New depression pill faces off against leading drug in major trial

NCT ID NCT07253207

Symptom relief Sponsor: Zhejiang Huahai Pharmaceutical Co., Ltd. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new drug, levomilnacipran, for treating major depression. It involved 392 adults aged 18 to 65 with moderate to severe depression. The drug was compared to duloxetine, a commonly used antidepressant, over 8 weeks to see how well it eased symptoms and if it was safe.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

392 people

The number who actually took part.

Started

Oct 2024

Finished

Jul 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Outpatient patients aged 18 to 65 years (inclusive of 18 but exclusive of 65), regardless of gender; 2. Meet the diagnostic criteria for depression as per the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), with a duration of at least 3 months for first-episode cases (30 days per month); 3. Current depressive episode confirmed using the Mini-International Neuropsychiatric Interview (M.I.N.I.) version 7.0.0 or higher; 4. Total HAMD17 score ≥18 at screening and baseline visits; 5. CGI-S score ≥4 at screening and baseline visits; 6. Agree to use effective contraception during the trial and for 30 days after the last dose (women of childbearing potential must have a negative pregnancy test before dosing and not be breastfeeding), and men and women must have no plans to donate sperm or eggs, respectively; 7. Voluntarily participate in the trial and sign the informed consent form. Exclusion Criteria: 1. Meet DSM-5 diagnostic criteria for other mental disorders (including but not limited to schizophrenia spectrum and other psychotic disorders, bipolar and related disorders, obsessive-compulsive and related disorders, somatic symptom and related disorders); 2. Previous failure to respond to adequate dose and duration (maximum recommended dose for MDD as per label for at least 4 weeks) of serotonin and norepinephrine reuptake inhibitors (including but not limited to milnacipran, levomilnacipran, duloxetine, venlafaxine, desvenlafaxine), or failure to respond to adequate dose and duration of at least two antidepressant drugs; 3. Allergic to milnacipran, levomilnacipran, duloxetine, or excipients of the trial drug, or have an allergic constitution; 4. History of suicide attempt within 1 year prior to screening; suicidal or self-harming behavior during screening; HAMD17 item 3 (suicide) score ≥3; currently at high suicide risk; 5. Depression secondary to other diseases; 6. History of epileptic seizures (except for febrile convulsions in childhood); 7. Received systematic electroconvulsive therapy, transcranial magnetic stimulation, transcranial direct current stimulation, systematic psychotherapy, or other treatments with antidepressant effects within 3 months prior to screening; received electroconvulsive therapy within 1 month prior to screening; 8. Discontinuation of psychotropic drugs or their active metabolites less than 5 half-lives, or monoamine oxidase inhibitors less than 2 weeks, before randomization; 9. Required to use drugs with clinically significant interactions with the trial drug during the trial (including but not limited to monoamine oxidase inhibitors, other serotonergic drugs, drugs affecting coagulation, strong CYP3A4/CYP1A2/CYP2D6 inhibitors or inducers, alcohol, linezolid, and intravenous methylene blue); 10. Conditions affecting drug swallowing or absorption, as judged by the investigator; 11. Risk factors for angle-closure glaucoma, as judged by the investigator; 12. Abnormal and clinically significant results from physical examinations or laboratory tests at screening or baseline, as judged by the investigator, including but not limited to ALT, AST, total bilirubin, or serum creatinine \>1.5 times the upper limit of normal, or thyroid-stimulating hormone outside the normal range; 13. Current or past medical history of diseases or dysfunctions affecting the trial, as judged by the investigator, including but not limited to chronic or acute diseases of the nervous, motor, circulatory, respiratory, digestive, urinary, endocrine, reproductive, or immune systems; 14. Clinically significant cardiovascular diseases, as judged by the investigator, including but not limited to atrial fibrillation, second- or third-degree atrioventricular block, myocardial infarction within 12 months, or NYHA heart function class III or above; 15. ECG QTcF interval ≥450 ms (males) or ≥470 ms (females), or other factors increasing the risk of QTcF prolongation or arrhythmic events (including but not limited to heart failure, hypokalemia, family history of long QT syndrome), or ECG heart rate \<50 bpm or \>120 bpm (Note: QTcF = QT/(RR\^0.33)); 16. Resting seated systolic blood pressure \<90 mmHg or \>140 mmHg, or diastolic blood pressure \<50 mmHg or \>90 mmHg; 17. Diagnosed with end-stage renal disease at screening or previously, as judged by the investigator; 18. History of malignant tumors, as judged by the investigator at screening or previously; 19. Positive virological screening for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCVAb), syphilis antibody, or human immunodeficiency virus (HIV) antibody during screening; 20. History of drug or alcohol abuse; 21. Weekly alcohol consumption exceeding 14 units in the 6 months prior to screening (1 unit = 360 mL beer, 45 mL 40% liquor, or 150 mL wine); 22. Inability to comply with medication instructions, as judged by the investigator; 23. Physiological or psychological conditions that may increase trial risks, affect protocol compliance, or prevent trial completion, as judged by the investigator; 24. Participation in any clinical trial (received investigational drugs or medical devices) within 30 days before signing the informed consent form; 25. Concomitant diseases that may interfere with trial procedures or assessments, or other conditions deemed unsuitable for trial participation by the investigator.

Get updates

Get notified about this study

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

major depressive disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Major depressive disorder (MDD)

Contacts and locations

Locations

Affiliated Brain Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510370, China
Beijing Anding Hospital Capital Medical University

Beijing, Beijing Municipality, 100000, China
Beijing HuiLongGuan Hospital

Beijing, Beijing Municipality, 102200, China
Chengdu Fourth People's Hospital

Chengdu, Sichuan, 610041, China
Chongqing Mental Health Center

Chongqing, Chongqing Municipality, 401147, China
Hangzhou Seventh People's Hospital

Hangzhou, Zhejiang, 310007, China
Hebei Provincial Mental Health Center

Baoding, Hebei, 071030, China
Hefei Fourth People's Hospital

Hefei, Anhui, 230031, China
Hunan Provincial Second People's Hospital

Changsha, Hunan, 410007, China
Huzhou Third People's Hospital

Huzhou, Zhejiang, 313000, China
Jiangxi Provincial Psychiatric Hospital

Nanchang, Jiangxi, 330029, China
Jilin Provincial Neuropsychiatric Hospital

Siping, Jilin, 136000, China
Linfen Central Hospital

Linfen, Shanxi, 041099, China
Nantong Mental Health Center

Nantong, Jiangsu, 226005, China
Ningbo University Affiliated Kangning Hospital

Ningbo, Zhejiang, 315201, China
Shandong Provincial Mental Health Center

Jinan, Shandong, 250014, China
Shanghai Pudong New Area Mental Health Center

Shanghai, Shanghai Municipality, 200124, China
Suzhou Guangji Hospital

Suzhou, Jiangsu, 215131, China
The First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, 650032, China
The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330006, China
The First Affiliated Hospital of Xi 'an Jiaotong University

Xi'an, Shaanxi, 710061, China
The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China
The First Hospital of Shanxi Medical University

Taiyuan, Shanxi, 030001, China
Tianjin Fourth Central Hospital

Tianjin, Tianjin Municipality, 300074, China
Wuhu Hospital of Beijing Anding Hospital, Capital Medical University

Wuhu, Anhui, 241003, China
Wuxi Mental Health Center

Wuxi, Jiangsu, 214000, China
Xi 'an Mental Health Center

Xi'an, Shaanxi, 710199, China
Zhenjiang Mental Health Center

Zhenjiang, Jiangsu, 212021, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.