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

NCT02346682 | Unknown Phase 4 DMC

• 2 other identifiers: zjsltdyy20140098140151401
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Severe Major Depression Disorder

Keywords

major depression disorder; biochemistry; TCM diagnosis; Neurological; metabonomics; neuroimaging

Outcome Measures

Primary Outcomes (1)

• Brain neuroimaging

  Diffusion Tensor Imaging(DTI) is used to detect changes in FA maps of brain white matter fiber in major depressive patients

  2 years

Secondary Outcomes (1)

• Biochemical tests

  2 years

Other Outcomes (1)

• Neurochemical tests

  2 years

Study Arms (3)

LDQS group

ACTIVE COMPARATOR

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

DBHS group

ACTIVE COMPARATOR

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

the normal controls group

NO INTERVENTION

The normal controls group including the healthy volunteer None drug The biomarkers of neurobiochemistry, metabonomics and neuroimaging would be tested at the baseline .

Interventions

venlafaxine DRUG

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.

Also known as: clonazepam

DBHS group; LDQS group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• The severity of the symptoms is moderate or severe, confirmed by a 35 or greater of Hamilton Rating Scale for Depression(HAMD) score
• Absence of brain and/or severe physical diseases
• years old

You may not qualify if:

• In pregnancy，brain and other severe medical conditions
• Psychoactive substance abuse
• Had a diagnosis of bipolar disorder

Sponsors & Collaborators

• Zhejiang Provincial Tongde Hospital: lead
• The University of Hong Kong: collaborator

Study Sites (1)

Tongde hospital of zhejiang province

Hangzhou, Zhejiang, 310012, China

RECRUITING

Related Publications (2)

• Liu LY, Xu XP, Luo LY, Zhu CQ, Li YP, Wang PR, Zhang YY, Yang CY, Hou HT, Cao YL, Wang G, Hui ES, Zhang ZJ. Brain connectomic associations with traditional Chinese medicine diagnostic classification of major depressive disorder: a diffusion tensor imaging study. Chin Med. 2019 Apr 11;14:15. doi: 10.1186/s13020-019-0239-8. eCollection 2019.

  PMID: 31044001 DERIVED

• Liu LY, Zhang HJ, Luo LY, Pu JB, Liang WQ, Zhu CQ, Li YP, Wang PR, Zhang YY, Yang CY, Zhang ZJ. Blood and urinary metabolomic evidence validating traditional Chinese medicine diagnostic classification of major depressive disorder. Chin Med. 2018 Oct 25;13:53. doi: 10.1186/s13020-018-0211-z. eCollection 2018.

  PMID: 30386416 DERIVED

MeSH Terms

Conditions

Neurologic Manifestations

Interventions

Venlafaxine Hydrochloride; Clonazepam

Condition Hierarchy (Ancestors)

Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Phenethylamines; Ethylamines; Amines; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Lipids; Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Lan-ying Liu, Master

  Zhejiang Provincial Tongde Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate chief physician

Study Record Dates

• First Submitted: December 18, 2014
• First Posted: January 27, 2015
• Study Start: February 1, 2015
• Primary Completion: June 1, 2017
• Study Completion: December 1, 2017
• Last Updated: April 27, 2015

Record last verified: 2015-04

Locations

CN (1)