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

Depressive Disorder Clinical Trial

— STEP-MDD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03219008
• Other study ID #: 2016YFC1307100
• Status: Recruiting
• Phase: Phase 4
• First received: May 7, 2017
• Last updated: October 8, 2017
• Start date: August 1, 2017
• Est. completion date: December 2020

Study information

• Verified date: May 2017
• Source: Shanghai Mental Health Center
• Contact: Xiaohua Liu
• Phone: +8613918061085
• Email: liuxh_2005[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: December 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease

Intervention

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.

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.

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.

Combination Product:
• physical treatment+fluoxetine+amfebutamone
the investigators recommend drug(fluoxetine and amfebutamone) and physical treatment as intervention.

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

Combination Product:
• fluvoxamine + lithium + physical therapy
the investigators recommend depressants and mood stabilizers as well as physical therapy to help to cure depressive disorder.
• Cognitive behavior treatment +fluvoxamine
the investigators recommend behavioral therapy as well as drugs.

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.

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 .

Drug:
• mirtazapine + SNRIs
the investigator recommend mirtazapine and SNRIs to treat patients with major depressive disorder.

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.

Other:
• TAU(treat as usual)
patients in this group would receive therapy strategies according to their symptoms and preference.

Locations

Country	Name	City	State
China	ShanghaiMHC	Shanghai

Sponsors (17)

Lead Sponsor

Collaborator

Shanghai Mental Health Center

Central South University, Chinese Academy of Sciences, Corning Hospital, Shenzhen City, First Affiliated Hospital Xi'an Jiaotong University, Fourth Military Medical University, Hangzhou Seventh People's Hospital, Peking University Sixth Hospital, Renmin Hospital of Wuhan University, Second Military Medical University, Shandong Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanxi Medical University, The First Affiliated Hospital of Kunming Medical College, the First Specialized Subject Hospital of Harbin, Wuhan Mental Health Center, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in levels of microRNA,apolipoproteins, meta ion (Composite measure)	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.	at 2,4,6,8,12 week.
Secondary	Hamilton Depression Scale(HADA) scores,reductive ratio	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.	at 0,2,4,6,8,12 week.
Secondary	Patient health questionnaire(PHQ-9):the clinical remission ratio	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.	change from baseline PHQ-9 total scores at 2,4,6,8,12 week
Secondary	life event scale(LES)	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.	at baseline
Secondary	social support scale(SSS)	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.	at baseline
Secondary	dysfunctional attitudes scales(DAS)	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.	at baseline
Secondary	the gray matter volume,	The investigators in our study use voxel-based morphometry (VBM8)to record the gray matter volume.	change from baseline neuroimaging data at 2,4,6,8,12 week
Secondary	fractional amplitudes of low-frequency fluctuation(fLAFF)	The investigators in our study use region-of-interest(ROI)to record fLAFF.	change from baseline neuroimaging data at 2,4,6,8,12 week
Secondary	Neuroelectrophysiological examination: electroencephalogram(EEG)	EEG is used to record individual's brain activity. The investigators in our study record individual's brain wave.	at baseline
Secondary	Neuroelectrophysiological examination:electrocardiograph(ECG)	ECG is used to record the individual's cardiac cycle.	at baseline.