Actively Recruiting
Clinical Trial of TJ0113 Capsules in the Treatment of Patients With Depressive Disorder
Led by Hangzhou PhecdaMed Co., Ltd. · Updated on 2026-01-28
150
Participants Needed
1
Research Sites
59 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Clinical Trial of TJ0113 Capsules in the Treatment of Patients With Depressive Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects who voluntarily participate in the trial and sign the informed consent form
- Male or female subjects aged between 18 and 65 years inclusive
- Subjects with a Hamilton Depression Rating Scale-17 (HAMD-17) score of 18 or higher during screening and baseline
- Subjects meeting DSM-5 criteria for depressive disorder without psychotic symptoms
- Subjects with Clinical Global Impressions-Severity (CGI-S) scores of 4 or higher during screening and baseline
- Subjects agreeing to stop other antidepressants, anxiolytics, antipsychotics, mood stabilizers, and benzodiazepine sedative-hypnotics during treatment except those allowed in the protocol
- Subjects with reproductive potential who agree to use effective contraception from screening until 6 months after last dose
You will not qualify if you...
- Presence of medical conditions interfering with trial participation, including history of malignant tumors, epilepsy, hemolytic anemia, pulmonary embolism, or respiratory depression
- History of severe heart issues within 6 months before screening such as congestive heart failure NYHA Class III or higher, unstable angina, acute myocardial infarction, hemorrhagic or ischemic stroke, or recent cardiac surgeries
- Personal or family history of long QT syndrome, sudden death in first-degree relatives before age 40, unexplained syncope within 1 year, or prolonged QTcF on ECG
- Uncontrolled hypertension defined as systolic 60 mmHg or diastolic 100 mmHg prior to randomization
- Clinically significant liver impairment with elevated bilirubin or liver enzymes
- Clinically significant kidney impairment with creatinine clearance below 30 mL/min
- History of psychiatric disorders other than depressive disorder, including bipolar disorder, OCD, schizophrenia, anxiety disorders, substance abuse, or secondary depressive episodes
- Reduction of 25% or more in HAMD-17 score from screening to baseline
- Suicide risk including recent suicidal behavior, high suicide ideation scores, or history of self-harm during current episode
- History of non-response to two adequate antidepressant treatments
- Ongoing systemic psychotherapy, music, exercise, acupuncture, or similar therapies requiring continuation during study
- Receipt of ECT, TMS, VNS, DBS, or light therapy within 3 months before screening or current need for such treatments
- Discontinuation of psychotropic medications less than 5 half-lives before randomization
- History of severe allergies or known intolerance to study drug components
- Evidence of alcohol abuse or dependence within 6 months prior to screening
- History of drug dependence or abuse within 1 year
- History or positive tests for hepatitis B, hepatitis C, HIV, or syphilis
- Participation in other clinical trials involving investigational drugs or devices within 3 months or 5 half-lives prior to screening
- Positive pregnancy test or pregnancy, breastfeeding, or unwillingness to use contraception
- Inability to swallow medications or conditions affecting drug absorption or metabolism
- History of organ transplantation excluding corneal
- Blood donation or loss of 400 mL or more, or blood transfusion within 3 months prior to screening
- Poor compliance or other factors making participation unsuitable as judged by investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310009
Actively Recruiting
Research Team
D
Dong Liu
CONTACT
Y
Yasu Zhang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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