Depressive DisorderPhase 4STEP-MDDNCT03219008
Multi-Dimensional Diagnosis,Individualized Therapy,and Management Technique for Major Depressive Disorder:Based on Clinical and Pathological Characteristics
A Phase 4 study testing Fluoxetine, fluoxetine + cognitive-behavioral treatment（CBT） and fluoxetine + Amfebutamone in people with Depressive Disorder, run by Shanghai Mental Health Center at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depressive Disorder
- What is being tested?
- Fluoxetine, fluoxetine + cognitive-behavioral treatment（CBT） and fluoxetine + Amfebutamone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2017to Dec 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multi-dimensional Diagnosis,Individualized Therapy,and Management Technique for Major Depressive Disorder:Based on Clinical and Pathological Characteristics
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.
Read the 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
- to screen biomarkers, to explore its pathophysiology, and to analyze the correlation between clinical subtypes/characteristics and biomarkers.
- To differentiate the subtypes of depressive disorder（depression/underload, atypical, anxiety/somatization) based on clinical symptoms and clinical assessement.
- To establish personalized therapy strategies,and to explore tool kits for diagnosis and treatment based on biomarkers and clinical characteristics.
- 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.
- to recruit patients with physical diseases combined with depressive disorder, and explore potential biomarkers.
- To chose appropriate therapy strategies based on measurement based care（MBC）, providing hierarchical model diagnostic technique for patients.
- 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.
- To explore and establish online screening and assistant diagnosis system for patients with depressive disorder.
- research ,development and application of intelligent e-MBC. Part 4: The development,transition and application of e-MBC sharing platform.
- Conditions
- Depressive Disorder
- Being tested
- Fluoxetine, fluoxetine + cognitive-behavioral treatment（CBT）, fluoxetine + Amfebutamone, physical treatment+fluoxetine+amfebutamone, Fluvoxamine
- Keywords
- depressive disorder, multi-dimensional diagnosis technique, individualized therapy, management technique, e-MBC, MBC
- Medical subject headings
- Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluoxetineDrug
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.
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.
fluoxetine + AmfebutamoneDrug
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.
physical treatment+fluoxetine+amfebutamoneCombination product
the investigators recommend drug(fluoxetine and amfebutamone) and physical treatment as intervention.
FluvoxamineDrug
Fluvoxamine could inhibit CYP1A2 and CYP2C19 and affect the metabolism of melatonin, and help to release symptoms of depressive disorder with sleep problems.
Lithium+fluvoxamineDrug
the investigators recommend lithium as a mood stabilizer and use fluvoxamine to affect the level of melatonin.
fluvoxamine + lithium + physical therapyCombination product
the investigators recommend depressants and mood stabilizers as well as physical therapy to help to cure depressive disorder.
Cognitive behavior treatment +fluvoxamineCombination product
the investigators recommend behavioral therapy as well as drugs.
Mirtazapine/SNRIsDrug
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.
mirtazapine+ Cognitive behavior treatmentCombination product
the investigators recommend CBT and mirtazapine as interventions.The dosage and frequency would depend on patients' severity of symptoms .
mirtazapine + SNRIsDrug
the investigator recommend mirtazapine and SNRIs to treat patients with major depressive disorder.
mirtazapine + SNRIs + physical therapyCombination product
the investigators would manage to use drugs and physical treatment to help to release the symptoms of depressive disorder.
TAU(treat as usual)Other
patients in this group would receive therapy strategies according to their symptoms and preference.
| Study group | Role | What they receive |
|---|---|---|
| Depression/underload 1 | Experimental | This group would be treated with fluoxetine from the minimum dosage. Receives: Drug: Fluoxetine |
| Depression/underload 2 | Experimental | This group would be treated with fluoxetine combined with cognitive behavior treatment Receives: Combination Product: fluoxetine + cognitive-behavioral treatment（CBT） |
| Depression/underload 3 | Experimental | This group would be treated with fluoxetine and amfebutamone from the minimum dosage. Receives: Drug: fluoxetine + Amfebutamone |
| Depression/underload 4 | Experimental | This group would be treated with fluoxetine + physical treatment to help to cure depressive disorder. Receives: Combination Product: physical treatment+fluoxetine+amfebutamone |
| Atypical 1 | Experimental | This group would be treated with fluvoxamine from the minimum dosage. Receives: Drug: Fluvoxamine |
| Atypical 2 | Experimental | This group would be treated with fluoxetine + cognitive behavior treatment Receives: Combination Product: Cognitive behavior treatment +fluvoxamine |
| Atypical 3 | Experimental | This group would be treated with fluvoxamine + lithium from the minimum dosage. Receives: Drug: Lithium+fluvoxamine |
| Atypical 4 | Experimental | This group would be treated with fluvoxamine + lithium + physical treatment Receives: 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. Receives: Drug: Mirtazapine/SNRIs |
| Anxiety/somatization 2 | Experimental | This group would be treated with mirtazapine/SNRIs + cognitive behavior treatment. Receives: Combination Product: mirtazapine+ Cognitive behavior treatment |
| Anxiety/somatization 3 | Experimental | This group would be treated with mirtazapine + SNRIs from the minimum dosage. Receives: Drug: mirtazapine + SNRIs |
| Anxiety/somatization 4 | Experimental | This group would be treated with mirtazapine + SNRIs + physical treatment. Receives: Combination Product: mirtazapine + SNRIs + physical therapy |
| treatment as usual(TAU) | Experimental | The investigators recommend therapy strategies according to accessible methods. Receives: Other: TAU(treat as usual) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at 2,4,6,8,12 week.
Secondary outcomes (9)
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.
Measured: at 0,2,4,6,8,12 week.
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.
Measured: change from baseline PHQ-9 total scores at 2,4,6,8,12 week
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.
Measured: at baseline
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.
Measured: at baseline
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.
Measured: at baseline
the gray matter volume,
The investigators in our study use voxel-based morphometry (VBM8)to record the gray matter volume.
Measured: change from baseline neuroimaging data at 2,4,6,8,12 week
fractional amplitudes of low-frequency fluctuation(fLAFF)
The investigators in our study use region-of-interest(ROI)to record fLAFF.
Measured: change from baseline neuroimaging data at 2,4,6,8,12 week
Neuroelectrophysiological examination: electroencephalogram(EEG)
EEG is used to record individual's brain activity. The investigators in our study record individual's brain wave.
Measured: at baseline
Neuroelectrophysiological examination:electrocardiograph(ECG)
ECG is used to record the individual's cardiac cycle.
Measured: at baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2017
- Study start1 Aug 2017
- Primary completionDec 2019 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Shanghai Mental Health CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- 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, First Affiliated Hospital of Kunming Medical University, 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
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03219008
- Sponsor's protocol ID
- 2016YFC1307100
- Acronym
- STEP-MDD
- Status last verified
- May 2017
- First submitted
- 7 May 2017
- Last updated
- 10 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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
Publications
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.
PubMed 36189181Wang 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.
PubMed 35018097Liu 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.
PubMed 33116533
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-dimensional Diagnosis,Individualized Therapy,and Management Technique for Major Depressive Disorder:Based on Clinical and Pathological Characteristics
- ClinicalTrials.gov ID
- NCT03219008
- Acronym / sponsor ID
- STEP-MDD / 2016YFC1307100
- Conditions
- Depressive Disorder
- Keywords
- depressive disorder, multi-dimensional diagnosis technique, individualized therapy, management technique, e-MBC, MBC
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- 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, First Affiliated Hospital of Kunming Medical University, 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
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 17 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- to screen biomarkers, to explore its pathophysiology, and to analyze the correlation between clinical subtypes/characteristics and biomarkers.
- To differentiate the subtypes of depressive disorder（depression/underload, atypical, anxiety/somatization) based on clinical symptoms and clinical assessement.
- To establish personalized therapy strategies,and to explore tool kits for diagnosis and treatment based on biomarkers and clinical characteristics.
- 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.
- to recruit patients with physical diseases combined with depressive disorder, and explore potential biomarkers.
- To chose appropriate therapy strategies based on measurement based care（MBC）, providing hierarchical model diagnostic technique for patients.
- 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.
- To explore and establish online screening and assistant diagnosis system for patients with depressive disorder.
- research ,development and application of intelligent e-MBC. Part 4: The development,transition and application of e-MBC sharing platform.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 13
- 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.
| Arm | Type | Receives |
|---|---|---|
| Depression/underload 1 | Experimental | Drug: FluoxetineThis group would be treated with fluoxetine from the minimum dosage. |
| Depression/underload 2 | Experimental | Combination Product: fluoxetine + cognitive-behavioral treatment（CBT）This group would be treated with fluoxetine combined with cognitive behavior treatment |
| Depression/underload 3 | Experimental | Drug: fluoxetine + AmfebutamoneThis group would be treated with fluoxetine and amfebutamone from the minimum dosage. |
| Depression/underload 4 | Experimental | Combination Product: physical treatment+fluoxetine+amfebutamoneThis group would be treated with fluoxetine + physical treatment to help to cure depressive disorder. |
| Atypical 1 | Experimental | Drug: FluvoxamineThis group would be treated with fluvoxamine from the minimum dosage. |
| Atypical 2 | Experimental | Combination Product: Cognitive behavior treatment +fluvoxamineThis group would be treated with fluoxetine + cognitive behavior treatment |
| Atypical 3 | Experimental | Drug: Lithium+fluvoxamineThis group would be treated with fluvoxamine + lithium from the minimum dosage. |
| Atypical 4 | Experimental | Combination Product: fluvoxamine + lithium + physical therapyThis group would be treated with fluvoxamine + lithium + physical treatment |
| Anxiety/somatization 1 | Experimental | Drug: Mirtazapine/SNRIsThis group would be treated with mirtazapine/selective serotonin-norepinephrine reuptake inhibitors（SNRIs） from the minimum dosage. |
| Anxiety/somatization 2 | Experimental | Combination Product: mirtazapine+ Cognitive behavior treatmentThis group would be treated with mirtazapine/SNRIs + cognitive behavior treatment. |
| Anxiety/somatization 3 | Experimental | Drug: mirtazapine + SNRIsThis group would be treated with mirtazapine + SNRIs from the minimum dosage. |
| Anxiety/somatization 4 | Experimental | Combination Product: mirtazapine + SNRIs + physical therapyThis group would be treated with mirtazapine + SNRIs + physical treatment. |
| treatment as usual(TAU) | Experimental | Other: TAU(treat as usual)The investigators recommend therapy strategies according to accessible methods. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- aged 18-65 years;
- clinical diagnosis of major depressive disorder;
- 17-Hamilton Depression Scale>20;
- 14-Hamilton Anxiety Scale score<7;
- outpatient treatment;
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FluoxetineFluoxetine 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. | Drug | Depression/underload 1 |
| 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. | Combination product | Depression/underload 2 |
| fluoxetine + AmfebutamoneAmfebutamone 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. | Drug | Depression/underload 3 |
| physical treatment+fluoxetine+amfebutamonethe investigators recommend drug(fluoxetine and amfebutamone) and physical treatment as intervention. | Combination product | Depression/underload 4 |
| FluvoxamineFluvoxamine could inhibit CYP1A2 and CYP2C19 and affect the metabolism of melatonin, and help to release symptoms of depressive disorder with sleep problems. | Drug | Atypical 1 |
| Lithium+fluvoxaminethe investigators recommend lithium as a mood stabilizer and use fluvoxamine to affect the level of melatonin. | Drug | Atypical 3 |
| fluvoxamine + lithium + physical therapythe investigators recommend depressants and mood stabilizers as well as physical therapy to help to cure depressive disorder. | Combination product | Atypical 4 |
| Cognitive behavior treatment +fluvoxaminethe investigators recommend behavioral therapy as well as drugs. | Combination product | Atypical 2 |
| Mirtazapine/SNRIsMirtazapine 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. | Drug | Anxiety/somatization 1 |
| mirtazapine+ Cognitive behavior treatmentthe investigators recommend CBT and mirtazapine as interventions.The dosage and frequency would depend on patients' severity of symptoms . | Combination product | Anxiety/somatization 2 |
| mirtazapine + SNRIsthe investigator recommend mirtazapine and SNRIs to treat patients with major depressive disorder. | Drug | Anxiety/somatization 3 |
| mirtazapine + SNRIs + physical therapythe investigators would manage to use drugs and physical treatment to help to release the symptoms of depressive disorder. | Combination product | Anxiety/somatization 4 |
| TAU(treat as usual)patients in this group would receive therapy strategies according to their symptoms and preference. | Other | treatment as usual(TAU) |
Primary outcome
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.
9 secondary outcomes
Hamilton Depression Scale(HADA) scores,reductive ratio
Time frame: at 0,2,4,6,8,12 week.
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
life event scale(LES)
Time frame: at baseline
social support scale(SSS)
Time frame: at baseline
dysfunctional attitudes scales(DAS)
Time frame: at baseline
the gray matter volume,
Time frame: change from baseline neuroimaging data at 2,4,6,8,12 week
fractional amplitudes of low-frequency fluctuation(fLAFF)
Time frame: change from baseline neuroimaging data at 2,4,6,8,12 week
Neuroelectrophysiological examination: electroencephalogram(EEG)
Time frame: at baseline
Neuroelectrophysiological examination:electrocardiograph(ECG)
Time frame: at baseline.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2017.
- Derived from this study: PubMed 36189181Liu 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.
- Derived from this study: PubMed 35018097Wang 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.
- Derived from this study: PubMed 33116533Liu 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.
- Individual participant dataSharing planned: Undecided. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fluoxetine, fluoxetine + cognitive-behavioral treatment（CBT） and fluoxetine + Amfebutamone in people with Depressive Disorder, run by Shanghai Mental Health Center at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaohua Liu (+8613918061085, liuxh_2005@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in levels of microRNA，apolipoproteins, meta ion (Composite measure) (time frame: at 2,4,6,8,12 week.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03219008, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2017.