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Optimization of Diagnosis and Treatment of Depression Based on Multidimensional Clinical Assessment Classification

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04528628
Recruitment Status : Not yet recruiting
First Posted : August 27, 2020
Last Update Posted : August 27, 2020
Sponsor:
Collaborators:
RenJi Hospital
Shanghai 10th People's Hospital
Huashan Hospital
Shanghai Jiao Tong University School of Medicine
Nanjing Medical University
Zhejiang University
Information provided by (Responsible Party):
Shanghai Mental Health Center

Study Description
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: SSRIs/SNRIs (Selective Serotonin Reuptake Inhibitors/ Serotonin and Norepinephrine Reuptake Inhibitors) Drug: Treatment as Usual Combination Product: SSRIs/SNRIs (Selective Serotonin Reuptake Inhibitors/ Serotonin and Norepinephrine Reuptake Inhibitors) Combined with Magnetic Stimulations Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 960 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Optimization of Diagnosis and Treatment of Depression Based on Multidimensional Clinical Assessment Classification
Estimated Study Start Date : October 2020
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Serotonin

Arms and Interventions
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Arm Intervention/treatment
Experimental: MDD with melancholic features Drug: SSRIs/SNRIs (Selective Serotonin Reuptake Inhibitors/ Serotonin and Norepinephrine Reuptake Inhibitors)
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.

Drug: Treatment as Usual
The research doctor discusses the treatment plan with the patient, and therapies and drugs are not limited.

Combination Product: SSRIs/SNRIs (Selective Serotonin Reuptake Inhibitors/ Serotonin and Norepinephrine Reuptake Inhibitors) Combined with Magnetic Stimulations
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.
Experimental: MDD with atypical features Drug: SSRIs/SNRIs (Selective Serotonin Reuptake Inhibitors/ Serotonin and Norepinephrine Reuptake Inhibitors)
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.

Drug: Treatment as Usual
The research doctor discusses the treatment plan with the patient, and therapies and drugs are not limited.

Combination Product: SSRIs/SNRIs (Selective Serotonin Reuptake Inhibitors/ Serotonin and Norepinephrine Reuptake Inhibitors) Combined with Magnetic Stimulations
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.
Experimental: MDD with anxious distress Drug: SSRIs/SNRIs (Selective Serotonin Reuptake Inhibitors/ Serotonin and Norepinephrine Reuptake Inhibitors)
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.

Drug: Treatment as Usual
The research doctor discusses the treatment plan with the patient, and therapies and drugs are not limited.

Combination Product: SSRIs/SNRIs (Selective Serotonin Reuptake Inhibitors/ Serotonin and Norepinephrine Reuptake Inhibitors) Combined with Magnetic Stimulations
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.
Experimental: MDD (overall) Drug: SSRIs/SNRIs (Selective Serotonin Reuptake Inhibitors/ Serotonin and Norepinephrine Reuptake Inhibitors)
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.

Drug: Treatment as Usual
The research doctor discusses the treatment plan with the patient, and therapies and drugs are not limited.

Combination Product: SSRIs/SNRIs (Selective Serotonin Reuptake Inhibitors/ Serotonin and Norepinephrine Reuptake Inhibitors) Combined with Magnetic Stimulations
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.


Outcome Measures
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Primary Outcome Measures :
  1. remission of acute phase [ Time Frame: 12 weeks ]
    scored 7 or lower on the Hamilton's Depression Scale with 24 items


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 18-60 years old;
  2. Meeting with the criteria of major depressive disorder in the Diagnostic and Statistical Manual of Mental Disorders (DSM)-5;
  3. Scored 20 or higher on the Hamilton's Depression Scale with 24 items (HAMD-24);
  4. With enough audio-visual ability and comprehensive ability to accomplish the visits;
  5. No medication or washout period of at least 2 weeks
  6. Scored less than 14 on the Hypomania Symptom Checklist-32 (HCL-32);

Exclusion Criteria:

  1. 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;
  2. Previous mania or hypomania episodes;
  3. Female patients who are pregnant, planning to be pregnant or breastfeeding;
  4. Current high suicide risk (e.g. 3rd item of HAMD-24 scored≥3(suicidality));
  5. Had ECT, MECT or rTMS in the past 6 months;
  6. Experienced a history of dependence on psychoactive substances, organic mental disorders, personality disorders, mental retardation, neurodegenerative diseases, brain trauma and cerebrovascular diseases.
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04528628


Contacts
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Contact: Daihui Peng, MD. PhD. 18017311136 pdhsh@126.com

Locations
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China, Shanghai
Huashan Hospital, Fudan University
Shanghai, Shanghai, China
Contact: Yiyun Cai         
Med-X Research Institute of Shanghai Jiao Tong University
Shanghai, Shanghai, China
Renji Hospital of Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai, China
Contact: Yanli Luo         
Shanghai Tenth People's Hospital, Tongji University
Shanghai, Shanghai, China
Contact: Yuan Shen         
Sponsors and Collaborators
Shanghai Mental Health Center
RenJi Hospital
Shanghai 10th People's Hospital
Huashan Hospital
Shanghai Jiao Tong University School of Medicine
Nanjing Medical University
Zhejiang University
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Shanghai Mental Health Center
ClinicalTrials.gov Identifier: NCT04528628    
Other Study ID Numbers: SHZD2020PDH
First Posted: August 27, 2020    Key Record Dates
Last Update Posted: August 27, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Norepinephrine
Serotonin
Serotonin Uptake Inhibitors
Serotonin and Noradrenaline Reuptake Inhibitors
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
 Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators