NCT04509882

Bear Bile Pill as add-on the Treatment of MDD

Add-on Study of Bear Bile Pill for Patients With Major Depressive Disorder (MDD)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Shanghai Mental Health Center · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is a single-center, double blind, randomized, placebo-controlled, parallel group study of bear bile pill, as add-on therapy in MDD patients conducted in Shang Hai Mental Health Center. The purpose of this study is to determine the efficacy and safety of bear bile pill in reducing symptoms of depression in Major Depressive Disorder (MDD)patients with inadequate response to current antidepressant therapy. Following a screening period, subjects who meet the entry criteria will be randomized to treated with either placebo or 450mg bear bile pill three times daily for 8 weeks.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	bear bile pill	Bear bile pill (15 pills) taken orally three times a day after meals with water.
DRUG	placebo	Placebo(15 pills) taken orally three times a day after meals with water.

Timeline

• Start date: 2020-10-30
• Primary completion: 2022-03-31
• Completion: 2022-03-31
• First posted: 2020-08-12
• Last updated: 2020-08-12

Locations

1 site across 1 country: China