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

Luye Pharma Group Ltd.0 sites736 target enrollmentMay 30, 2024

ConditionsMajor Depressive Disorder

InterventionsToludesvenlafaxine Hydrochloride Sustained-release Tablets placebo

DrugsToludesvenlafaxine Hydrochloride Sustained-release Tablets placebo

Overview

Phase: Phase 4
Intervention: Toludesvenlafaxine Hydrochloride Sustained-release Tablets
Conditions: Major Depressive Disorder
Sponsor: Luye Pharma Group Ltd.
Enrollment: 736
Primary Endpoint: Time to relapse.
Status: Not yet recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

May 30, 2024

End Date

June 30, 2027

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Luye Pharma Group Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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;
•Aged 18 years and above, male or female;
•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);
•MADRS total score ≥ 26 at baseline of screening and open treatment phase.

Exclusion Criteria

•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);
•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;
•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");
•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;
•Previous history of increased intraocular pressure or closed glaucoma;
•Patients with poorly controlled hypertension \[screening or baseline sitting systolic blood pressure (SBP) ≥ 160 mmHg or sitting diastolic blood pressure (DBP) ≥ 100 mmHg\];
•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;
•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;
•Patients who received electroconvulsive therapy (ECT) within 3 months before screening or currently require ECT according to the investigator's judgment;
•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;

Arms & Interventions

Toludesvenlafaxine Hydrochloride Sustained-release Tablets 80 mg or 160 mg group

orally once a day

Intervention: Toludesvenlafaxine Hydrochloride Sustained-release Tablets

Placebo

orally once a day

Intervention: placebo

Outcomes

Primary Outcomes

Time to relapse.

Time Frame: from Baseline to week 24

Secondary Outcomes

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])
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 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)