Dose-Finding Clinical Trial to Evaluate the Efficacy and Safety of LY03005 Extended-release Tablets in the Treatment of Major Depressive Disorder (MDD)
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 1

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.
    

Intervention name(s): LY03005 extended-release tablets 40 mg; LY03005 extended-release tablets 80 mg group; LY03005 extended-release tablets 120 mg group; LY03005 extended-release tablets 160 mg group; Placebo group
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 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; 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; 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; 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; Placebo group :
Placebo ，orally once a day, at a regular morning time on an empty stomach or after breakfast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment