NCT04210973

Efficacy and Safety Study of Anyu Peibo in the Treatment of Major Depressive Disorder(MDD): a Ⅲ Randomized, Double-Blind, Placebo-Paralleled, Multicenter Clinical Trial

Status unknown Phase 3 Last updated 11 May 2020

What this trial tests

Phase 3 trial testing Anyu Peibo in Major Depressive Disorder in 266 participants. Status unknown.

Timeline

23 January 2020

Primary endpoint
1 December 2020

1 May 2021

Quick facts

Lead sponsor	Shanghai Mental Health Center
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	266
Start date	23 January 2020
Primary completion	1 December 2020
Estimated completion	1 May 2021
Sites	15 locations across China

Drugs / interventions tested

• Anyu Peibo — full drug profile →
• Placebo

Conditions studied

• Major Depressive Disorder — all drugs for Major Depressive Disorder →

Sponsor

Shanghai Mental Health Center — full company profile →

Who can join

Adults 18 to 65, any sex, with Major Depressive Disorder. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• The change of total score from baseline in Montgomery Asberg Depression Rating Scale （MADRS）
  Time frame: 8 weeks
  the minimum and maximum values of MADRS are from 0 to 60, and higher scores mean a worse outcome

Sponsor's own description

The purpose of this study is to evaluate the efficacy and safety of Anyu Peibo Capsule comparing with placebo in the treatment of Chinese Patients with Depression.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. The efficacy and safety of Anyu Peibo Capsule in the treatment of patients with major depressive disorder in China: study protocol for a randomized placebo-controlled trial.
   Huang J, Yu Y, Jiang Y, Chen W, et al · · 2021 · cited 1× · PMID 34479619 · DOI 10.1186/s13063-021-05550-9
2. A 6-week, phase IIb, randomized, double-blind, placebo-controlled trial of Anyu Peibo capsules for the treatment of major depressive disorder in adults.
   He S, Yu Y, Huang J, Yin J, et al · · 2023 · PMID 38022835 · DOI 10.1177/20451253231212342
3. The efficacy and safety of Anyu Peibo Capsule in the treatment of patients with major depressive disorder in China: study protocol for a randomized placebo-controlled trial
   Huang J, Yu Y, Jiang Y, Chen W, et al · · 2021 · DOI 10.21203/rs.3.rs-35463/v1