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Neurochemical, Metabonomics and Neuroimaging Characterization of TCM Diagnostic Subtypes of Major Depression Disorder (NMNTDM)

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ClinicalTrials.gov Identifier: NCT02346682
Recruitment Status : Unknown
Verified April 2015 by Lan-ying Liu, Zhejiang Provincial Tongde Hospital.
Recruitment status was:  Recruiting
First Posted : January 27, 2015
Last Update Posted : April 27, 2015
Sponsor:
Collaborator:
The University of Hong Kong
Information provided by (Responsible Party):
Lan-ying Liu, Zhejiang Provincial Tongde Hospital

Brief Summary:

There is heterogeneity in patients with depression. Many scholars propose that individualization of antidepressant achieves better outcomes. However, the scientific theoretical basis of individualized treatment is still quite weak. Different clinical subtypes of depression and their possible biomarkers are critically needed to provide the individualization with theoretical base. Diagnostic types of major depression disorder (MDD) based on the Theory of Traditional Chinese Medicine (TCM) and possible differentiations in neurobiochemistry, metabonomics and neuroimaging could be one of ways to explore the biomarkers and support the theory of the individualized treatment.

The hypothesized results will be of help to clarify the biological basis of MDD with LDQS and with DBHS, to provide the TCM with further scientific evidence, to explore the pathogenesis of depression, to improve the objective diagnosis of depression, and to promote targeted interventions by Western medicine, TCM or both.


Condition or disease Intervention/treatment Phase
Severe Major Depression Disorder Drug: venlafaxine Phase 4

Detailed Description:
The objectives of this study is to explore if there are any differences in neurobiochemistry, metabonomics and neuroimaging (1) at the baseline, between the subjects who are the normal controls (C Group) and who both meet diagnostic criteria of the Diagnostic and Statistical Manual of 5th edition (DSM-V) on MDD and TCM criteria of 'pattern of Liver Depression and Qi Stagnation (LDQS)' or'pattern of Deficiency of Both Heart and Spleen (DBHS)' (T Group); (2) at the baseline, between the MDD subjects of LDQS and DBHS; (3) after 6-week venlafaxine administration, between the MDD subjects of LDQS and DBHS. 50 subjects in T Group and 25 in C Group are recruited in the study and the main laboratory tests include High Performance Liquid Chromatography(HPLC), Gas Chromatography-Mass Spectrum(GCMS) and neuroimaging DTI technology.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Neurochemical,Metabonomics and Neuroimaging Characterization of TCM Diagnostic Subtypes of Major Depression Disorder
Study Start Date : February 2015
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: LDQS group

Liver Depression and Qi Stagnation (LDQS)group,Liver Depression and Qi Stagnation Syndrome should include at least the following 5 symptoms and signs: emotional depression or sadness, pessimism, short breath, sigh, dysphoria,thin coating,stringy pulse Drugs use generic name :Venlafaxine; Dosage form:capsule Dosage, frequency and duration:Venlafaxine dose was initiated at 75 mg/day and escalated to an optimal dose (150-225 mg/day in most cases) within 2 week, depending upon individual patient response, but the maximum dose could not exceed 300 mg/day during the next 4 weeks.

The biomarkers of neurobiochemistry, metabonomics and neuroimaging would be tested at the baseline and after 6-week venlafaxine administration.

Drug: venlafaxine
Venlafaxine dose was initiated at 75 mg/day and escalated to an optimal dose (150-225 mg/day in most cases) within 2 week, depending upon individual patient response, but the maximum dose could not exceed 300 mg/day during the next 4 weeks. Patients were prescribed a combination of venlafaxine and Benzodiazepines for sleep disturbance.
Other Name: clonazepam

Active Comparator: DBHS group

Deficiency of Both Heart and Spleen (DBHS) group,Deficiency of Both Heart and Spleen Syndrome should include at least following 6 symptoms and signs: emotional depression, thinking torpidity, tiredness, forgetfulness, insomnia, loose stool, sweating, pale tongue body, thin tongue coating, and thin and deep pulse Drugs use generic name :Venlafaxine; Dosage form:capsule Dosage, frequency and duration:Venlafaxine dose was initiated at 75 mg/day and escalated to an optimal dose (150-225 mg/day in most cases) within 2 week, depending upon individual patient response, but the maximum dose could not exceed 300 mg/day during the next 4 weeks.

The biomarkers of neurobiochemistry, metabonomics and neuroimaging would be tested at the baseline and after 6-week .

Drug: venlafaxine
Venlafaxine dose was initiated at 75 mg/day and escalated to an optimal dose (150-225 mg/day in most cases) within 2 week, depending upon individual patient response, but the maximum dose could not exceed 300 mg/day during the next 4 weeks. Patients were prescribed a combination of venlafaxine and Benzodiazepines for sleep disturbance.
Other Name: clonazepam

No Intervention: the normal controls group
The normal controls group including the healthy volunteer None drug The biomarkers of neurobiochemistry, metabonomics and neuroimaging would be tested at the baseline .



Primary Outcome Measures :
  1. Brain neuroimaging [ Time Frame: 2 years ]
    Diffusion Tensor Imaging(DTI) is used to detect changes in FA maps of brain white matter fiber in major depressive patients


Secondary Outcome Measures :
  1. Biochemical tests [ Time Frame: 2 years ]

    Gas Chromatography-Mass Spectrum is used to test blood and urine samples for:

    lactic acid, alanine, 3 - hydroxy butyric acid, valine, carbamide, glycerinum, phosphoric acid, isoleucine, glycine, succinic acid, threonine, malic acid, glutamic acid, citric acid, stearic acid, GABA, methionine, cysteine, lysine, tryptophan, leucine, methionine and tyrosine.



Other Outcome Measures:
  1. Neurochemical tests [ Time Frame: 2 years ]

    High Performance Liquid Chromatography (HPLC) is used to detect blood samples for:

    5-HT, NE, DA, 5-HTAA, and HVA.




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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Had a diagnosis of major depressive disorder according to DSM-V and TCM criteria of 'pattern of Liver Depression and Qi Stagnation (LDQS)' or'pattern of Deficiency of Both Heart and Spleen (DBHS)
  2. The severity of the symptoms is moderate or severe, confirmed by a 35 or greater of Hamilton Rating Scale for Depression(HAMD) score
  3. Absence of brain and/or severe physical diseases
  4. 18-65years old

Exclusion Criteria:

  1. In pregnancy,brain and other severe medical conditions
  2. Psychoactive substance abuse
  3. Had a diagnosis of bipolar disorder

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): NCT02346682


Locations
China, Zhejiang
Tongde hospital of zhejiang province Recruiting
Hangzhou, Zhejiang, China, 310012
Contact: Feng Bin, bachelor    +860571 89972003    fengbintd@aliyun.com   
Contact: Zhang jianmin, Ph.d    +86057189972008    jianmin.3.zhang@kcl.ac.uk   
Principal Investigator: Zhang-jin Zhang, Professor         
Principal Investigator: Bin Feng, Professor         
Sub-Investigator: Jiong Chen, physician         
Sub-Investigator: ya-ping Li, Professor         
Principal Investigator: Jin-bao Pu, researcher         
Sub-Investigator: Wei-qing Liang, researcher         
Sub-Investigator: Hong-xia Zhang, Radiologist         
Sub-Investigator: Wen-song Chen, physician         
Sub-Investigator: Zheng-xin Chen, physician         
Sub-Investigator: Cheng-yu Gu, physician         
Sub-Investigator: Pei-rong Wang, physician         
Sub-Investigator: Yong-chun Ma, physician         
Sub-Investigator: Yin Zhang, physician         
Sub-Investigator: Chun-yu Yang, physician         
Sub-Investigator: Bao-ping Xing, physician         
Sub-Investigator: Wei-dong Jin, physician         
Sub-Investigator: Yuan-Yuan Zhang, physician         
Sponsors and Collaborators
Zhejiang Provincial Tongde Hospital
The University of Hong Kong
Investigators
Study Director: Lan-ying Liu, Master Zhejiang Provincial Tongde Hospital

Responsible Party: Lan-ying Liu, associate chief physician, Zhejiang Provincial Tongde Hospital
ClinicalTrials.gov Identifier: NCT02346682     History of Changes
Other Study ID Numbers: zjsltdyy2014009
8140151401 ( Other Grant/Funding Number: National Natural Science Foundation of China )
First Posted: January 27, 2015    Key Record Dates
Last Update Posted: April 27, 2015
Last Verified: April 2015

Keywords provided by Lan-ying Liu, Zhejiang Provincial Tongde Hospital:
major depression disorder
biochemistry
TCM diagnosis
Neurological
metabonomics
neuroimaging

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Disease
Pathologic Processes
Behavioral Symptoms
Mood Disorders
Mental Disorders
Venlafaxine Hydrochloride
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs