DepressionPhase 2NCT07018245

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

A Phase 2 study testing TJ0113 in people with Depression, run by Hangzhou PhecdaMed Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Depression
What is being tested?: TJ0113
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 149 participants
Where: 1 siteChina
Study dates: 9 Jul 2025to 2 Jul 2026
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subjects who voluntarily participates in the trial and signs the informed consent form (ICF);
Male or female subjects, aged between 18 and 65 years (inclusive) at the time of signing ICF;
Subjects whose HAMD-17 score ≥18 during the screening and baseline periods;
Subjects who meet the diagnostic criteria for depressive disorder as defined in the Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition) (DSM-5), without psychotic symptoms;
Subjects whose Clinical Global Impressions-Severity (CGI-S) scores ≥4 during the screening and baseline periods;
Subjects who agree to discontinue the use of other antidepressants, anxiolytics, antipsychotics, mood stabilizers, benzodiazepine sedative-hypnotics, etc., except those specified in the study protocol during the treatment period; Subjects with reproductive potential (including spouses of male subjects) must have no plans for pregnancy or sperm donation from the screening period until 6 months after the last dose and must be willing to use at least one effective contraceptive method (such as abstinence, condoms, etc., as detailed in Section 5.3).

Who cannot join

Presence of any medical condition that may interfere with the participation in the trial, including but not limited to the following: history of malignant tumors, history of epilepsy or complications, hemolytic anemia, pulmonary embolism, or respiratory depression;
Within 6 months prior to screening, occurrence of congestive heart failure classified as New York Heart Association (NYHA) Class III or higher, unstable angina, acute myocardial infarction, hemorrhagic stroke (stroke), or ischemic stroke (including transient ischemic attack); or undergoing percutaneous coronary intervention, coronary artery bypass grafting, cardiac valve repair/replacement; or presence of severe arrhythmia as determined by the investigator at screening;
A personal or family history of long QT syndrome, a family history of sudden death in first-degree relatives (parents, offspring, and siblings) before the age of 40; and/or a personal history of unexplained syncope within 1 year prior to screening; and/or QTcF >450 ms (male) or QTcF >470 ms (female) based on resting ECG results at screening;
Patients with uncontrolled hypertension at screening, defined as systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg (checked prior to randomization);
Subjects with clinically significant hepatic impairment, defined as total bilirubin (TBIL) >2× the upper limit of normal (ULN) or alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >2×ULN;
Subjects with clinically significant renal impairment (creatinine clearance [Ccr] <30 mL/min). The Ccr calculation formula is provided in Note b.

Show all 23Show fewer

Subjects with history of any psychiatric disorders other than DSM-5 depressive disorder, including but not limited to: bipolar and related disorders, obsessive-compulsive and related disorders, trauma- and stressor-related disorders, schizophrenia, anxiety disorders, sleep-wake disorders, substance-related and addictive disorders, or depressive episodes secondary to other psychiatric or somatic conditions;
Subjects whose HAMD-17 score at baseline shows a reduction ≥25% compared to the screening period.
Subjects at risk of suicide: Those who have exhibited suicidal behavior (including actual attempts, interrupted attempts, or failed attempts) within 1 year prior to the first dose, or subjects with a score ≥3 on item 3 (SUICIDE) of the HAMD-17 scale at screening or baseline, or a 'yes' response to items 4 or 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) for suicidal ideation, or subjects with a history of suicidal intent/self mutilation behavior during the current depressive episode;
Subjects with history or current episode of failure to respond to two adequate courses of antidepressant treatment;
Subjects who are receiving systemic psychotherapy (interpersonal therapy, psychodynamic therapy, cognitive behavioral therapy, etc.), music therapy, exercise therapy, acupuncture, or other treatments during screening and/or at baseline, and who will continue to require these treatments during this study period;
Subjects who have received electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), vagus nerve stimulation (VNS), deep brain stimulation (DBS), light therapy, etc., within 3 months prior to screening, or are considered by the investigator to currently require such treatment;
Subjects who discontinued psychotropic medications less than 5 half-lives before randomization (at least 2 weeks for monoamine oxidase inhibitors and at least 4 weeks for fluoxetine);
Subjects with history of severe allergies, or known hypersensitivity/allergic reaction or intolerance to any component of the investigational drug;
Subjects with evidence of alcohol abuse (average weekly consumption ≥14 units of alcohol, where 1 unit ≈ 360 mL of beer, 45 mL of spirits, or 150 mL of wine) or alcohol dependence within the 6 months prior to screening, which the investigator considers may interfere with the subject's understanding or completion of the trial;
Subjects with history of drug dependence/drug abuse within the past 1 year;
Subjects with history of hepatitis B, or positive hepatitis B virus surface antigen (HBsAg) at screening, or positive hepatitis C virus (HCV) antibody, or positive Human immunodeficiency virus (HIV) antibody, or positive treponema pallidum antibody;
Subjects who participated in a clinical trial involving the administration of investigational drugs (new chemical entities), devices, or surgical procedures within 3 months or 5 half-lives (whichever is longer) prior to screening;
Females with positive pregnancy test during screening or baseline visits, females who are pregnant, breastfeeding, or planning to become pregnant during the trial, or males or females of childbearing potential unwilling to use effective contraception within 6 months after the last dose;
Subjects who are unable to swallow medications, or as judged by the investigator, have any condition that may significantly affect drug absorption, distribution, metabolism, and excretion (such as active intestinal disease, partial or complete intestinal obstruction, chronic diarrhea, etc.), or any condition that may pose a hazard to the participating subjects;
Subjects with history of organ transplantation (excluding corneal transplantation);
Subjects who donated blood or experienced blood loss ≥400 mL, or received blood transfusion within 3 months prior to screening;
Subjects with poor compliance or other reasons that make the subject unsuitable for participation in this trial, as judged by the investigator.

Trial locations and contacts

1 site in 1 country.

China1 site

The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009

Other trials in China

About this study

Official title: A Phase II, Randomized, Double-Blind, Multi-Center, Placebo-Controlled, Parallel-GroupClinical Trial to Evaluate the Safety and Efficacy of TJ0113 Capsules in Patients withDepressive Disorder

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: Depression
Being tested: TJ0113, Placebo
Medical subject headings: Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TJ0113Drug
200 mg or 400 mg Capsule, Once Daily
PlaceboDrug
Capsule, Once Daily

Study groups in NCT07018245
Study group	Role	What they receive
TJ0113 200mg	Experimental	Subjects will receive 200 mg of TJ0113 capsules for 8 consecutive weeks Receives: Drug: TJ0113
TJ0113 400mg	Experimental	Subjects will receive 400 mg of TJ0113 capsules for 8 consecutive weeks Receives: Drug: TJ0113
Placebo	Placebo comparator	Subjects will receive 200mg or 400 mg of placebo for 8 consecutive weeks Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change from baseline in Hamilton Depression Rating Scale-17 Item Version (HAMD-17) score at 8 weeks post-treatment
The total score of the HAMD-17 ranges from 0 to 52, with higher scores indicating a more severe degree of depressive symptom.
Measured: After 8 weeks of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Jul 20252 Jul 2026

First posted12 Jun 2025
Study start9 Jul 2025
Primary completion25 Jun 2026
Study completion2 Jul 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for DepressionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 149 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07018245
Sponsor's protocol ID: TJJS01-101
Status last verified: Jun 2025
First submitted: 4 Jun 2025
Last updated: 25 Aug 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety

All Depression trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II, Randomized, Double-Blind, Multi-Center, Placebo-Controlled, Parallel-GroupClinical Trial to Evaluate the Safety and Efficacy of TJ0113 Capsules in Patients withDepressive Disorder
ClinicalTrials.gov ID: NCT07018245
Acronym / sponsor ID: TJJS01-101
Conditions: Depression
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 149 participants (actual)
Lead sponsor: Hangzhou PhecdaMed Co., Ltd.Industry (pharma, biotech, devices)
Study start: 9 Jul 2025 (actual)
Primary completion: 25 Jun 2026 (actual)
Study completion: 2 Jul 2026 (actual)
First posted: 12 Jun 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
TJ0113 200mg	Experimental	Drug: TJ0113Subjects will receive 200 mg of TJ0113 capsules for 8 consecutive weeks
TJ0113 400mg	Experimental	Drug: TJ0113Subjects will receive 400 mg of TJ0113 capsules for 8 consecutive weeks
Placebo	Placebo comparator	Drug: PlaceboSubjects will receive 200mg or 400 mg of placebo for 8 consecutive weeks

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Subjects who voluntarily participates in the trial and signs the informed consent form (ICF);
Male or female subjects, aged between 18 and 65 years (inclusive) at the time of signing ICF;
Subjects whose HAMD-17 score ≥18 during the screening and baseline periods;
Subjects who meet the diagnostic criteria for depressive disorder as defined in the Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition) (DSM-5), without psychotic symptoms;
Subjects whose Clinical Global Impressions-Severity (CGI-S) scores ≥4 during the screening and baseline periods;

Key exclusion criteria (23 listed)

Presence of any medical condition that may interfere with the participation in the trial, including but not limited to the following: history of malignant tumors, history of epilepsy or complications, hemolytic anemia, pulmonary embolism, or respiratory depression;
Within 6 months prior to screening, occurrence of congestive heart failure classified as New York Heart Association (NYHA) Class III or higher, unstable angina, acute myocardial infarction, hemorrhagic stroke (stroke), or ischemic stroke (including transient ischemic attack); or undergoing percutaneous coronary intervention, coronary artery bypass grafting, cardiac valve repair/replacement; or presence of severe arrhythmia as determined by the investigator at screening;
A personal or family history of long QT syndrome, a family history of sudden death in first-degree relatives (parents, offspring, and siblings) before the age of 40; and/or a personal history of unexplained syncope within 1 year prior to screening; and/or QTcF >450 ms (male) or QTcF >470 ms (female) based on resting ECG results at screening;
Patients with uncontrolled hypertension at screening, defined as systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg (checked prior to randomization);
Subjects with clinically significant hepatic impairment, defined as total bilirubin (TBIL) >2× the upper limit of normal (ULN) or alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >2×ULN;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TJ0113200 mg or 400 mg Capsule, Once Daily	Drug	TJ0113 200mg, TJ0113 400mg
PlaceboCapsule, Once Daily	Drug	Placebo

Primary outcome

Change from baseline in Hamilton Depression Rating Scale-17 Item Version (HAMD-17) score at 8 weeks post-treatment
Time frame: After 8 weeks of treatment
The total score of the HAMD-17 ranges from 0 to 52, with higher scores indicating a more severe degree of depressive symptom.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
Individual participant dataSharing planned: No

Related trials for Depression

Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Shaohua Hu principal investigator

First Affiliated Hospital of Zhejiang University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TJ0113 in people with Depression, run by Hangzhou PhecdaMed Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in Hamilton Depression Rating Scale-17 Item Version (HAMD-17) score at 8 weeks post-treatment (time frame: After 8 weeks of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07018245.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.