A Study to Evaluate the Efficacy and Safety of Ansofaxine Hydrochloride Extended-release Tablets in the Treatment of Major Depressive Disorder (MDD)

A Phase III, A Multicenter, Double-blind, Randomized, Placebo-controlled Study Verify the Efficacy and Safety of Ansofaxine Hydrochloride Extended-release Tablets for Major Depressive Disorder

The purpose of this study is to determine if LY03005 is effective and safe in improve MADRS score, as compared to placebo (no medicine) in participants with Major Depressive Disorder (MDD)

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder (MDD)
• Intervention / Treatment: Drug: LY03005 extended-release tablet; Drug: Placebo

Detailed Description

The study consisted of two periods: a screening period of 1 week and a double-blind treatment period (8 weeks). After the screening period, 588 enrolled subjects were randomized into one of 3 study groups in the 1:1:1 ratio, 2 LY03005 treatment groups with different dose or 1 placebo group. Subjects were given investigatory drug or placebo according to the protocol, followed up at the end of 1, 2, 4 6, and 8 weeks.

• Study Type: Interventional
• Enrollment (Actual): 558
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • The Sixth Hospital of Peking University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male or female aged 18 to 65 years subjects from outpatients;
2. Subjects currently meet the Diagnostic and Statistical Manual of Manual Disorders, fifth Edition(DSM-5) criteria for MDD with either single or recurrent episodes (296.2/296.3) without psychotic characteristics;
3. Subjects has a total score of the Montgomery- Åsberg Depression Scale (MADRS) ≥26 points at screening;
4. Subjects has a clinical Global Impression -severity illness (CGI-S) score≥4 points at screening

Exclusion Criteria:

1. Allergic or known to be allergic to venlafaxine and desvenlafaxine;
2. Subjects with MDD who were not responsive to the previous venlafaxine treatment with sufficient amount and duration and to at least two different mechanisms of action antidepressants with adequate amount and duration in the past;
3. There is a clear suicide attempt or behavior and score of the 10th item (suicidal ideation) in MADRS scale is 4 points or greater;
4. Pregnant or lactating women,women who have a planned pregnancy in the near future;
5. Subjects meet the diagnostic criteria for other psychotic disorders(except for MDD) in DSM-5, such as Schizophrenia Spectrum and Other Psychotic Disorders, Bipolar and Related Disorders, Obsessive-Compulsive and related Disorders, post-traumatic stress disorder, separation disorders, anorexia nervosa or bulimia and personality disorder;
6. Subjects who meet the diagnostic criteria for substance or alcohol abuse (excluding nicotine or caffeine) 6 months prior to the screening;
7. MDD secondary to other mental illnesses or physical illnesses;
8. Those with a history of seizures (except for convulsions caused by febrile seizures in children).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LY03005 extended-release tablets 80 mg group; orally once a day	Drug: LY03005 extended-release tablet; orally once a day
Experimental: LY03005 extended-release tablets 160 mg group; orally once a day	Drug: LY03005 extended-release tablet; orally once a day
Placebo Comparator: Placebo group; orally once a day	Drug: Placebo; orally once a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Montgomery- Åsberg Depression Rating Scale(MADRS)	Changes from baseline in the 10-items Montgomery- Åsberg Depression Scales (MADRS) total scores at the end of treatment. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).	8 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
17 items Hamilton Depression Scales (HAM-D17)	Changes from baseline in the 17 items Hamilton Depression Scales (HAM-D17) total scores at the end of treatment. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, and weight loss). Nine items are scored on a 3 point scale (0=none/absent to 2=most severe) and 8 items are scored on a 5 point scale (0=none/absent to 4=most severe) for a maximum total score of 50; higher score indicates more depression.	8 Weeks

Collaborators and Investigators

• Sponsor: Luye Pharma Group Ltd.
• Investigators: Principal Investigator: Hongyan Zhang, Peking University Sixth Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2018
• Primary Completion (Actual): December 24, 2020
• Study Completion (Actual): December 24, 2020

Study Registration Dates

• First Submitted: April 8, 2021
• First Submitted That Met QC Criteria: April 20, 2021
• First Posted (Actual): April 21, 2021

Study Record Updates

• Last Update Posted (Actual): November 15, 2021
• Last Update Submitted That Met QC Criteria: November 11, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: LY03005/CT-CHN-305

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No