To Evaluate the Long-term Efficacy and Safety of Toludevenlafaxine Hydrochloride Sustained-release Tablets

A Multicenter, Randomized Withdrawal, Double-blind, Parallel, Placebo-controlled Design Clinical Trial of Toludesvenlafaxine Hydrochloride Extended-Release Tablets

This is a multicenter, randomized withdrawal, double-blind, parallel, placebo-controlled design clinical trial of Toludesvenlafaxine Hydrochloride Extended-Release Tablets to evaluate the long-term efficacy and safety in the treatment of Chinese patients with depression.

Study Overview

• Status: Not yet recruiting
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Drug: placebo; Drug: Toludesvenlafaxine Hydrochloride Sustained-release Tablets

• Study Type: Interventional
• Enrollment (Estimated): 736
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Hongyan Zhang; Phone Number: 13601237138; Email: hongyanzhang@bjmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. The subject voluntarily signs the informed consent form and is able to comply with the scheduled visits, treatment plan, laboratory tests and other study procedures;
2. Aged 18 years and above, male or female;
3. Outpatients with the main diagnosis of depression meeting DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, 5th Edition) diagnostic criteria for recurrent episodes (without psychotic features) (F33.1/F33.2);
4. MADRS total score ≥ 26 at baseline of screening and open treatment phase.

Exclusion Criteria:

1. Patients who meet the criteria of treatment-resistant depression, that is, patients who have failed to respond to at least two antidepressants with different mechanisms of action in the case of adequate treatment (at least 8 weeks of treatment at the maximum recommended therapeutic dose);
2. Known to have a history of allergy to any component of the investigational product or similar drugs, or allergic constitution (allergic to two or more drugs or food) and the investigator considers it inappropriate to participate in the trial;
3. Significant suicide attempt (defined as a score of ≥ 4 on item 10 of the MADRS scale) or suicidal behavior in the past 6 months on the Columbia-Suicide Severity Rating Scale (C-SSRS) ("actual attempt","interrupted attempt", and"abandoned attempt"with any outcome of"yes");
4. Other diseases meeting DSM-5 diagnostic criteria, including organic mental disorders, substance-related and addictive disorders (except nicotine or caffeine), schizophrenia spectrum and other psychotic disorders, bipolar and related disorders, substance/drug-induced depressive disorders, depressive disorders due to other physical/mental diseases, obsessive-compulsive and related disorders, traumatic and stress-related disorders, dissociative disorders, anorexia nervosa or bulimia, personality disorders;
5. Previous history of increased intraocular pressure or closed glaucoma;
6. Patients with poorly controlled hypertension [screening or baseline sitting systolic blood pressure (SBP) ≥ 160 mmHg or sitting diastolic blood pressure (DBP) ≥ 100 mmHg];
7. Total bilirubin (TBIL) value 1.5 times higher than the upper limit of normal, or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) 3 times higher than the upper limit of normal, or creatinine 1.5 times higher than the upper limit of normal at screening;
8. Female patients who are pregnant or have a positive pregnancy test result, or male and female subjects of childbearing potential do not agree to use effective contraception throughout the study and for at least 1 month after discontinuation;
9. Patients who received electroconvulsive therapy (ECT) within 3 months before screening or currently require ECT according to the investigator's judgment;
10. Patients who have received or are receiving systemic psychotherapy (interpersonal therapy, dynamic therapy, cognitive behavioral therapy) within 3 months before screening or currently need systemic psychotherapy according to the investigator's judgment;
11. Patients who received physical therapy such as transcranial magnetic stimulation (TMS), deep brain stimulation, vagus nerve stimulation and transcranial electrical stimulation within 3 months before screening;
12. Patients who received phototherapy within 2 weeks before screening;
13. Patients who have stopped antidepressant drugs for less than 5 half-lives (at least 2 weeks for monoamine oxidase inhibitors (MAOIs) and 1 month for fluoxetine) before enrollment;
14. Those who have participated in other clinical trials within 1 month before screening (excluding those who are not eligible after screening and not enrolled);
15. Currently suffering from acute or severe unstable physical illness, or other conditions that the investigator judges the subject is not suitable for the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Toludesvenlafaxine Hydrochloride Sustained-release Tablets 80 mg or 160 mg group; orally once a day	Drug: Toludesvenlafaxine Hydrochloride Sustained-release Tablets; orally once a day
Placebo Comparator: Placebo; orally once a day	Drug: placebo; orally once a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time to relapse.	from Baseline to week 24

Secondary Outcome Measures

Outcome Measure	Time Frame
Change From Double-Blind Treatment Period Baseline in Montgomery - Eisberg Depression Rating Scale (MADRS) Total Score;	from Baseline to week 24
Change from Double-Blind Treatment Period Baseline in Clinical Global Impression Scale - Severity of Illness (CGI-S) score and Clinical Global Impression Scale - Global Improvement (CGI-I) score	from Baseline to week 24
Change From Double-Blind Treatment Period Baseline in Hamilton Anxiety Rating Scale (HAMA) Total Score.	from Baseline to week 24
Change From Double-Blind Treatment Period Baseline in the Anhedonia Rating Scale (DARS) Score	from Baseline to week 24
Change From Double-Blind Treatment Period Baseline in SHEEHAN Disability Scale (SDS) Score	from Baseline to week 24
Change from Double-Blind Treatment Period Baseline in Digit Symbol Substitution Test (DSST) Score	from Baseline to week 24]

Collaborators and Investigators

• Sponsor: Luye Pharma Group Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): May 30, 2024
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: April 24, 2024
• First Submitted That Met QC Criteria: May 17, 2024
• First Posted (Actual): May 23, 2024

Study Record Updates

• Last Update Posted (Actual): May 23, 2024
• Last Update Submitted That Met QC Criteria: May 17, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: LY03005/CT-CHN-408

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No