Inflammation, BrainNCT04002219
Efficacy Evaluation of the Mushroom Beverage on Emotion Regulation
A study testing beverage containing mushroom-extracts in people with Inflammation, Brain and Emotional Problem, run by National Science and Technology Council, Taiwan at 1 site in Taiwan.
Trial summary
Major Depression Disorder is one of the most common psychiatric disease and has affecting approximately 350 million people in the world. According to World Health Organization's report, it may be the first burden of disease in 2030. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Inflammation, Brain, Emotional Problem
- What is being tested?
- beverage containing mushroom-extracts
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jul 2019to 28 Feb 2020
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 21 -items Hamilton Rating Scale for Depression scores 8-17 points upon interview
- At least 2 weeks not taking antidepressants, antipsychotics or antiepileptics.
- Understand the whole process of the study and had signed the informed consent form
Who cannot join
- Had been diagnosed with severe mental disorder, schizophrenia, bipolar disorder, personality disorder, substance use disorder or alcohol use disorder, or other severe physical illness that is not expected to survive during the intervention period.
- Currently taking antidepressants or other medication that may impact the study.
- Expected to be non-adherent.
- Without sufficient data to confirm safety.
- Pregnant woman
- Allergic to fungal products.
- Currently taking MAO-inhibitors
Trial locations and contacts
1 site in 1 country.
About this study
Major Depression Disorder is one of the most common psychiatric disease and has affecting approximately 350 million people in the world. According to World Health Organization's report, it may be the first burden of disease in 2030. Due to the high morbidity and low acceptance in the treatment, it is necessary to find some nature compounds to prevent the disease.
Cordyceps militaris, one of the most treasure Chinese herbs in Asia, contains many kinds of component such as cordycepin, polysaccharide, mannitol. In winter, it appears as an worm in the soil, afterwards, it grows out of the soil and convert into grass in summer. A previous study has demonstrated that Cordyceps militaris has anti-depressive effect in mouse tail suspension test, and in this study we will explore its effect in human subjects.
- Conditions
- Inflammation, Brain, Emotional Problem
- Being tested
- beverage containing mushroom-extracts
- Medical subject headings
- Encephalitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
beverage containing mushroom-extractsDietary supplement
Subjects recruited from both arms will receive treatment and be followed up clinically for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Active arm | Experimental | Subjects will receive treatment with active beverage containing the active ingredient Receives: Dietary Supplement: beverage containing mushroom-extracts |
| Placebo arm | Placebo comparator | Subjects will receive treatment with placebo beverage not containing the active ingredient Receives: Dietary Supplement: beverage containing mushroom-extracts |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of subjective depressive symptoms
Measured by Beck Depression Inventory-II
Measured: 8 weeks
Change of objective depressive symptoms
Measured by Hamilton Rating Scale for Depression
Measured: 8 weeks
Change of somatic symptoms
Measured by Neurotoxicity Rating Scale, a 39-item self-report scale to evaluate the somatic symptoms such as anorexia, fatigue and pain; higher scores indicate higher severity.
Measured: 8 weeks
Cortisol level
Measured as a stress-related biomarker
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2019
- Study start1 Jul 2019
- Primary completion31 Dec 2019
- Study completion28 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammation, BrainStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A triple-blind, randomized-controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Science and Technology Council, Taiwan
- Sponsor type
- Other government
- Collaborators
- National Taiwan University
- Responsible party
- Principal investigator, Kuan-Pin, National Science and Technology Council, Taiwan
- Investigators
- Kuan-Pin Su, MD, PhD, Study director, China Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04002219
- Sponsor's protocol ID
- CMUH108-REC3-022
- Status last verified
- Oct 2022
- First submitted
- 20 Jun 2019
- Last updated
- 10 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The study has not yet fully discuss the plan for IPD opening.
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Evaluation of the Mushroom Beverage on Emotion Regulation
- ClinicalTrials.gov ID
- NCT04002219
- Acronym / sponsor ID
- CMUH108-REC3-022
- Conditions
- Inflammation, Brain, Emotional Problem
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- National Science and Technology Council, TaiwanOther government
- Collaborators
- National Taiwan University
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 28 Jun 2019 (actual)
- 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.
Major Depression Disorder is one of the most common psychiatric disease and has affecting approximately 350 million people in the world. According to World Health Organization's report, it may be the first burden of disease in 2030. Due to the high morbidity and low acceptance in the treatment, it is necessary to find some nature compounds to prevent the disease.
Cordyceps militaris, one of the most treasure Chinese herbs in Asia, contains many kinds of component such as cordycepin, polysaccharide, mannitol. In winter, it appears as an worm in the soil, afterwards, it grows out of the soil and convert into grass in summer. A previous study has demonstrated that Cordyceps militaris has anti-depressive effect in mouse tail suspension test, and in this study we will explore its effect in human subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A triple-blind, randomized-controlled trial
| Arm | Type | Receives |
|---|---|---|
| Active arm | Experimental | Dietary Supplement: beverage containing mushroom-extractsSubjects will receive treatment with active beverage containing the active ingredient |
| Placebo arm | Placebo comparator | Dietary Supplement: beverage containing mushroom-extractsSubjects will receive treatment with placebo beverage not containing the active ingredient |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 21 -items Hamilton Rating Scale for Depression scores 8-17 points upon interview
- At least 2 weeks not taking antidepressants, antipsychotics or antiepileptics.
- Understand the whole process of the study and had signed the informed consent form
Key exclusion criteria (7 listed)
- Had been diagnosed with severe mental disorder, schizophrenia, bipolar disorder, personality disorder, substance use disorder or alcohol use disorder, or other severe physical illness that is not expected to survive during the intervention period.
- Currently taking antidepressants or other medication that may impact the study.
- Expected to be non-adherent.
- Without sufficient data to confirm safety.
- Pregnant woman
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 |
|---|---|---|
| beverage containing mushroom-extractsSubjects recruited from both arms will receive treatment and be followed up clinically for 8 weeks. | Dietary supplement | Active arm, Placebo arm |
Primary outcome
Change of subjective depressive symptoms
Time frame: 8 weeks
Measured by Beck Depression Inventory-II
Change of objective depressive symptoms
Time frame: 8 weeks
Measured by Hamilton Rating Scale for Depression
Change of somatic symptoms
Time frame: 8 weeks
Measured by Neurotoxicity Rating Scale, a 39-item self-report scale to evaluate the somatic symptoms such as anorexia, fatigue and pain; higher scores indicate higher severity.
Cortisol level
Time frame: 8 weeks
Measured as a stress-related biomarker
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2022.
- Individual participant dataSharing planned: Undecided. The study has not yet fully discuss the plan for IPD opening.
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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.
Kuan-Pin Su, MD, PhD study director
China Medical University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing beverage containing mushroom-extracts in people with Inflammation, Brain and Emotional Problem, run by National Science and Technology Council, Taiwan 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 3 inclusion and 7 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: finished, as of the sponsor's last update on 10 Oct 2022. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of subjective depressive symptoms (time frame: 8 weeks). The study lists 4 primary outcomes in all. 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 10 Oct 2022.