Back to resultsA Study to Evaluate the Efficacy and Safety of Ansofaxine Hydrochloride Extended-release Tablets in the Treatment of Major Depressive Disorder (MDD)
Primary Purpose
Major Depressive Disorder (MDD)
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
LY03005 extended-release tablet
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder (MDD)
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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).
Sites / Locations
- The Sixth Hospital of Peking University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
LY03005 extended-release tablets 80 mg group
LY03005 extended-release tablets 160 mg group
Placebo group
Arm Description
orally once a day
orally once a day
orally once a day
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT04853407
First Posted
April 8, 2021
Last Updated
November 11, 2021
Sponsor
Luye Pharma Group Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04853407
Brief Title
A Study to Evaluate the Efficacy and Safety of Ansofaxine Hydrochloride Extended-release Tablets in the Treatment of Major Depressive Disorder (MDD)
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
December 5, 2018 (Actual)
Primary Completion Date
December 24, 2020 (Actual)
Study Completion Date
December 24, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Luye Pharma Group Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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)
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder (MDD)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
558 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LY03005 extended-release tablets 80 mg group
Arm Type
Experimental
Arm Description
orally once a day
Arm Title
LY03005 extended-release tablets 160 mg group
Arm Type
Experimental
Arm Description
orally once a day
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
orally once a day
Intervention Type
Drug
Intervention Name(s)
LY03005 extended-release tablet
Intervention Description
orally once a day
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
orally once a day
Primary Outcome Measure Information:
Title
Montgomery- Åsberg Depression Rating Scale(MADRS)
Description
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).
Time Frame
8 Weeks
Secondary Outcome Measure Information:
Title
17 items Hamilton Depression Scales (HAM-D17)
Description
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.
Time Frame
8 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hongyan Zhang
Organizational Affiliation
Peking University Sixth Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Sixth Hospital of Peking University
City
Beijing
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study to Evaluate the Efficacy and Safety of Ansofaxine Hydrochloride Extended-release Tablets in the Treatment of Major Depressive Disorder (MDD)
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