MedDataX Logo

Multi-Dimensional Diagnosis,Individualized Therapy,and Management Technique for Major Depressive Disorder:Based on Clinical and Pathological Characteristics

NCT ID: NCT03219008

Last Updated: 2017-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-01

Study Completion Date

2020-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Major Depressive Disorder is one of the most common mental diseases,which increases health-care costs and the financial burden to families and societies. Considering its complex clinical symptoms and diversity of comorbidity, depressive disorder's recognition，diagnosis，and antihistone are based on symptomatology,which is lack of multidimensional diagnosis technique based on clinical pathological characteristics,as well as lack of individualized therapy strategy based on quantified evaluation. Besides, other physical diseases，such as nervous system diseases, cardiovascular diseases，endocrine diseases, have the high comorbidity of depressive disorder. However，there is no precise diagnosis technique or standardized therapy strategy. With all those taken into consideration,our study is aimed to adopt E-mental health and m-Health to explore multi-dimensional diagnosis, individualized therapy and management technique based on molecular biology,nerve electrophysiology，and neuroimaging technology etc.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Four parts included in our study:

Part 1:The research, development and verification of indicators based on biomarkers and clinical characteristics to guide the diagnosis and treatment of depressive disorders

1. to screen biomarkers, to explore its pathophysiology, and to analyze the correlation between clinical subtypes/characteristics and biomarkers.
2. To differentiate the subtypes of depressive disorder（depression/underload, atypical, anxiety/somatization) based on clinical symptoms and clinical assessement.
3. To establish personalized therapy strategies,and to explore tool kits for diagnosis and treatment based on biomarkers and clinical characteristics.
4. to choose appropriate indicators to monitor therapy and side effect by collecting and analyzing blood/imaging/neuropsychological data.

Part 2: The development,transition and application of hierarchical model diagnostic technique for physical diseases combined with depressive disorder.

1. to recruit patients with physical diseases combined with depressive disorder, and explore potential biomarkers.
2. To chose appropriate therapy strategies based on measurement based care（MBC）, providing hierarchical model diagnostic technique for patients.
3. To weigh therapy efficiency and adverse effect among different medicine therapy groups.

Part3: The development and application of comprehensive prevention， diagnosis,and intervention model of depressive disorder.

1. To explore and establish online screening and assistant diagnosis system for patients with depressive disorder.
2. research ,development and application of intelligent e-MBC. Part 4: The development,transition and application of e-MBC sharing platform.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Depressive Disorder

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

depressive disorder multi-dimensional diagnosis technique individualized therapy management technique e-MBC MBC

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Part 2: all patients before receiving any medicine treatment are divided into four groups which adopt different therapy strategies :treatment with fluvoxamine, fluoxetine, mirtazapine and treatment as usual(TAU).Meanwhile，patients with different subtypes of depressive disorder were randomly assigned to different therapy groups.Each therapy groups contains 50 participants.Therefore, the total sample size is 50\*12+200=800.

Part3:To find out efficiency of different kinds of therapy strategies.p=60%, error=5%,a-0.05,the amount of samples nearly is:867,considering the nearly 30% expulsion rate, the final total sample size is 867+260=1127.Therefore,sample size in each group is nearly 376.

Part4:p=60%,error=0.05, a=0.05, exculsion rate=30%,N=867+260=1127.the amount of samples of each group is 1127/3=nearly 400.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
patients with depressive disorder were randomly assigned to different therapy groups or TAU therapy group based on different depressive disorders subtypes.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Depression/underload 1

This group would be treated with fluoxetine from the minimum dosage.

Group Type EXPERIMENTAL

Fluoxetine

Intervention Type DRUG

Fluoxetine is one kind of selective serotonin reuptake inhibitor(SSRIs), whose effect is much better than other non-underload subtypes compared with underload subtypes.So patients would be treated with fluoxetine only.

Depression/underload 2

This group would be treated with fluoxetine combined with cognitive behavior treatment

Group Type EXPERIMENTAL

fluoxetine + cognitive-behavioral treatment（CBT）

Intervention Type COMBINATION_PRODUCT

the investigators would recommend fluoxetine to help to cure depressive disorder.And CBT is a very effective way for patients to alleviate or relieve clinical symptoms during episode stage.

Depression/underload 3

This group would be treated with fluoxetine and amfebutamone from the minimum dosage.

Group Type EXPERIMENTAL

fluoxetine + Amfebutamone

Intervention Type DRUG

Amfebutamone is one kind of SNRIs, and it shows much better therapy effect on patients with exhaustion /dizziness.So the investigators recommend these two drugs to help to cure patients with depressive disorder.

Depression/underload 4

This group would be treated with fluoxetine + physical treatment to help to cure depressive disorder.

Group Type EXPERIMENTAL

physical treatment+fluoxetine+amfebutamone

Intervention Type COMBINATION_PRODUCT

the investigators recommend drug(fluoxetine and amfebutamone) and physical treatment as intervention.

Atypical 1

This group would be treated with fluvoxamine from the minimum dosage.

Group Type EXPERIMENTAL

Fluvoxamine

Intervention Type DRUG

Fluvoxamine could inhibit CYP1A2 and CYP2C19 and affect the metabolism of melatonin, and help to release symptoms of depressive disorder with sleep problems.

Atypical 2

This group would be treated with fluoxetine + cognitive behavior treatment

Group Type EXPERIMENTAL

Cognitive behavior treatment +fluvoxamine

Intervention Type COMBINATION_PRODUCT

the investigators recommend behavioral therapy as well as drugs.

Atypical 3

This group would be treated with fluvoxamine + lithium from the minimum dosage.

Group Type EXPERIMENTAL

Lithium+fluvoxamine

Intervention Type DRUG

the investigators recommend lithium as a mood stabilizer and use fluvoxamine to affect the level of melatonin.

Atypical 4

This group would be treated with fluvoxamine + lithium + physical treatment

Group Type EXPERIMENTAL

fluvoxamine + lithium + physical therapy

Intervention Type COMBINATION_PRODUCT

the investigators recommend depressants and mood stabilizers as well as physical therapy to help to cure depressive disorder.

Anxiety/somatization 1

This group would be treated with mirtazapine/selective serotonin-norepinephrine reuptake inhibitors（SNRIs） from the minimum dosage.

Group Type EXPERIMENTAL

Mirtazapine/SNRIs

Intervention Type DRUG

Mirtazapine is one kind of antagonist of a2 adrenergic receptors and could block 5-hydroxytryptamine2 and 5-hydroxytryptamine3,help to release symptoms like anxiety or somatization.Besides, SNRIs could also make similar effect on patients.Therefore, the investigators recommend mirtazapine/SNRIs to treat patients with depressive disorder.

Anxiety/somatization 2

This group would be treated with mirtazapine/SNRIs + cognitive behavior treatment.

Group Type EXPERIMENTAL

mirtazapine+ Cognitive behavior treatment

Intervention Type COMBINATION_PRODUCT

the investigators recommend CBT and mirtazapine as interventions.The dosage and frequency would depend on patients' severity of symptoms .

Anxiety/somatization 3

This group would be treated with mirtazapine + SNRIs from the minimum dosage.

Group Type EXPERIMENTAL

mirtazapine + SNRIs

Intervention Type DRUG

the investigator recommend mirtazapine and SNRIs to treat patients with major depressive disorder.

Anxiety/somatization 4

This group would be treated with mirtazapine + SNRIs + physical treatment.

Group Type EXPERIMENTAL

mirtazapine + SNRIs + physical therapy

Intervention Type COMBINATION_PRODUCT

the investigators would manage to use drugs and physical treatment to help to release the symptoms of depressive disorder.

treatment as usual(TAU)

The investigators recommend therapy strategies according to accessible methods.

Group Type EXPERIMENTAL

TAU(treat as usual)

Intervention Type OTHER

patients in this group would receive therapy strategies according to their symptoms and preference.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Fluoxetine

Fluoxetine is one kind of selective serotonin reuptake inhibitor(SSRIs), whose effect is much better than other non-underload subtypes compared with underload subtypes.So patients would be treated with fluoxetine only.

Intervention Type DRUG

fluoxetine + cognitive-behavioral treatment（CBT）

the investigators would recommend fluoxetine to help to cure depressive disorder.And CBT is a very effective way for patients to alleviate or relieve clinical symptoms during episode stage.

Intervention Type COMBINATION_PRODUCT

fluoxetine + Amfebutamone

Amfebutamone is one kind of SNRIs, and it shows much better therapy effect on patients with exhaustion /dizziness.So the investigators recommend these two drugs to help to cure patients with depressive disorder.

Intervention Type DRUG

physical treatment+fluoxetine+amfebutamone

the investigators recommend drug(fluoxetine and amfebutamone) and physical treatment as intervention.

Intervention Type COMBINATION_PRODUCT

Fluvoxamine

Fluvoxamine could inhibit CYP1A2 and CYP2C19 and affect the metabolism of melatonin, and help to release symptoms of depressive disorder with sleep problems.

Intervention Type DRUG

Lithium+fluvoxamine

the investigators recommend lithium as a mood stabilizer and use fluvoxamine to affect the level of melatonin.

Intervention Type DRUG

fluvoxamine + lithium + physical therapy

the investigators recommend depressants and mood stabilizers as well as physical therapy to help to cure depressive disorder.

Intervention Type COMBINATION_PRODUCT

Cognitive behavior treatment +fluvoxamine

the investigators recommend behavioral therapy as well as drugs.

Intervention Type COMBINATION_PRODUCT

Mirtazapine/SNRIs

Mirtazapine is one kind of antagonist of a2 adrenergic receptors and could block 5-hydroxytryptamine2 and 5-hydroxytryptamine3,help to release symptoms like anxiety or somatization.Besides, SNRIs could also make similar effect on patients.Therefore, the investigators recommend mirtazapine/SNRIs to treat patients with depressive disorder.

Intervention Type DRUG

mirtazapine+ Cognitive behavior treatment

the investigators recommend CBT and mirtazapine as interventions.The dosage and frequency would depend on patients' severity of symptoms .

Intervention Type COMBINATION_PRODUCT

mirtazapine + SNRIs

the investigator recommend mirtazapine and SNRIs to treat patients with major depressive disorder.

Intervention Type DRUG

mirtazapine + SNRIs + physical therapy

the investigators would manage to use drugs and physical treatment to help to release the symptoms of depressive disorder.

Intervention Type COMBINATION_PRODUCT

TAU(treat as usual)

patients in this group would receive therapy strategies according to their symptoms and preference.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* aged 18-65 years;
* clinical diagnosis of major depressive disorder;
* 17-Hamilton Depression Scale\>20;
* 14-Hamilton Anxiety Scale score\<7;
* outpatient treatment;
* first episode;
* medication-naive;

Exclusion Criteria

* clinical diagnosis of schizophrenia, schizoaffective disorder;
* any prescription or psychotropic medications in the past 4 week;
* serious medical or neurological illness;
* current pregnancy or breastfeeding.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role collaborator

Chinese Academy of Sciences

OTHER_GOV

Sponsor Role collaborator

Shanxi Medical University

OTHER

Sponsor Role collaborator

Central South University

OTHER

Sponsor Role collaborator

Second Military Medical University

OTHER

Sponsor Role collaborator

Peking University Sixth Hospital

OTHER

Sponsor Role collaborator

First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role collaborator

First Affiliated Hospital of Kunming Medical University

OTHER

Sponsor Role collaborator

Air Force Military Medical University, China

OTHER

Sponsor Role collaborator

Zhejiang University

OTHER

Sponsor Role collaborator

Wuhan Mental Health Centre

OTHER

Sponsor Role collaborator

Corning Hospital, Shenzhen City

UNKNOWN

Sponsor Role collaborator

the First Specialized Subject Hospital of Harbin

UNKNOWN

Sponsor Role collaborator

Renmin Hospital of Wuhan University

OTHER

Sponsor Role collaborator

Seventh People's Hospital of Hangzhou

OTHER

Sponsor Role collaborator

Shandong Mental Health Center

OTHER

Sponsor Role collaborator

Shanghai Mental Health Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

ShanghaiMHC

Shanghai, , China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Xiaohua Liu

Role: CONTACT

Phone: +8613918061085

Email: [email protected]

References

Explore related publications, articles, or registry entries linked to this study.

Liu H, Wu X, Wang Y, Liu X, Peng D, Wu Y, Chen J, Su Y, Xu J, Ma X, Li Y, Shi J, Yang X, Rong H, Forti MD, Fang Y. TNF-alpha, IL-6 and hsCRP in patients with melancholic, atypical and anxious depression: an antibody array analysis related to somatic symptoms. Gen Psychiatr. 2022 Sep 8;35(4):e100844. doi: 10.1136/gpsych-2022-100844. eCollection 2022.

Reference Type DERIVED
PMID: 36189181 (View on PubMed)

Wang Y, Liu X, Peng D, Wu Y, Su Y, Xu J, Ma X, Li Y, Shi J, Cheng X, Rong H, Fang Y. A Preliminary Study of Different Treatment Strategies for Anxious Depression. Neuropsychiatr Dis Treat. 2022 Jan 4;18:11-18. doi: 10.2147/NDT.S320091. eCollection 2022.

Reference Type DERIVED
PMID: 35018097 (View on PubMed)

Liu X, Wang Y, Peng D, Zhang H, Zheng Y, Wu Y, Su YA, Liu M, Ma X, Li Y, Shi J, Cheng X, Rong H, Fang Y. The Developmental and Translational Study on Biomarkers and Clinical Characteristics-based Diagnostic and Therapeutic Identification of Major Depressive Disorder: Study Protocol for a Multicenter Randomized Controlled Trial in China. Neuropsychiatr Dis Treat. 2020 Oct 9;16:2343-2351. doi: 10.2147/NDT.S271842. eCollection 2020.

Reference Type DERIVED
PMID: 33116533 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2016YFC1307100

Identifier Type: -

Identifier Source: org_study_id