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

NCT ID: NCT04853407

Last Updated: 2021-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

558 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-05

Study Completion Date

2020-12-24

Brief Summary

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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)

Detailed Description

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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.

Conditions

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Major Depressive Disorder (MDD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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LY03005 extended-release tablets 80 mg group

orally once a day

Group Type EXPERIMENTAL

LY03005 extended-release tablet

Intervention Type DRUG

orally once a day

LY03005 extended-release tablets 160 mg group

orally once a day

Group Type EXPERIMENTAL

LY03005 extended-release tablet

Intervention Type DRUG

orally once a day

Placebo group

orally once a day

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

orally once a day

Interventions

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LY03005 extended-release tablet

orally once a day

Intervention Type DRUG

Placebo

orally once a day

Intervention Type DRUG

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Luye Pharma Group Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hongyan Zhang

Role: PRINCIPAL_INVESTIGATOR

Peking University Sixth Hospital

Locations

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The Sixth Hospital of Peking University

Beijing, , China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 37164957 (View on PubMed)

Other Identifiers

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LY03005/CT-CHN-305

Identifier Type: -

Identifier Source: org_study_id