Efficacy and Safety Study of Levomilnacipran Hydrochloride Extended-Release Capsules in Major Depressive Disorder
NCT ID: NCT07253207
Last Updated: 2025-11-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
392 participants
INTERVENTIONAL
2024-10-17
2025-07-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Duloxetine Hydrochloride Enteric Capsules
Duloxetine Hydrochloride Enteric Capsules
Treatment period: Duloxetine Hydrochloride Enteric Capsules 60mg/day is to be given orally, once daily, for 8 weeks.
Reduction period: Duloxetine Hydrochloride Enteric Capsules 60mg/day is to be given orally, once daily, for 2 weeks.
Levomilnacipran Hydrochloride Extended-Release Capsules
Levomilnacipran Hydrochloride Extended-Release Capsules
Treatment period:
1. Levomilnacipran Hydrochloride Extended-Release Capsules 20mg/day is to be given orally, once daily, for 1-2 days in the first week of treatment.
2. Levomilnacipran Hydrochloride Extended-Release Capsules 40mg/day is to be given orally, once daily, for 3-7 days in the first week of treatment.
3. Levomilnacipran Hydrochloride Extended-Release Capsules 80mg/day is to be given orally, once daily, for the second week of treatment.
4. Levomilnacipran Hydrochloride Extended-Release Capsules 40, 80 or 120mg/day (the dosage based on the participant's clinical response and tolerance) is to be given orally, once daily, for the weeks 3 to 8 of treatment.
Reduction period: Dosage of 20-80mg/day based on the tolerable dose during the 8th week of treatment.
Interventions
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Levomilnacipran Hydrochloride Extended-Release Capsules
Treatment period:
1. Levomilnacipran Hydrochloride Extended-Release Capsules 20mg/day is to be given orally, once daily, for 1-2 days in the first week of treatment.
2. Levomilnacipran Hydrochloride Extended-Release Capsules 40mg/day is to be given orally, once daily, for 3-7 days in the first week of treatment.
3. Levomilnacipran Hydrochloride Extended-Release Capsules 80mg/day is to be given orally, once daily, for the second week of treatment.
4. Levomilnacipran Hydrochloride Extended-Release Capsules 40, 80 or 120mg/day (the dosage based on the participant's clinical response and tolerance) is to be given orally, once daily, for the weeks 3 to 8 of treatment.
Reduction period: Dosage of 20-80mg/day based on the tolerable dose during the 8th week of treatment.
Duloxetine Hydrochloride Enteric Capsules
Treatment period: Duloxetine Hydrochloride Enteric Capsules 60mg/day is to be given orally, once daily, for 8 weeks.
Reduction period: Duloxetine Hydrochloride Enteric Capsules 60mg/day is to be given orally, once daily, for 2 weeks.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
65 Years
ALL
No
Sponsors
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Zhejiang Huahai Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Hefei Fourth People's Hospital
Hefei, Anhui, China
Wuhu Hospital of Beijing Anding Hospital, Capital Medical University
Wuhu, Anhui, China
Beijing Anding Hospital Capital Medical University
Beijing, Beijing Municipality, China
Beijing HuiLongGuan Hospital
Beijing, Beijing Municipality, China
Chongqing Mental Health Center
Chongqing, Chongqing Municipality, China
Affiliated Brain Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Hebei Provincial Mental Health Center
Baoding, Hebei, China
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Hunan Provincial Second People's Hospital
Changsha, Hunan, China
Nantong Mental Health Center
Nantong, Jiangsu, China
Suzhou Guangji Hospital
Suzhou, Jiangsu, China
Wuxi Mental Health Center
Wuxi, Jiangsu, China
Zhenjiang Mental Health Center
Zhenjiang, Jiangsu, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Jiangxi Provincial Psychiatric Hospital
Nanchang, Jiangxi, China
Jilin Provincial Neuropsychiatric Hospital
Siping, Jilin, China
The First Affiliated Hospital of Xi 'an Jiaotong University
Xi'an, Shaanxi, China
Xi 'an Mental Health Center
Xi'an, Shaanxi, China
Shandong Provincial Mental Health Center
Jinan, Shandong, China
Shanghai Pudong New Area Mental Health Center
Shanghai, Shanghai Municipality, China
Linfen Central Hospital
Linfen, Shanxi, China
The First Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
Chengdu Fourth People's Hospital
Chengdu, Sichuan, China
Tianjin Fourth Central Hospital
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
Hangzhou Seventh People's Hospital
Hangzhou, Zhejiang, China
Huzhou Third People's Hospital
Huzhou, Zhejiang, China
Ningbo University Affiliated Kangning Hospital
Ningbo, Zhejiang, China
Countries
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Other Identifiers
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HH-ZMNPL-2024
Identifier Type: -
Identifier Source: org_study_id
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