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

Luye Pharma Group

Status and phase: Completed; Phase 3

Conditions: Major Depressive Disorder (MDD)

Treatments: Drug: Placebo; Drug: LY03005 extended-release tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT04853407

LY03005/CT-CHN-305

Details and patient eligibility

About

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)

Full 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.

Enrollment: 558 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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558 participants in 3 patient groups, including a placebo group

LY03005 extended-release tablets 80 mg group

Experimental group

Description:

orally once a day

Treatment:

Drug: LY03005 extended-release tablet

LY03005 extended-release tablets 160 mg group

Experimental group

Description:

orally once a day

Treatment:

Drug: LY03005 extended-release tablet

Placebo group

Placebo Comparator group

Description:

orally once a day

Treatment:

Drug: Placebo