Dose-Finding Clinical Trial to Evaluate the Efficacy and Safety of LY03005 Extended-release Tablets in the Treatment of Major Depressive Disorder (MDD)

Major Depressive Disorder Clinical Trial

Official title: Multicenter,Randomized,Double-blind,Placebo,Parallel-controlled,Dose-Finding Clinical Trial to Evaluate the Efficacy and Safety of LY03005 Extended-release Tablets in the Treatment of Major Depressive Disorder (MDD)

Status Completed

Clinical Trial Summary

This study was a multicenter, randomized, double-blind, placebo, parallel-controlled, dose-finding Phase II clinical trial to find the optimal dose of LY03005 Extended-release Tablets for the treatment of MDD and to evaluate the preliminary efficacy and safety, providing a basis for the design of phase III clinical trials and the determination of dosing regimens.

Clinical Trial Description

The study consisted of two periods: a screening and washout period of 2 weeks (recommended 8 days) and a double-blind treatment period (6 weeks). The first period is the screening and washing period, the longest is 14 days and the shortest is 8 days (recommended 8 days), in which the enrolled MDD subjects will start a one-week placebo wash period and receive prescribed a placebo, 2 pills once a day for 7 consecutive days. The second period was a double-blind treatment period of 6 weeks. After the placebo washout period, 260 enrolled subjects were randomized into one of 5 study groups in the 1:1:1:1:1 ratio, 4 LY03005 Extended-release Tablets treatment groups with different dose or 1 placebo group. Subjects were given investigatory drug or placebo according to the protocol, 4 pills once a day and followed up at the end of 1, 2, 4 and 6 weeks.

Effectiveness of the investigational drug was evaluated using 17 Hamilton Depression Scale (HAM-D17), Montgomery-Asberg Depression Scale (MADRS), Hamilton Anxiety Scale (HAMA), Clinical Global Impression Scale (CGI) and Visual Analog Scale—Pain intensity (VAS-PI) scores. Safety of the treatment was evaluated by adverse events, vital signs, laboratory measurements (blood routine, urine routine, blood biochemistry and serology), 12-lead ECG, physical examination, the Arizona Sexual Experience Scale (ASEX) and the Columbia-Suicide Severity Rating Scale (C-SSRS) scores. ;

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder

• NCT number: NCT03785652
• Study type: Interventional
• Source: Luye Pharma Group Ltd.
• Status: Completed
• Phase: Phase 1
• Start date: October 9, 2015
• Completion date: October 31, 2015