Evaluating NH102 for treating major depression

A Multicenter, Randomized, Double-blind, Double-dummy, Placebo and Active-controlled, Dose-exploration Phase II Clinical Trial to Evaluate the Efficacy and Safety of NH102 in the Treatment of Depression

This study is testing a new medication called NH102 to see if it can help people with major depression feel better compared to a standard treatment or a placebo.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 240 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Jiangsu Nhwa Pharmaceutical Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Shanghai)
• Trial ID: NCT06842992 on ClinicalTrials.gov

What this trial studies

This multicenter, randomized, double-blind, double-dummy Phase II clinical trial aims to assess the efficacy and safety of NH102 in patients diagnosed with major depressive disorder (MDD). The study involves a screening period, a 6-week double-blind treatment phase with three different doses of NH102 and a control group receiving duloxetine or placebo, followed by a tapering-off period. A total of 240 participants will be randomly assigned to one of the treatment groups, with regular follow-ups to monitor their progress and safety.

Who should consider this trial

Good fit: Ideal candidates for this study are male and female outpatients aged 18-65 with a diagnosis of major depressive disorder and specific severity criteria.

Not a fit: Patients with treatment-resistant depression or other significant psychiatric disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients suffering from major depressive disorder.

How similar studies have performed: While this approach is being tested in this specific trial, similar studies evaluating new antidepressants have shown promise in the past.

Eligibility criteria

Inclusion Criteria:

* Male and female outpatients aged 18-65 years (inclusive).
* Diagnosis of Major Depressive Disorder (MDD) according to DSM-5 criteria ( without psychotic features).
* Hamilton Depression Rating Scale (HAM-D17) total score ≥ 22 at screening and baseline visits, with item 1 (depressed mood) score ≥ 2.
* Clinical Global Impression-Severity (CGI-S) score ≥ 4 at screening and baseline.
* Negative pregnancy test for women of childbearing potential.
* Willingness to use effective contraception during the trial and for 3 months after the last dose.
* Voluntary participation and signed informed consent.

Exclusion Criteria:

* Duration of the current depressive episode in first-episode patients \< 3 months.
* Treatment-resistant depression (failure of ≥ 2 adequate antidepressant treatments).
* Other psychiatric disorders (e.g., schizophrenia, bipolar disorder, anxiety disorders).
* History of severe neurological diseases, epilepsy, or significant head trauma.
* Unstable or severe cardiovascular, gastrointestinal, or endocrine diseases.
* History of malignancy within the past 2 years.
* History of increased intraocular pressure or untreated narrow-angle glaucoma.
* Abnormal thyroid function not adequately controlled.
* History of severe drug allergies or hypersensitivity to duloxetine or excipients.
* Suicide attempt within the past year or significant suicide risk.
* Substance abuse within the past year or positive at screening drug test.
* Alcohol abuse (≥ 14 units/week) within the past year.
* Previous treatment with duloxetine without adequate response.
* Normative use of antidepressants within 2 weeks prior to screening.
* Use of CYP2D6 or CYP1A2 potent inhibitors/inducers within 2 weeks prior to screening.
* Participation in another clinical trial within the past 3 months.
* Any condition deemed unsuitable by the investigator.

Where this trial is running

Shanghai

• Shanghai Mental Health Center — Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Professor Huafang Li, MD

Conditions Major Depressive Disorder