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

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01671124
• Other study ID #: Fer-01
• Status: Recruiting
• Phase: N/A
• First received: August 15, 2012
• Last updated: September 9, 2012
• Start date: September 2012
• Est. completion date: November 2013

Study information

• Verified date: August 2012
• Source: Taipei Medical University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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).

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1
• Est. completion date: November 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Intervention

Other:
• Soline capsule

Locations

Country	Name	City	State
Taiwan	Taipei Mecical University Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
Taipei Medical University Hospital	Taipei Medical University Shuang Ho Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DSM-IV	diagnosis of major depressive disorder according to DSM-? has change	Day 1 and up to 6 weeks	Yes
Secondary	analysis of inflammation cytokine	Laboratory examination parameters ( TNF-a,IL-6, TGF-b1)	Day 1 and up to 6 weeks	Yes
Secondary	analysis of basic biochemical	The incidence of hepatic and renal adverse events(GOT, GTP, BUN, creatinine...)	Day 1 and up to 6 weeks	Yes
Secondary	Fatty acid composition	Fatty acid composition is measure with gas chromatography.	Day 1 and up to 6 weeks	Yes