NCT03785652 - Dose-Finding Clinical Trial to Evaluate the Efficacy and Safety of LY03005 Extended-release Tablets in the Treatment of Major Depressive Disorder (MDD) | Biotech Hunter

Enrollment

260

Participants

Timeline

Start Date

October 9, 2015

Primary Completion Date

October 31, 2015

Study Completion Date

October 31, 2015

Conditions

Major Depressive Disorder

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"

Trial Locations (1)

Approval Letter of Ethics Committee of The Sixth Hospital of Peking University, Haidian District,

All Listed Sponsors

collaborator

Shandong Luye Pharmaceutical Co., Ltd.

INDUSTRY

lead

Luye Pharma Group Ltd.

INDUSTRY