A Phase II Study to Evaluate NH102 for Depression (NH102-21)

Jiangsu Nhwa Pharmaceutical

Status and phase: Completed; Phase 2

Conditions: Major Depressive Disorder (MDD)

Treatments: Drug: Duloxetine Hydrochloride Enteric-coated Capsule; Drug: NH102; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06842992

NH102-21

Details and patient eligibility

About

This study is a multicenter, randomized, double-blind, double-dummy, parallel-group, dose-finding Phase II clinical trial with placebo and active comparator duloxetine . It is designed to preliminarily assess the efficacy and safety of NH102 in patients with major depressive disorder and to provide the basis for the design of Phase III clinical trials.

Full description

This trial consists of three periods: a screening period (up to 2 weeks), a double-blind treatment period (6 weeks), and a tapering-off period/safety follow-up (1 week). The screening period may last up to 14 days and a minimum of 1 day.

Baseline assessments will be conducted prior to randomization to confirm the eligibility of participants. A total of 240 patients with depression will be randomly assigned in a 1:1:1:1:1 ratio to three experimental drug groups (10 mg, 20 mg, and 30 mg), one active control group (duloxetine hydrochloride capsules 60 mg ), or one placebo group. The double-blind treatment period will last for 6 weeks, during which participants will take the assigned medications according to the specified dosing regimen and will be followed up at the end of weeks 1, 2, 4, and 6. After the treatment period, participants will enter a 1-week tapering-off period and will undergo safety follow-up at the end of week 7.

Enrollment: 243 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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243 participants in 5 patient groups, including a placebo group

NH102 10mg

Experimental group

Treatment:

Drug: NH102

Drug: NH102

Drug: NH102

NH102 20mg

Experimental group

Treatment:

Drug: NH102

Drug: NH102

Drug: NH102

NH102 30mg

Experimental group

Treatment:

Drug: NH102

Drug: NH102

Drug: NH102

Duloxetine Hydrochloride Enteric Capsules

Active Comparator group

Treatment:

Drug: Duloxetine Hydrochloride Enteric-coated Capsule

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo