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Compare the Efficacy and Safety of KH607 Tablets Versus Vortioxetine Hydrobromide Tablets in Adult Patients With Major Depressive Disorder

NCT07741331 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 326

Last updated 2026-08-03

No results posted yet for this study

Summary

This trial includes a short-term study and a long-term study. The short-term study is a multicenter, randomized, double-Blind, double-Dummy, Parallel-Controlled study with a 6-week duration. The long-term study is a withdrawal follow-up study; participants meeting relapse criteria may receive one cycle of KH607 Tablets treatment.

Conditions

  • Major Depressive Disorder (MDD)

Interventions

DRUG

KH607 tablets

oral 20mg, once daily for 21 days.

DRUG

Vortioxetine Hydrobromide Tablets

oral 10mg, once daily for 42 days.

DRUG

Part B: KH607

oral 20mg, once daily for 21 days.

Sponsors & Collaborators

  • Chengdu Kanghong Pharmaceutical Group Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2027-12-31
Completion
2028-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07741331 on ClinicalTrials.gov