Completed PHASE1 INTERVENTIONAL 2-arm 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)

Sponsor: Luye Pharma Group Ltd.

Conditions Major Depressive Disorder

Interventions LY03005 extended-release tablets 120 mg group LY03005 extended-release tablets 160 mg group LY03005 extended-release tablets 40 mg LY03005 extended-release tablets 80 mg group Placebo group

Updated 4 times since 2019 Last updated: Dec 21, 2018 Started: Oct 9, 2015 Primary completion: Oct 31, 2015 Completion: Oct 31, 2015

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE1 trial investigates Major Depressive Disorder and is currently completed. Luye Pharma Group Ltd. leads this study, which shows 4 recorded versions since 2015 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

Change History

4 versions recorded

Sep 2024 — Present [monthly]

Completed PHASE1
Jul 2024 — Sep 2024 [monthly]

Completed PHASE1
Jan 2021 — Jul 2024 [monthly]

Completed PHASE1
Jan 2019 — Jan 2021 [monthly]

Completed PHASE1

First recorded

Oct 2015

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Luye Pharma Group Ltd.
Shandong Luye Pharmaceutical Co., Ltd.

Data source: Luye Pharma Group Ltd.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• Haidian District,, China