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

NCT03785652 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2018-12-24

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Shandong Luye Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • Luye Pharma Group Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-09
Primary Completion
2015-10-31
Completion
2015-10-31

Countries

  • China

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03785652 on ClinicalTrials.gov