NCT02380066

Proof Of Concept Study of Anyu Peibo in the Treatment of Major Depressive Disorder(MDD): a Randomized, Double-Blind, Placebo-Paralleled,Dose-Finding, Multicenter Clinical Trial

Completed Phase 2 Last updated 29 December 2019

What this trial tests

Phase 2 trial testing Anyu Peibo in Major Depressive Disorder (MDD) in 120 participants. Completed in 1 January 2017.

Timeline

1 March 2015

Primary endpoint
1 March 2016

1 January 2017

Quick facts

Lead sponsor	Shanghai Mental Health Center
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	120
Start date	1 March 2015
Primary completion	1 March 2016
Estimated completion	1 January 2017
Sites	6 locations across China

Drugs / interventions tested

• Anyu Peibo — full drug profile →

Conditions studied

• Major Depressive Disorder (MDD) — all drugs for Major Depressive Disorder (MDD) →

Sponsor

Shanghai Mental Health Center — full company profile →

Who can join

Adults 18 to 65, any sex, with Major Depressive Disorder (MDD). 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 MADRS scale
  Time frame: 6 weeks

Sponsor's own description

The purpose of this study is to determine whether Anyu Peibo Capsule in different doses are effective in the treatment of Depression.

And to explore the preliminary information of safety and efficacy of Anyu Peibo Capsule in the Chinese Patients with Depression.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. 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