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

This study is currently recruiting participants.
Verified August 2012 by Taipei Medical University Hospital
Sponsor:
Collaborator:
Taipei Medical University Shuang Ho Hospital
Information provided by (Responsible Party):
Taipei Medical University Hospital
ClinicalTrials.gov Identifier:
NCT01671124
First received: August 15, 2012
Last updated: September 9, 2012
Last verified: August 2012

August 15, 2012
September 9, 2012
September 2012
July 2013   (final data collection date for primary outcome measure)
DSM-IV [ Time Frame: Day 1 and up to 6 weeks ] [ Designated as safety issue: Yes ]
diagnosis of major depressive disorder according to DSM-Ⅳ has change
Same as current
Complete list of historical versions of study NCT01671124 on ClinicalTrials.gov Archive Site
  • analysis of inflammation cytokine [ Time Frame: Day 1 and up to 6 weeks ] [ Designated as safety issue: Yes ]
    Laboratory examination parameters ( TNF-a,IL-6, TGF-b1)
  • analysis of basic biochemical [ Time Frame: Day 1 and up to 6 weeks ] [ Designated as safety issue: Yes ]
    The incidence of hepatic and renal adverse events(GOT, GTP, BUN, creatinine...)
  • Fatty acid composition [ Time Frame: Day 1 and up to 6 weeks ] [ Designated as safety issue: Yes ]
    Fatty acid composition is measure with gas chromatography.
Same as current
Not Provided
Not Provided
 
The Study of Antidepressant Properties and Safety of Fer-01(Soline®) on the Patients With Depression
Phase IIa Study of Antidepression Use Natural Plants Extracted of Soline Capsule.

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).

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

community sample, residents of Taiwan

Major Depressive Disorder
Other: Soline capsule
Other Name: prozac
Soline capsule
Salvia divinorum, Lycium, Chenpi and Dihuang
Intervention: Other: Soline capsule
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1
November 2013
July 2013   (final data collection date for primary outcome measure)

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
Both
20 Years to 60 Years
No
Not Provided
Taiwan
 
NCT01671124
Fer-01
Yes
Taipei Medical University Hospital
Taipei Medical University Hospital
Taipei Medical University Shuang Ho Hospital
Principal Investigator: Shih-Yi Huang, Ph.D Taipei Medical University
Taipei Medical University Hospital
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP