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Major Depressive Disorder (MDD)Phase 3NCT07253207

Efficacy and Safety Study of Levomilnacipran Hydrochloride Extended-Release Capsules in Major Depressive Disorder

A Phase 3 study testing Levomilnacipran Hydrochloride Extended-Release Capsules and Duloxetine Hydrochloride Enteric Capsules in people with Major Depressive Disorder (MDD), run by Zhejiang Huahai Pharmaceutical Co., Ltd. at 28 sites in China.

Completed

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

Official record
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Trial summary

The purpose of this study is using Duloxetine Hydrochloride Enteric Capsules as the positive control, to evaluate the efficacy and safety of Levomilnacipran Hydrochloride Extended-Release Capsules in patients with Major Depressive Disorder (MDD). Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Major Depressive Disorder (MDD)
What is being tested?
Levomilnacipran Hydrochloride Extended-Release Capsules and Duloxetine Hydrochloride Enteric Capsules
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
392 participants
Where
28 sitesChina
Study dates
17 Oct 2024to 22 Jul 2025
Phase
Phase 3
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

  • Outpatient patients aged 18 to 65 years (inclusive of 18 but exclusive of 65), regardless of gender;
  • 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);
  • Current depressive episode confirmed using the Mini-International Neuropsychiatric Interview (M.I.N.I.) version 7.0.0 or higher;
  • Total HAMD17 score ≥18 at screening and baseline visits;
  • CGI-S score ≥4 at screening and baseline visits;
  • 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;
  • Voluntarily participate in the trial and sign the informed consent form.

Who cannot join

  • 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);
  • 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;
  • Allergic to milnacipran, levomilnacipran, duloxetine, or excipients of the trial drug, or have an allergic constitution;
  • 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;
  • Depression secondary to other diseases;
  • History of epileptic seizures (except for febrile convulsions in childhood);
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  • 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;
  • Discontinuation of psychotropic drugs or their active metabolites less than 5 half-lives, or monoamine oxidase inhibitors less than 2 weeks, before randomization;
  • 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);
  • Conditions affecting drug swallowing or absorption, as judged by the investigator;
  • Risk factors for angle-closure glaucoma, as judged by the investigator;
  • 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;
  • 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;
  • 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;
  • 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));
  • Resting seated systolic blood pressure <90 mmHg or >140 mmHg, or diastolic blood pressure <50 mmHg or >90 mmHg;
  • Diagnosed with end-stage renal disease at screening or previously, as judged by the investigator;
  • History of malignant tumors, as judged by the investigator at screening or previously;
  • Positive virological screening for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCVAb), syphilis antibody, or human immunodeficiency virus (HIV) antibody during screening;
  • History of drug or alcohol abuse;
  • 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);
  • Inability to comply with medication instructions, as judged by the investigator;
  • Physiological or psychological conditions that may increase trial risks, affect protocol compliance, or prevent trial completion, as judged by the investigator;
  • Participation in any clinical trial (received investigational drugs or medical devices) within 30 days before signing the informed consent form;
  • Concomitant diseases that may interfere with trial procedures or assessments, or other conditions deemed unsuitable for trial participation by the investigator.

Trial locations and contacts

28 sites in 1 country.

28 sites in 1 country

China28 sites

  • Hebei Provincial Mental Health Center

    Baoding, Hebei, 071030

  • Beijing Anding Hospital Capital Medical University

    Beijing, Beijing Municipality, 100000

  • Beijing HuiLongGuan Hospital

    Beijing, Beijing Municipality, 102200

  • Hunan Provincial Second People's Hospital

    Changsha, Hunan, 410007

  • Chengdu Fourth People's Hospital

    Chengdu, Sichuan, 610041

  • Chongqing Mental Health Center

    Chongqing, Chongqing Municipality, 401147

  • Affiliated Brain Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510370

  • Hangzhou Seventh People's Hospital

    Hangzhou, Zhejiang, 310007

  • Hefei Fourth People's Hospital

    Hefei, Anhui, 230031

  • Huzhou Third People's Hospital

    Huzhou, Zhejiang, 313000

  • Shandong Provincial Mental Health Center

    Jinan, Shandong, 250014

  • The First Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan, 650032

  • Linfen Central Hospital

    Linfen, Shanxi, 041099

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

  • Jiangxi Provincial Psychiatric Hospital

    Nanchang, Jiangxi, 330029

  • Nantong Mental Health Center

    Nantong, Jiangsu, 226005

  • Ningbo University Affiliated Kangning Hospital

    Ningbo, Zhejiang, 315201

  • Shanghai Pudong New Area Mental Health Center

    Shanghai, Shanghai Municipality, 200124

  • The First Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050000

  • Jilin Provincial Neuropsychiatric Hospital

    Siping, Jilin, 136000

  • Suzhou Guangji Hospital

    Suzhou, Jiangsu, 215131

  • The First Hospital of Shanxi Medical University

    Taiyuan, Shanxi, 030001

  • Tianjin Fourth Central Hospital

    Tianjin, Tianjin Municipality, 300074

  • Wuhu Hospital of Beijing Anding Hospital, Capital Medical University

    Wuhu, Anhui, 241003

  • Wuxi Mental Health Center

    Wuxi, Jiangsu, 214000

  • The First Affiliated Hospital of Xi 'an Jiaotong University

    Xi'an, Shaanxi, 710061

  • Xi 'an Mental Health Center

    Xi'an, Shaanxi, 710199

  • Zhenjiang Mental Health Center

    Zhenjiang, Jiangsu, 212021

Other trials in China

About this study

Official title: A Randomized, Double-Blind, Active-Controlled, Multicenter Phase III Clinical Trial Evaluating the Efficacy and Safety of Levomilnacipran Hydrochloride Extended-Release Capsules in the Treatment of Patients With Major Depressive Disorder (MDD)

The purpose of this study is using Duloxetine Hydrochloride Enteric Capsules as the positive control, to evaluate the efficacy and safety of Levomilnacipran Hydrochloride Extended-Release Capsules in patients with Major Depressive Disorder (MDD).

Being tested
Levomilnacipran Hydrochloride Extended-Release Capsules, Duloxetine Hydrochloride Enteric Capsules
Medical subject headings
Depressive Disorder, Major

What participants receive

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

  • Levomilnacipran Hydrochloride Extended-Release CapsulesDrug

    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 CapsulesDrug

    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.

Study groups in NCT07253207
Study groupRoleWhat they receive
Duloxetine Hydrochloride Enteric CapsulesActive comparatorNot described
Receives: Drug: Duloxetine Hydrochloride Enteric Capsules
Levomilnacipran Hydrochloride Extended-Release CapsulesExperimentalNot described
Receives: Drug: Levomilnacipran Hydrochloride Extended-Release Capsules

What is being measured

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

  1. The change from baseline in the total score of the 17-item Hamilton Depression Rating Scale (HAM-D17) after 8 weeks of treatment.

    Change from baseline at Week 8 in total score of the 17-item Hamilton Depression Rating Scale (HAM-D17) (Score range: 0-52; a higher score indicates greater severity of depressive symptoms.)

    Measured: 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.

  1. First posted28 Nov 2025
  2. Study start17 Oct 2024
  3. Primary completion13 Jun 2025
  4. Study completion22 Jul 2025

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
392 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07253207
Sponsor's protocol ID
HH-ZMNPL-2024
Status last verified
Nov 2025
First submitted
18 Nov 2025
Last updated
28 Nov 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Levomilnacipran Hydrochloride Extended-Release Capsules and Duloxetine Hydrochloride Enteric Capsules in people with Major Depressive Disorder (MDD), run by Zhejiang Huahai Pharmaceutical Co., Ltd. at 28 sites 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 7 inclusion and 25 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 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

The change from baseline in the total score of the 17-item Hamilton Depression Rating Scale (HAM-D17) after 8 weeks of treatment. (time frame: 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 NCT07253207.

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 28 Nov 2025.

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