drugset / Trial / NCT03785652
Dose-Finding Clinical Trial to Evaluate the Efficacy and Safety of LY03005 Extended-release Tablets in the Treatment of Major Depressive Disorder (MDD)
Phase 1
Completed
260 enrolled
Luye Pharma Group Ltd.
Shandong Luye Pharmaceutical Co., Ltd. · collab
RandomizedParallel-groupDouble-blindTreatment
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.
Timeline
- Start
- 2015-10-09
- Primary completion
- 2015-10-31
- Completion
- 2015-10-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Toludesvenlafaxine | Small molecule | 40 mg | Oral |
| Subject | Toludesvenlafaxine | Small molecule | 80 mg | Oral |
| Subject | Toludesvenlafaxine | Small molecule | 120 mg | Oral |
| Subject | Toludesvenlafaxine | Small molecule | 160 mg | Oral |