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OpenTrials
Completed

NCT Number: NCT04002219

Efficacy Evaluation of the Mushroom Beverage on Emotion Regulation

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.

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Key information

Conditions

Inflammation, Brain Brain Diseases Central Nervous System Diseases Emotional Problem Encephalitis Nervous System Diseases Neuroinflammatory Diseases

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

China Medical University Hospital

Taichung, 404, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

beverage containing mushroom-extracts

Dietary Supplement

Subjects recruited from both arms will receive treatment and be followed up clinically for 8 weeks.

Primary outcomes

  1. Change of subjective depressive symptoms

    Time frame: 8 weeks

    Measured by Beck Depression Inventory-II

  2. Change of objective depressive symptoms

    Time frame: 8 weeks

    Measured by Hamilton Rating Scale for Depression

  3. 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.

  4. Cortisol level

    Time frame: 8 weeks

    Measured as a stress-related biomarker

Sponsors and collaborators

Lead sponsor

National Science and Technology Council, Taiwan

Other Gov

Collaborators

  • National Taiwan University

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Jun 28, 2019
Registry last updated
Oct 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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