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

NCT03219008 | Unknown Phase 4

• 1 other identifier: 2016YFC1307100
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

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.

Conditions

Depressive Disorder

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Hamilton Depression Scale(HADA) scores,reductive ratio

  at 0,2,4,6,8,12 week.

• Patient health questionnaire(PHQ-9):the clinical remission ratio

  change from baseline PHQ-9 total scores at 2,4,6,8,12 week

• life event scale(LES)

  at baseline

• social support scale(SSS)

  at baseline

• dysfunctional attitudes scales(DAS)

  at baseline

Study Arms (13)

Depression/underload 1

EXPERIMENTAL

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

Drug: Fluoxetine

Depression/underload 2

EXPERIMENTAL

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

Combination Product: fluoxetine + cognitive-behavioral treatment（CBT）

Depression/underload 3

EXPERIMENTAL

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

Drug: fluoxetine + Amfebutamone

Depression/underload 4

EXPERIMENTAL

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

Combination Product: physical treatment+fluoxetine+amfebutamone

Atypical 1

EXPERIMENTAL

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

Drug: Fluvoxamine

Atypical 2

EXPERIMENTAL

This group would be treated with fluoxetine + cognitive behavior treatment

Combination Product: Cognitive behavior treatment +fluvoxamine

Atypical 3

EXPERIMENTAL

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

Drug: Lithium+fluvoxamine

Atypical 4

EXPERIMENTAL

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

Combination Product: fluvoxamine + lithium + physical therapy

Anxiety/somatization 1

EXPERIMENTAL

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

Drug: Mirtazapine/SNRIs

Anxiety/somatization 2

EXPERIMENTAL

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

Combination Product: mirtazapine+ Cognitive behavior treatment

Anxiety/somatization 3

EXPERIMENTAL

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

Drug: mirtazapine + SNRIs

Anxiety/somatization 4

EXPERIMENTAL

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

Combination Product: mirtazapine + SNRIs + physical therapy

treatment as usual(TAU)

EXPERIMENTAL

The investigators recommend therapy strategies according to accessible methods.

Other: TAU(treat as usual)

Interventions

Fluoxetine 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 1

fluoxetine + cognitive-behavioral treatment（CBT） 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 2

fluoxetine + Amfebutamone 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 3

physical treatment+fluoxetine+amfebutamone COMBINATION_PRODUCT

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

Depression/underload 4

Fluvoxamine 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 1

Lithium+fluvoxamine DRUG

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

Atypical 3

fluvoxamine + lithium + physical therapy COMBINATION_PRODUCT

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

Atypical 4

Cognitive behavior treatment +fluvoxamine COMBINATION_PRODUCT

the investigators recommend behavioral therapy as well as drugs.

Atypical 2

Mirtazapine/SNRIs 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 1

mirtazapine+ Cognitive behavior treatment COMBINATION_PRODUCT

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

Anxiety/somatization 2

mirtazapine + SNRIs DRUG

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

Anxiety/somatization 3

mirtazapine + SNRIs + physical therapy COMBINATION_PRODUCT

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

Anxiety/somatization 4

TAU(treat as usual) OTHER

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

treatment as usual(TAU)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

ShanghaiMHC

Shanghai, China

RECRUITING

Related Publications (3)

• 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.

  PMID: 36189181 DERIVED

• 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.

  PMID: 35018097 DERIVED

• 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.

  PMID: 33116533 DERIVED

MeSH Terms

Conditions

Depressive Disorder

Interventions

Fluoxetine; Bupropion; Fluvoxamine; Lithium; Physical Therapy Modalities; Mirtazapine; Serotonin and Noradrenaline Reuptake Inhibitors

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Propiophenones; Ketones; Oximes; Hydroxylamines; Metals, Alkali; Elements; Inorganic Chemicals; Metals, Light; Metals; Therapeutics; Rehabilitation; Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Neurotransmitter Agents; Physiological Effects of Drugs

Central Study Contacts

Xiaohua Liu

CONTACT

+8613918061085; liuxh_2005@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: patients with depressive disorder were randomly assigned to different therapy groups or TAU therapy group based on different depressive disorders subtypes.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 7, 2017
• First Posted: July 17, 2017
• Study Start: August 1, 2017
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2020
• Last Updated: October 10, 2017

Record last verified: 2017-05

Locations

CN (1)