A Phase II Study to Evaluate NH102 for Depression

NCT ID: NCT06842992

Last Updated: 2025-12-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 243 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-04
• Study Completion Date: 2025-09-12

Brief Summary

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.

Detailed 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.

Conditions

Major Depressive Disorder (MDD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

NH102 10mg

Group Type: EXPERIMENTAL

NH102

Intervention Type: DRUG

5 mg twice daily over 6 weeks, followed by a 1-week tapering period.

NH102 20mg

Group Type: EXPERIMENTAL

NH102

Intervention Type: DRUG

10 mg twice daily over 6 weeks, followed by a 1-week tapering period.

NH102 30mg

Group Type: EXPERIMENTAL

NH102

Intervention Type: DRUG

15 mg twice daily over 6 weeks, followed by a 1-week tapering period.

Duloxetine Hydrochloride Enteric Capsules

Group Type: ACTIVE_COMPARATOR

Duloxetine Hydrochloride Enteric-coated Capsule

Intervention Type: DRUG

30 mg twice daily for 6 weeks, followed by a 1-week tapering period.

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matched dosing regimen.Twice daily for 6 weeks, followed by a 1-week tapering period.

Interventions

NH102

5 mg twice daily over 6 weeks, followed by a 1-week tapering period.

Intervention Type: DRUG

NH102

10 mg twice daily over 6 weeks, followed by a 1-week tapering period.

Intervention Type: DRUG

NH102

15 mg twice daily over 6 weeks, followed by a 1-week tapering period.

Intervention Type: DRUG

Duloxetine Hydrochloride Enteric-coated Capsule

30 mg twice daily for 6 weeks, followed by a 1-week tapering period.

Intervention Type: DRUG

Placebo

Matched dosing regimen.Twice daily for 6 weeks, followed by a 1-week tapering period.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu Nhwa Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shanghai Mental Health Center

Shanghai, , China

Countries

China

Other Identifiers

NH102-21

Identifier Type: -

Identifier Source: org_study_id