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

Phase 4

• Conditions: Severe Major Depression Disorder
• Interventions: Drug: venlafaxine

• Registration Number: NCT02346682
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2014-12-18
• Study First Submitted QC: 2015-01-20
• Study First Posted: 2015-01-27
• Study Start: 2015-02
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-23
• Last Update Posted: 2015-04-27
• Primary Completion: 2017-06
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 75

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LDQS group	venlafaxine	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.
DBHS group	venlafaxine	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 .

Primary Outcome Measures

Name	Time	Method
Brain neuroimaging	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

Name	Time	Method
Biochemical tests	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.

Trial Locations

Locations (1)

Tongde hospital of zhejiang province; 🇨🇳 Hangzhou, Zhejiang, China