shanghai, Shanghai Municipality, China