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

NCT04853407 | Completed Phase 3

• 1 other identifier: LY03005/CT-CHN-305
• Study Type: interventional
• Target: 558
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Conditions

Major Depressive Disorder (MDD)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 17 items Hamilton Depression Scales (HAM-D17)

  8 Weeks

Study Arms (3)

LY03005 extended-release tablets 80 mg group

EXPERIMENTAL

orally once a day

Drug: LY03005 extended-release tablet

LY03005 extended-release tablets 160 mg group

EXPERIMENTAL

orally once a day

Drug: LY03005 extended-release tablet

Placebo group

PLACEBO COMPARATOR

orally once a day

Drug: Placebo

Interventions

LY03005 extended-release tablet DRUG

orally once a day

LY03005 extended-release tablets 160 mg group; LY03005 extended-release tablets 80 mg group

Placebo DRUG

orally once a day

Placebo group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female aged 18 to 65 years subjects from outpatients;
• 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;
• Subjects has a total score of the Montgomery- Åsberg Depression Scale (MADRS) ≥26 points at screening;
• Subjects has a clinical Global Impression -severity illness (CGI-S) score≥4 points at screening

You may not qualify if:

• Allergic or known to be allergic to venlafaxine and desvenlafaxine;
• 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;
• There is a clear suicide attempt or behavior and score of the 10th item (suicidal ideation) in MADRS scale is 4 points or greater;
• Pregnant or lactating women,women who have a planned pregnancy in the near future;
• 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;
• Subjects who meet the diagnostic criteria for substance or alcohol abuse (excluding nicotine or caffeine) 6 months prior to the screening;
• MDD secondary to other mental illnesses or physical illnesses;
• Those with a history of seizures (except for convulsions caused by febrile seizures in children).

Sponsors & Collaborators

• Luye Pharma Group Ltd.: lead

Study Sites (1)

The Sixth Hospital of Peking University

Beijing, China

Location

Related Publications (1)

• Mi W, Di X, Wang Y, Li H, Xu X, Li L, Wang H, Wang G, Zhang K, Tian F, Luo J, Yang C, Zhou Y, Xie S, Zhong H, Wu B, Yang D, Chen Z, Li Y, Chen J, Lv S, Yi Q, Jiang Z, Tian J, Zhang H. A phase 3, multicenter, double-blind, randomized, placebo-controlled clinical trial to verify the efficacy and safety of ansofaxine (LY03005) for major depressive disorder. Transl Psychiatry. 2023 May 10;13(1):163. doi: 10.1038/s41398-023-02435-0.

  PMID: 37164957 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Hongyan Zhang

  Peking University Sixth Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2021
• First Posted: April 21, 2021
• Study Start: December 5, 2018
• Primary Completion: December 24, 2020
• Study Completion: December 24, 2020
• Last Updated: November 15, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)