A Phase II Study to Evaluate NH102 for Depression

NCT06842992 | Completed Phase 2

• 1 other identifier: NH102-21
• Study Type: interventional
• Target: 243
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder (MDD)

Outcome Measures

Primary Outcomes (1)

• 17 items Hamilton Depression Scales (HAM-D17)

  Changes from baseline in the 17 items Hamilton Depression Scales (HAM-D17) total score at the end of treatment. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, and weight loss). Nine items are scored on a 3 point scale (0=none/absent to 2=most severe) and 8 items are scored on a 5 point scale (0=none/absent to 4=most severe) for a maximum total score of 50. Higher scores indicate a worse outcome.

  6 Weeks

Secondary Outcomes (6)

• 17 items Hamilton Depression Scales (HAM-D17)

  Week 2 and 4

• Montgomery- Åsberg Depression Rating Scale(MADRS)

  6 Weeks

• Clinical Global Impression-Improvement (CGI-I)

  6 Weeks

• Clinical Global Impression-Severity (CGI-S)

  6 Weeks

• Hamilton Anxiety Rating Scale (HAM-A)

  6 Weeks

Study Arms (5)

NH102 10mg

EXPERIMENTAL

Drug: NH102

NH102 20mg

EXPERIMENTAL

Drug: NH102

NH102 30mg

EXPERIMENTAL

Drug: NH102

Duloxetine Hydrochloride Enteric Capsules

ACTIVE COMPARATOR

Drug: Duloxetine Hydrochloride Enteric-coated Capsule

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

NH102 DRUG

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

NH102 10mg

Duloxetine Hydrochloride Enteric-coated Capsule DRUG

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

Duloxetine Hydrochloride Enteric Capsules

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangsu Nhwa Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Shanghai Mental Health Center

Shanghai, China

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2025
• First Posted: February 24, 2025
• Study Start: December 4, 2024
• Primary Completion: July 30, 2025
• Study Completion: September 12, 2025
• Last Updated: December 1, 2025

Record last verified: 2025-11

Locations

CN (1)