A Phase 4 interventional study of venlafaxine in Severe Major Depression Disorder, sponsored by Zhejiang Provincial Tongde Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-04-27.
Sponsored by Zhejiang Provincial Tongde Hospital · Phase 4, Interventional, and Diagnostic
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.
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.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's planned enrollment of 75 is below the median of 84 across 6,720 interventional studies indexed under Depression.
Browse Depression studies →Zhejiang Provincial Tongde Hospital is the lead sponsor of 7 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
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
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 including the healthy volunteer None drug The biomarkers of neurobiochemistry, metabonomics and neuroimaging would be tested at the baseline .
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
Brain neuroimaging
Diffusion Tensor Imaging(DTI) is used to detect changes in FA maps of brain white matter fiber in major depressive patients
Time frame: 2 years
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.
Time frame: 2 years
Neurochemical tests
High Performance Liquid Chromatography (HPLC) is used to detect blood samples for: 5-HT, NE, DA, 5-HTAA, and HVA.
Time frame: 2 years
This study is status unknown, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.
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Zhejiang Provincial Tongde Hospital