Major Depressive Disorder (MDD)Phase 3NCT04853407
A Study to Evaluate the Efficacy and Safety of Ansofaxine Hydrochloride Extended-release Tablets in the Treatment of Major Depressive Disorder (MDD)
A Phase 3 study testing LY03005 extended-release tablet in people with Major Depressive Disorder (MDD), run by Luye Pharma Group Ltd. at 1 site in China.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder (MDD)
- What is being tested?
- LY03005 extended-release tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 558 participants
- Where
- 1 siteChina
- Study dates
- 5 Dec 2018to 24 Dec 2020
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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
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)
Read the 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.
- Conditions
- Major Depressive Disorder (MDD)
- Being tested
- LY03005 extended-release tablet, Placebo
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY03005 extended-release tabletDrug
orally once a day
PlaceboDrug
orally once a day
| Study group | Role | What they receive |
|---|---|---|
| LY03005 extended-release tablets 80 mg group | Experimental | orally once a day Receives: Drug: LY03005 extended-release tablet |
| LY03005 extended-release tablets 160 mg group | Experimental | orally once a day Receives: Drug: LY03005 extended-release tablet |
| Placebo group | Placebo comparator | orally once a day Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 8 Weeks
Secondary outcomes (1)
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.
Measured: 8 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2021
- Study start5 Dec 2018
- Primary completion24 Dec 2020
- Study completion24 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major Depressive Disorder (MDD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 558 participants (actual)
Sponsor and investigators
- Lead sponsor
- Luye Pharma Group Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hongyan Zhang, Principal investigator, Peking University Sixth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04853407
- Sponsor's protocol ID
- LY03005/CT-CHN-305
- Status last verified
- Nov 2021
- First submitted
- 8 Apr 2021
- Last updated
- 15 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37164957