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

NCT ID: NCT04528628

Last Updated: 2020-08-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 960 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-31
• Study Completion Date: 2022-09-30

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.

Conditions

Major Depressive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

MDD with melancholic features

Group Type: EXPERIMENTAL

SSRIs/SNRIs (Selective Serotonin Reuptake Inhibitors/ Serotonin and Norepinephrine Reuptake Inhibitors)

Intervention Type: DRUG

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.

Treatment as Usual

Intervention Type: DRUG

The research doctor discusses the treatment plan with the patient, and therapies and drugs are not limited.

SSRIs/SNRIs (Selective Serotonin Reuptake Inhibitors/ Serotonin and Norepinephrine Reuptake Inhibitors) Combined with Magnetic Stimulations

Intervention Type: COMBINATION_PRODUCT

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.

MDD with atypical features

Group Type: EXPERIMENTAL

SSRIs/SNRIs (Selective Serotonin Reuptake Inhibitors/ Serotonin and Norepinephrine Reuptake Inhibitors)

Intervention Type: DRUG

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.

Treatment as Usual

Intervention Type: DRUG

The research doctor discusses the treatment plan with the patient, and therapies and drugs are not limited.

SSRIs/SNRIs (Selective Serotonin Reuptake Inhibitors/ Serotonin and Norepinephrine Reuptake Inhibitors) Combined with Magnetic Stimulations

Intervention Type: COMBINATION_PRODUCT

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.

MDD with anxious distress

Group Type: EXPERIMENTAL

SSRIs/SNRIs (Selective Serotonin Reuptake Inhibitors/ Serotonin and Norepinephrine Reuptake Inhibitors)

Intervention Type: DRUG

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.

Treatment as Usual

Intervention Type: DRUG

The research doctor discusses the treatment plan with the patient, and therapies and drugs are not limited.

SSRIs/SNRIs (Selective Serotonin Reuptake Inhibitors/ Serotonin and Norepinephrine Reuptake Inhibitors) Combined with Magnetic Stimulations

Intervention Type: COMBINATION_PRODUCT

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.

MDD (overall)

Group Type: EXPERIMENTAL

SSRIs/SNRIs (Selective Serotonin Reuptake Inhibitors/ Serotonin and Norepinephrine Reuptake Inhibitors)

Intervention Type: DRUG

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.

Treatment as Usual

Intervention Type: DRUG

The research doctor discusses the treatment plan with the patient, and therapies and drugs are not limited.

SSRIs/SNRIs (Selective Serotonin Reuptake Inhibitors/ Serotonin and Norepinephrine Reuptake Inhibitors) Combined with Magnetic Stimulations

Intervention Type: COMBINATION_PRODUCT

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.

Interventions

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.

Intervention Type: DRUG

Treatment as Usual

The research doctor discusses the treatment plan with the patient, and therapies and drugs are not limited.

Intervention Type: DRUG

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.

Intervention Type: COMBINATION_PRODUCT

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RenJi Hospital

OTHER

Sponsor Role: collaborator

Shanghai 10th People's Hospital

OTHER

Sponsor Role: collaborator

Huashan Hospital

OTHER

Sponsor Role: collaborator

Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: collaborator

Nanjing Medical University

OTHER

Sponsor Role: collaborator

Zhejiang University

OTHER

Sponsor Role: collaborator

Shanghai Mental Health Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Countries

China

Central Contacts

Daihui Peng, MD. PhD.

Role: CONTACT

pdhsh@126.com

18017311136

Facility Contacts

Yiyun Cai

Role: primary

Yanli Luo

Role: primary

Yuan Shen

Role: primary

Other Identifiers

SHZD2020PDH

Identifier Type: -

Identifier Source: org_study_id