NCT03785652

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

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 260 (actual)
• Sponsor: Luye Pharma Group Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	LY03005 extended-release tablets 40 mg	LY03005 extended-release tablets 40 mg group :40mg/day，orally once a day, at a regular morning time on an empty stomach or after breakfas
DRUG	LY03005 extended-release tablets 80 mg group	LY03005 extended-release tablets 80 mg group : 80mg/day，orally once a day, at a regular morning time on an empty stomach or after breakfast
DRUG	LY03005 extended-release tablets 120 mg group	LY03005 extended-release tablets 120 mg group : 120mg/day，orally once a day, at a regular morning time on an empty stomach or after breakfast
DRUG	LY03005 extended-release tablets 160 mg group	LY03005 extended-release tablets 160 mg group : 160mg/day，orally once a day, at a regular morning time on an empty stomach or after breakfast
DRUG	Placebo group	Placebo group : Placebo ，orally once a day, at a regular morning time on an empty stomach or after breakfast

Timeline

• Start date: 2015-10-09
• Primary completion: 2015-10-31
• Completion: 2015-10-31
• First posted: 2018-12-24
• Last updated: 2018-12-24

Locations

1 site across 1 country: China