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Clinical Trial of TJ0113 Capsules in the Treatment of Patients With Depressive Disorder

NCT07018245 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-01-28

No results posted yet for this study

Summary

This study is a phase II, randomized, double-blind, multi-center, placebo-controlled, parallel-group clinical trial and 150 subjects with depressive disorder will be enrolled. Subjects will be randomly assigned in a 1:1 ratio to two cohorts (Cohort 1: 200 mg dose group; Cohort 2: 400 mg dose group). Within each cohort, subjects will be randomized in a 2:1 ratio to either the TJ0113 capsule group or the placebo group, with approximately 50 subjects receiving TJ0113 capsules and approximately 25 receiving placebo. Approximately 50 subjects will be enrolled in each of the TJ0113 capsule 200 mg group, TJ0113 capsule 400 mg group, and placebo group in this trial. Eligible subjects will be randomly assigned to receive continuous oral administration for 8 weeks, after which efficacy and safety will be evaluated, followed by an additional 1-week follow-up period after the end of treatment.

Conditions

Interventions

DRUG

TJ0113

200 mg or 400 mg Capsule, Once Daily

DRUG

Placebo

Capsule, Once Daily

Sponsors & Collaborators

  • Hangzhou PhecdaMed Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Shaohua Hu · Zhejiang University

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
2025-07-09
Primary Completion
2026-05-25
Completion
2026-09-01

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

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 NCT07018245 on ClinicalTrials.gov