BridgeMD
New treatment option for Depression
Official title Ganoderma Spores Modulate the Gut-Brain Axis
ClinicalTrials.gov ID: NCT07524777
What this study is testing
- What it's testing
- This study aims to investigate whether Sporoderm-removed Ganoderma lucidum spore powder (RGLS) ameliorates depression in thyroid cancer patients through gut-brain axis modulation, and to elucidate the underlying microbial and metabolic mechanisms. This 3-month randomized, double-blind, placebo-controlled trial will enroll 300 postoperative papillary thyroid carcinoma patients with depressive symptoms (HAMD-24 ≥ 8).
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80, women only
You may be able to join if
- Outpatients at Zhejiang Cancer Hospital with histologically confirmed papillary thyroid carcinoma (post-surgery) and depressive symptoms (HAMD-24...
- Han Chinese ethnicity.
- No history of depression or other psychiatric disorders.
- Age 18-80 years.
- Female.
You likely can't join if
- Suffering from other gastrointestinal system diseases.
- History of gastrointestinal surgery prior to intervention.
- Including those with other concurrent malignancies requiring chemotherapy, radiotherapy, biological therapy, or traditional Chinese medicine...
- Received antibiotic treatment or microecological modulators within 3 months prior to intervention.
- Acute intestinal obstruction.
- Patients who are currently taking antidepressant medication, or those whom the investigators judge require immediate initiation of antidepressant...
See the full eligibility criteria
- Outpatients at Zhejiang Cancer Hospital with histologically confirmed papillary thyroid carcinoma (post-surgery) and depressive symptoms (HAMD-24 score ≥ 8, confirmed by a clinical psychologist).
- Han Chinese ethnicity.
- No history of depression or other psychiatric disorders.
- Age 18-80 years.
- Female.
- Suffering from other gastrointestinal system diseases.
- History of gastrointestinal surgery prior to intervention.
- Including those with other concurrent malignancies requiring chemotherapy, radiotherapy, biological therapy, or traditional Chinese medicine treatment.
- Received antibiotic treatment or microecological modulators within 3 months prior to intervention.
- Acute intestinal obstruction.
- Patients who are currently taking antidepressant medication, or those whom the investigators judge require immediate initiation of antidepressant medication treatment.
- Organic brain diseases, brain trauma.
- History of psychiatric disorders, use of psychoactive substances (e.g., drugs).
- Severe liver or kidney dysfunction.
- Pregnancy or lactation.
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.