Clinical trial NCT06842992: A Phase II Study to Evaluate NH102 for Depression
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Major Depressive Disorder (MDD)
Lead sponsor: Jiangsu Nhwa Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-02-24
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: 17 items Hamilton Depression Scales (HAM-D17)
timeFrame: 6 Weeks
Secondary outcomes:
measure: 17 items Hamilton Depression Scales (HAM-D17)
timeFrame: Week 2 and 4
measure: Montgomery- Åsberg Depression Rating Scale(MADRS)
timeFrame: 6 Weeks
measure: Clinical Global Impression-Improvement (CGI-I)
timeFrame: 6 Weeks
measure: Clinical Global Impression-Severity (CGI-S)
timeFrame: 6 Weeks
measure: Hamilton Anxiety Rating Scale (HAM-A)
timeFrame: 6 Weeks
measure: Dimensional Anhedonia Rating Scale (DARS)
timeFrame: 6 Weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Mental Health Center
Study officials:
References: