Optimization of Diagnosis and Treatment of Depression Based on Multidimensional Clinical Assessment Classification
1 other identifier
interventional
960
1 country
4
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 in China and the world. Great challenges in diagnosis and treatment of depression consist of the complicated pathogenesis, a lack of objective diagnostic criteria, unsatisfactory treatment outcomes and poor treatment compliance. The previous studies of our research team showed that depression is affected by multiple factors. We could explore important markers for the diagnosis, treatment and prediction of treatment efficacy in depressed patients' data collected from different dimensions including immunometabolism, brain electrophysiology, brain structure and functional neural circuits, neuropsychology and psychophysiology. Our completed studies in the National Science and Technology Support Program and National Key Research and Development (R\&D) Program of the 12th and 13th Five-Year Plan in China found that treatment designed for specific clinical subtypes can improve the treatment effect, and meanwhile, the application of electronic-measurement based care (e-MBC) combined with smart mobile terminals can effectively provide whole-course medical management for patients, improve patient compliance and increase the efficacy of clinical diagnosis and treatment. However, due to disease diagnosis based on clinical symptomatology without subtype distinction and lack of multi-scale biological data mining, multidimensional assessment and deep integration, the results of most previous studies can hardly be used in clinical practice. Therefore, there is a strong urge to carry out a systematic research in which multidimensional evaluation of clinical characteristics and a large scale of data collection and mining are needed to form clinical diagnosis and optimal treatment regimens for depression subtypes. To achieve the goal, patients with depression will be our research subject in this study. First, on the basis of the previous cohort study and the whole-course e-MBC, patients' data of movement, respiratory rate, heart rate and sleep will be further collected. With the help of artificial intelligence (AI) technology such as deep machine learning, the data integrated with EEG imaging and specific immunometabolic markers in blood will be analyzed with clinical characteristics. The model of diagnosis and classification will be established based on multidimensional clinical assessment and verified. Second, through a prospective multicenter randomized controlled trial, optimal treatment regimens for different depression subtypes and individualized magnetic stimulation physical intervention technology navigated by AI will be explored so as to establish a predictive model of curative effect. Finally, long-term follow-up and its regular data collection can be completed on the patient diagnosis and treatment platform which is linked to the e-MBC. Thus, a stable clinical cohort and an advanced database containing multidimensional information of depression will be set up. The whole course e-MBC management platform will be optimized and promoted to improve patient compliance, treatment efficiency and prognosis. This study can provide evidence for precise diagnosis and classification of depression and optimal treatment regimens for different subtypes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable major-depressive-disorder
Started Oct 2020
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 24, 2020
CompletedFirst Posted
Study publicly available on registry
August 27, 2020
CompletedStudy Start
First participant enrolled
October 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2022
CompletedAugust 27, 2020
August 1, 2020
1.9 years
August 24, 2020
August 24, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
remission of acute phase
scored 7 or lower on the Hamilton's Depression Scale with 24 items
12 weeks
Study Arms (4)
MDD with melancholic features
EXPERIMENTALMDD with atypical features
EXPERIMENTALMDD with anxious distress
EXPERIMENTALMDD (overall)
EXPERIMENTALInterventions
Patients will be treated with one kind of selective serotonin reuptake inhibitors/ serotonin and norepinephrine reuptake inhibitors. Dose is titrated to the minimum effective dose within 2 weeks. Benzodiazepines can be used for a short period lasting no more than 2 weeks.
The research doctor discusses the treatment plan with the patient, and therapies and drugs are not limited.
Drug therapies are the same as the SSRIs/SNRIs monotherapy group. Patients will randomly receive one kind of magnetic stimulations including repetitive transcranial magnetic stimulation (rTMS), continuous theta burst stimulation(cTBS) and intermittent theta burst stimulation (iTBS) at a ratio of 1:1:1.
Eligibility Criteria
You may qualify if:
- 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);
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shanghai Mental Health Centerlead
- RenJi Hospitalcollaborator
- Shanghai 10th People's Hospitalcollaborator
- Huashan Hospitalcollaborator
- Shanghai Jiao Tong University School of Medicinecollaborator
- Nanjing Medical Universitycollaborator
- Zhejiang Universitycollaborator
Study Sites (4)
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Med-X Research Institute of Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, China
Renji Hospital of Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Shanghai Tenth People's Hospital, Tongji University
Shanghai, Shanghai Municipality, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 24, 2020
First Posted
August 27, 2020
Study Start
October 1, 2020
Primary Completion
September 1, 2022
Study Completion
September 1, 2022
Last Updated
August 27, 2020
Record last verified: 2020-08