The Study of Antidepressant Properties and Safety of Fer-01(Soline®) on the Patients With Depression

Study Overview
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Brief Summary
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Considering the potential modulatory effects of Salvia divinorum, Lycium, Chenpi and Dihuang supplementation on mood, this study is a clinical study of Soline® (product mixed with Salvia divinorum, Lycium, Chenpi and Dihuang ) supplementation to investigate the effect of attenuating the occurrence of depression. The study will enroll 100 patients who meet the inclusion and exclusion criteria. The trial will be concluded when a total of evaluable 80 patients (40 patients in each treatment group).

Detailed Description
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Depression is one of the major metal disorders associated with symptoms such as regular negative moods, decreased physical activities, feeling of helplessness, and cognitive deficits. According to the seminal burden of disease study by World Health Organization (WHO) has predicted that by 2030 depression will be the second leading cause of disease. The Diagnostic and Statistical Manual of Mental Disorders (DSM) is the American Psychiatric Association's standard reference for psychiatry which includes over 400 different definitions of mental disorders. Selective and reversible monoamine oxidase inhibitor, selective serotonin reuptake inhibitors or serotonin and noradrenaline reuptake inhibitors are the typical antidepressants usually. Unfortunately, current drug therapies for depression are not ideal. Most of the drugs are synthetic nitrogen-bearing compounds which have inevitably some serious adverse-effects such as causing cardiovascular disease, insomnia and ovarian teratomas. Hence, there is an urgent need for the research and development of more effective antidepressants without any/ with minor adverse-effect. Up to the present, many Chinese medicinal plants have been successfully used to treat sentimental diseases, which is similar to depression in the Western medicine. Shamans of the Mazatec people of Oaxaca, Mexico have used Salvia divinorum for at least centuries in ethnomedical practices including spiritual healing and divinorum. Salvia divinorum contains the known psychoactive constituent salvinorin A, which is a trans-neoclerodancediterpenoid and a к-opioid agonist with no activity at the 5-HT2A serotonin receptor, making it an ideal agent for antidepressant. Salvia divinorum use occurring in Europe and Japan, and survey research suggests that user claim positive after-effects. Lycium, Chenpi ( Citrus reticulate Blanco ) and Dihuang ( Rehmannia glutinosa ) were widely used in the vast majority of Chinese medicine prescription to treat mental disease, for example, Lily Bulb Decoction to Preserve the Lung ( Lycium and Dihuang ) from Analytic Collection of Medical Formula , Spirit-quieting Decoction ( Chenpi ) form Restoring Health from Tens of Thousands of Diseases. Considering the potential modulatory effects of Salvia divinorum, Lycium, Chenpi and Dihuang supplementation on mood, this study is a clinical study of Soline® (product mixed with Salvia divinorum, Lycium, Chenpi and Dihuang ) supplementation to investigate the effect of attenuating the occurrence of depression.

Official Title
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Phase IIa Study of Antidepression Use Natural Plants Extracted of Soline Capsule.

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Other: Soline capsule


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: •Clinical diagnosis of major depressive disorder Exclusion Criteria: Pregnancy and nursing Schizophrenia spectrum disorder Manic depressive disorder Bipolar disorder Anxiety Disorder Abnormal biochemistry analysis value:( AST and ALT≧triple the upper limit of normal)； Serum creatinine>2mg/dl BUN>40mg/dL Total bilirubin>2.0mg/dL Hematocrit<30 White blood count≧15000 High sensitivity to this product The diseases will influence of results: pulmonary tuberculosis, uncontrolled diabetes, uncontrolled hypertension, serious infection and critical cardiovascular, liver, kidney disease. Alcohol abuse or drug abuse Attended the other study in last 4 weeks Attempted suicide or self-injurious

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Soline capsule<br>Salvia divinorum, Lycium, Chenpi and Dihuang | Other: Soline capsule<br> <br> * Other names: prozac;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DSM-IV | diagnosis of major depressive disorder according to DSM-Ⅳ has change | Day 1 and up to 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| analysis of inflammation cytokine | Laboratory examination parameters ( TNF-a,IL-6, TGF-b1) | Day 1 and up to 6 weeks | 
| analysis of basic biochemical | The incidence of hepatic and renal adverse events(GOT, GTP, BUN, creatinine...) | Day 1 and up to 6 weeks | 
| Fatty acid composition | Fatty acid composition is measure with gas chromatography. | Day 1 and up to 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TG, TC, HDL, LDL, Albumin, Hemoglobin, Hematocrit, Uric acid, Sodium, Potassium, Calcium