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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Taipei Medical University Hospital.
Recruitment status was  Recruiting
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
  Purpose

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).


Condition Intervention
Major Depressive Disorder
Other: Soline capsule

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Phase IIa Study of Antidepression Use Natural Plants Extracted of Soline Capsule.

Resource links provided by NLM:


Further study details as provided by Taipei Medical University Hospital:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 1
Study Start Date: September 2012
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Soline capsule
Salvia divinorum, Lycium, Chenpi and Dihuang
Other: Soline capsule
Other Name: prozac

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.

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

community sample, residents of Taiwan

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01671124

Locations
Taiwan
Taipei Mecical University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Yu-Ru Guo, master    886227361661 ext 6549    dinyty@hotmail.com   
Sub-Investigator: Chih-Chiang Chiu, Ph.D         
Sub-Investigator: Hsin-Chien Lee, Ph.D         
Principal Investigator: Shih-Yi Huang, Ph.D         
Sponsors and Collaborators
Taipei Medical University Hospital
Taipei Medical University Shuang Ho Hospital
Investigators
Principal Investigator: Shih-Yi Huang, Ph.D Taipei Medical University
  More Information

No publications provided

Responsible Party: Taipei Medical University Hospital
ClinicalTrials.gov Identifier: NCT01671124     History of Changes
Other Study ID Numbers: Fer-01
Study First Received: August 15, 2012
Last Updated: September 9, 2012
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Taipei Medical University Hospital:
TG
TC
HDL
LDL
Albumin
Hemoglobin
Hematocrit
Uric acid
Sodium
Potassium
Calcium

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2014