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

September 9, 2012 updated by: Taipei Medical University Hospital

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 100
        • Recruiting
        • Taipei Mecical University Hospital
        • Contact:
        • Sub-Investigator:
          • Chih-Chiang Chiu, Ph.D
        • Sub-Investigator:
          • Hsin-Chien Lee, Ph.D
        • Principal Investigator:
          • Shih-Yi Huang, Ph.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

community sample, residents of Taiwan

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Soline capsule
Salvia divinorum, Lycium, Chenpi and Dihuang
Other: Soline capsule
Other Names:
  • prozac

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Medical University Hospital

Collaborators

Taipei Medical University Shuang Ho Hospital

Investigators

  • Principal Investigator: Shih-Yi Huang, Ph.D, Taipei Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Anticipated)

July 1, 2013

Study Completion (Anticipated)

November 1, 2013

Study Registration Dates

First Submitted

August 15, 2012

First Submitted That Met QC Criteria

August 20, 2012

First Posted (Estimate)

August 23, 2012

Study Record Updates

Last Update Posted (Estimate)

September 11, 2012

Last Update Submitted That Met QC Criteria

September 9, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Fer-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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