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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03219008
Recruitment Status : Unknown
Verified May 2017 by Shanghai Mental Health Center.
Recruitment status was:  Recruiting
First Posted : July 17, 2017
Last Update Posted : October 10, 2017
Sponsor:
Collaborators:
Shanghai Jiao Tong University School of Medicine
Chinese Academy of Sciences
Shanxi Medical University
Central South University
Second Military Medical University
Peking University Sixth Hospital
First Affiliated Hospital Xi'an Jiaotong University
The First Affiliated Hospital of Kunming Medical College
Air Force Military Medical University, China
Zhejiang University
Wuhan Mental Health Centre
Corning Hospital, Shenzhen City
the First Specialized Subject Hospital of Harbin
Renmin Hospital of Wuhan University
Seventh People's Hospital of Hangzhou
Shandong Mental Health Center
Information provided by (Responsible Party):
Shanghai Mental Health Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Depressive Disorder Drug: Fluoxetine Combination Product: fluoxetine + cognitive-behavioral treatment(CBT) Drug: fluoxetine + Amfebutamone Combination Product: physical treatment+fluoxetine+amfebutamone Drug: Fluvoxamine Drug: Lithium+fluvoxamine Combination Product: fluvoxamine + lithium + physical therapy Combination Product: Cognitive behavior treatment +fluvoxamine Drug: Mirtazapine/SNRIs Combination Product: mirtazapine+ Cognitive behavior treatment Drug: mirtazapine + SNRIs Combination Product: mirtazapine + SNRIs + physical therapy Other: TAU(treat as usual) Phase 4

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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.

Masking: Double (Participant, Outcomes Assessor)
Masking Description: patients with depressive disorder were randomly assigned to different therapy groups or TAU therapy group based on different depressive disorders subtypes.
Primary Purpose: Treatment
Official Title: Multi-dimensional Diagnosis,Individualized Therapy,and Management Technique for Major Depressive Disorder:Based on Clinical and Pathological Characteristics
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Depression/underload 1
This group would be treated with fluoxetine from the minimum dosage.
Drug: 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.

Experimental: Depression/underload 2
This group would be treated with fluoxetine combined with cognitive behavior treatment
Combination Product: 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.

Experimental: Depression/underload 3
This group would be treated with fluoxetine and amfebutamone from the minimum dosage.
Drug: 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.

Experimental: Depression/underload 4
This group would be treated with fluoxetine + physical treatment to help to cure depressive disorder.
Combination Product: physical treatment+fluoxetine+amfebutamone
the investigators recommend drug(fluoxetine and amfebutamone) and physical treatment as intervention.

Experimental: Atypical 1
This group would be treated with fluvoxamine from the minimum dosage.
Drug: Fluvoxamine
Fluvoxamine could inhibit CYP1A2 and CYP2C19 and affect the metabolism of melatonin, and help to release symptoms of depressive disorder with sleep problems.

Experimental: Atypical 2
This group would be treated with fluoxetine + cognitive behavior treatment
Combination Product: Cognitive behavior treatment +fluvoxamine
the investigators recommend behavioral therapy as well as drugs.

Experimental: Atypical 3
This group would be treated with fluvoxamine + lithium from the minimum dosage.
Drug: Lithium+fluvoxamine
the investigators recommend lithium as a mood stabilizer and use fluvoxamine to affect the level of melatonin.

Experimental: Atypical 4
This group would be treated with fluvoxamine + lithium + physical treatment
Combination Product: fluvoxamine + lithium + physical therapy
the investigators recommend depressants and mood stabilizers as well as physical therapy to help to cure depressive disorder.

Experimental: Anxiety/somatization 1
This group would be treated with mirtazapine/selective serotonin-norepinephrine reuptake inhibitors(SNRIs) from the minimum dosage.
Drug: 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.

Experimental: Anxiety/somatization 2
This group would be treated with mirtazapine/SNRIs + cognitive behavior treatment.
Combination Product: mirtazapine+ Cognitive behavior treatment
the investigators recommend CBT and mirtazapine as interventions.The dosage and frequency would depend on patients' severity of symptoms .

Experimental: Anxiety/somatization 3
This group would be treated with mirtazapine + SNRIs from the minimum dosage.
Drug: mirtazapine + SNRIs
the investigator recommend mirtazapine and SNRIs to treat patients with major depressive disorder.

Experimental: Anxiety/somatization 4
This group would be treated with mirtazapine + SNRIs + physical treatment.
Combination Product: mirtazapine + SNRIs + physical therapy
the investigators would manage to use drugs and physical treatment to help to release the symptoms of depressive disorder.

Experimental: treatment as usual(TAU)
The investigators recommend therapy strategies according to accessible methods.
Other: TAU(treat as usual)
patients in this group would receive therapy strategies according to their symptoms and preference.




Primary Outcome Measures :
  1. Change from baseline in levels of microRNA,apolipoproteins, meta ion (Composite measure) [ Time Frame: at 2,4,6,8,12 week. ]
    The potential biomarkers in our study include microRNA,apolipoproteins,metallic ion etc.We use quantitative analysis technique to test miRNA,proteins and metallic ion by patients' blood and urines before interventions and after interventions.


Secondary Outcome Measures :
  1. Hamilton Depression Scale(HADA) scores,reductive ratio [ Time Frame: at 0,2,4,6,8,12 week. ]
    HADA,created by Hamilton in 1960,is one of the most common questionnaires to evaluate the severity of depression and the efficiency of medicine. we adopt the Hamilton Depression Scale(HADA)to evaluate different medicines efficiency by analyzing reductive ratio.The investigators record the total scores of HADA at baseline and 2,4,6,8,12 week.

  2. Patient health questionnaire(PHQ-9):the clinical remission ratio [ Time Frame: change from baseline PHQ-9 total scores at 2,4,6,8,12 week ]
    PHQ-9 is a self-report scale composed of 9 items to evaluate the state of depression.The investigators in our study record the total scores of PHQ-9 at 0,2,4,6,8,12 week to analyze the clinical remission ratio.

  3. life event scale(LES) [ Time Frame: at baseline ]
    LES is one of the common questionnaires to evaluate individual's mental and stress stimulation in daily life.The investigators record the total scores of LES at baseline.

  4. social support scale(SSS) [ Time Frame: at baseline ]
    SSS is one of the common questionnaires to evaluate individual's social support and social relationship network to explore the correlation between social support and mental health. the investigators in our study record the total scores of SSS at baseline.

  5. dysfunctional attitudes scales(DAS) [ Time Frame: at baseline ]
    The DAS is a self-report scale composed of 40 items to assess typical, stable depressogenic attitudes or schemas that make individuals vulnerable to depression. The investigators in our study record the total scores od DAS at baseline.

  6. the gray matter volume, [ Time Frame: change from baseline neuroimaging data at 2,4,6,8,12 week ]
    The investigators in our study use voxel-based morphometry (VBM8)to record the gray matter volume.

  7. fractional amplitudes of low-frequency fluctuation(fLAFF) [ Time Frame: change from baseline neuroimaging data at 2,4,6,8,12 week ]
    The investigators in our study use region-of-interest(ROI)to record fLAFF.

  8. Neuroelectrophysiological examination: electroencephalogram(EEG) [ Time Frame: at baseline ]
    EEG is used to record individual's brain activity. The investigators in our study record individual's brain wave.

  9. Neuroelectrophysiological examination:electrocardiograph(ECG) [ Time Frame: at baseline. ]
    ECG is used to record the individual's cardiac cycle.



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 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT03219008


Contacts
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Contact: Xiaohua Liu +8613918061085 liuxh_2005@126.com

Locations
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China
ShanghaiMHC Recruiting
Shanghai, China
Sponsors and Collaborators
Shanghai Mental Health Center
Shanghai Jiao Tong University School of Medicine
Chinese Academy of Sciences
Shanxi Medical University
Central South University
Second Military Medical University
Peking University Sixth Hospital
First Affiliated Hospital Xi'an Jiaotong University
The First Affiliated Hospital of Kunming Medical College
Air Force Military Medical University, China
Zhejiang University
Wuhan Mental Health Centre
Corning Hospital, Shenzhen City
the First Specialized Subject Hospital of Harbin
Renmin Hospital of Wuhan University
Seventh People's Hospital of Hangzhou
Shandong Mental Health Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Shanghai Mental Health Center
ClinicalTrials.gov Identifier: NCT03219008    
Other Study ID Numbers: 2016YFC1307100
First Posted: July 17, 2017    Key Record Dates
Last Update Posted: October 10, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: To share raw data via the network platform named Clinical Trial Management Public Platform within 1year after the trial finished. And the platform website address is http://www.medresman.org

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shanghai Mental Health Center:
depressive disorder
multi-dimensional diagnosis technique
individualized therapy
management technique
e-MBC
MBC
Additional relevant MeSH terms:
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Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Lithium Carbonate
Mirtazapine
Fluvoxamine
Fluoxetine
Bupropion
Serotonin and Noradrenaline Reuptake Inhibitors
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants