Major Depressive DisorderNCT01671124
The Study of Antidepressant Properties and Safety of Fer-01(Soline®) on the Patients With Depression
An observational study of Major Depressive Disorder, run by Taipei Medical University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Soline capsule
- Type of treatment
- Pill or oral medicine
- How many people
- 1 participants
- Where
- 1 siteTaiwan
- Study dates
- Sep 2012to Nov 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: community sample, residents of Taiwan
Who may be able to join
- •Clinical diagnosis of major depressive disorder
Who cannot join
- 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)；
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Mecical University Hospital
Taipei, Taiwan, 100
Yu-Ru Guo, master, 886227361661 ext. 6549, dinyty@hotmail.com
Chih-Chiang Chiu, Ph.D
About this study
Official title: 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).
Read the 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.
- Conditions
- Major Depressive Disorder
- Being tested
- Soline capsule
- Keywords
- TG, TC, HDL, LDL, Albumin, Hemoglobin, Hematocrit, Uric acid, Sodium, Potassium, Calcium
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soline capsuleOther
Also called prozac
| Study group | Role | What they receive |
|---|---|---|
| Soline capsule | Salvia divinorum, Lycium, Chenpi and Dihuang Receives: Other: Soline capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
DSM-IV
diagnosis of major depressive disorder according to DSM-Ⅳ has change
Measured: Day 1 and up to 6 weeks
Secondary outcomes (3)
analysis of inflammation cytokine
Laboratory examination parameters ( TNF-a,IL-6, TGF-b1)
Measured: Day 1 and up to 6 weeks
analysis of basic biochemical
The incidence of hepatic and renal adverse events(GOT, GTP, BUN, creatinine...)
Measured: Day 1 and up to 6 weeks
Fatty acid composition
Fatty acid composition is measure with gas chromatography.
Measured: Day 1 and up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2012 (estimated)
- Study startSep 2012
- Primary completionJul 2013 (estimated)
- Study completionNov 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Taipei Medical University Shuang Ho Hospital
- Responsible party
- Sponsor
- Investigators
- Shih-Yi Huang, Ph.D, Principal investigator, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01671124
- Sponsor's protocol ID
- Fer-01
- Status last verified
- Aug 2012
- First submitted
- 15 Aug 2012
- Last updated
- 11 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IIa Study of Antidepression Use Natural Plants Extracted of Soline Capsule.
- ClinicalTrials.gov ID
- NCT01671124
- Acronym / sponsor ID
- Fer-01
- Conditions
- Major Depressive Disorder
- Keywords
- TG, TC, HDL, LDL, Albumin, Hemoglobin, Hematocrit, Uric acid
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Taipei Medical University HospitalUniversity, hospital or other
- Collaborators
- Taipei Medical University Shuang Ho Hospital
- Study start
- Sep 2012
- Primary completion
- Jul 2013 (estimated)
- Study completion
- Nov 2013 (estimated)
- First posted
- 23 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Soline capsule | – | Other: Soline capsuleSalvia divinorum, Lycium, Chenpi and Dihuang |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- community sample, residents of Taiwan
Key inclusion criteria (1 listed)
- •Clinical diagnosis of major depressive disorder
Key exclusion criteria (16 listed)
- Pregnancy and nursing
- Schizophrenia spectrum disorder
- Manic depressive disorder
- Bipolar disorder
- Anxiety Disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Soline capsuleAlso: prozac | Other | Soline capsule |
Primary outcome
DSM-IV
Time frame: Day 1 and up to 6 weeks
diagnosis of major depressive disorder according to DSM-Ⅳ has change
3 secondary outcomes
analysis of inflammation cytokine
Time frame: Day 1 and up to 6 weeks
analysis of basic biochemical
Time frame: Day 1 and up to 6 weeks
Fatty acid composition
Time frame: Day 1 and up to 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shih-Yi Huang, Ph.D principal investigator
Taipei Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Depressive Disorder, run by Taipei Medical University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DSM-IV (time frame: Day 1 and up to 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2012.