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

Severe Major Depression Disorder Clinical Trial

— NMNTDM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02346682
• Other study ID #: zjsltdyy2014009
• Secondary ID: 8140151401
• Status: Recruiting
• Phase: Phase 4
• First received: December 18, 2014
• Last updated: April 23, 2015
• Start date: February 2015
• Est. completion date: December 2017

Study information

• Verified date: April 2015
• Source: Zhejiang Provincial Tongde Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: National Natural Science Foundation
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: December 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Severe Major Depression Disorder

Intervention

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.

Locations

Country	Name	City	State
China	Tongde hospital of zhejiang province	Hangzhou	Zhejiang

Sponsors (2)

Lead Sponsor	Collaborator
Zhejiang Provincial Tongde Hospital	The University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Neurochemical tests	High Performance Liquid Chromatography (HPLC) is used to detect blood samples for: 5-HT, NE, DA, 5-HTAA, and HVA.	2 years	Yes
Primary	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	Yes
Secondary	Biochemical tests	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.	2 years	Yes