Major Depressive Disorder (MDD)Phase 2NH102-21NCT06842992
A Phase II Study to Evaluate NH102 for Depression
A Phase 2 study testing NH102 and Duloxetine Hydrochloride Enteric-coated Capsule in people with Major Depressive Disorder (MDD), run by Jiangsu Nhwa Pharmaceutical Co., Ltd. at 24 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder (MDD)
- What is being tested?
- NH102 and Duloxetine Hydrochloride Enteric-coated Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 243 participants
- Where
- 24 sitesChina
- Study dates
- 4 Dec 2024to 12 Sep 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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 locations and contacts
24 sites in 1 country.
24 sites in 1 country
China24 sites
Hebei Mental Health Hospital
Baoding, Hebei, 071000
Beijing Huilongguan Hospital
Beijing, Beijing Municipality, 100096
Hunan Second people's Hospital
Changsha, Hunan, 410007
The Fourth People's Hospital of Chengdu
Chengdu, Sichuan, 610000
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072
Chongqing Mental Health Center
Chongqing, Chongqing Municipality, 400036
The Affiliated Brain Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510370
Hangzhou Seventh People's Hospital
Hangzhou, Zhejiang, 310003
Anhui Mental Health Center
Hefei, Anhui, 230000
Huzhou Third Municipal Hospital
Huzhou, Zhejiang, 313000
Shongdong Mental Health Center
Jinan, Shandong, 250014
Nanchang Mental Health Center
Nanchang, Jiangxi, 330038
The Affiliated Kangning Hospital of Ningbo University
Ningbo, Zhejiang, 315000
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030
Shenzhen Kangning Hospital
Shenzhen, Guangdong, 518118
Jilin Provincial Neuropsychiatric Hospital
Siping, Jilin, 136000
Suzhou Guangji Hospital
Suzhou, Jiangsu, 215000
Frist Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030000
Tianjin Anding Hospital
Tianjin, Tianjin Municipality, 300000
Wuxi Mental Health Center
Wuxi, Jiangsu, 214000
Xi'an Mental Health Center
Xi’an, Shanxi, 710000
Xiamen Xianyue Hospital
Xiamen, Fujian, 361012
The Second Affiliated Hospital of Henan Medical University
Xinxiang, Henan, 453000
Zhumadian Second People's Hospital
Zhumadian, Henan, 463000
About this study
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
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.
Read the 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)
- Being tested
- NH102, Duloxetine Hydrochloride Enteric-coated Capsule, Placebo
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NH102Drug
5 mg twice daily over 6 weeks, followed by a 1-week tapering period.
NH102Drug
10 mg twice daily over 6 weeks, followed by a 1-week tapering period.
NH102Drug
15 mg twice daily over 6 weeks, followed by a 1-week tapering period.
Duloxetine Hydrochloride Enteric-coated CapsuleDrug
30 mg twice daily for 6 weeks, followed by a 1-week tapering period.
PlaceboDrug
Matched dosing regimen.Twice daily for 6 weeks, followed by a 1-week tapering period.
| Study group | Role | What they receive |
|---|---|---|
| NH102 10mg | Experimental | Not described Receives: Drug: NH102 |
| NH102 20mg | Experimental | Not described Receives: Drug: NH102 |
| NH102 30mg | Experimental | Not described Receives: Drug: NH102 |
| Duloxetine Hydrochloride Enteric Capsules | Active comparator | Not described Receives: Drug: Duloxetine Hydrochloride Enteric-coated Capsule |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 Weeks
Secondary outcomes (6)
17 items Hamilton Depression Scales (HAM-D17)
Changes from baseline in the 17 items Hamilton Depression Scales (HAM-D17) total score at Week 2 and 4.
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.
Measured: Week 2 and 4
Montgomery- Åsberg Depression Rating Scale(MADRS)
Changes from baseline in the 10-items Montgomery- Åsberg Depression Scales (MADRS) total score at Week 2, Week 4 and the end of treatment.
MADRS is a standardized, clinician-administered rating scale that assesses 10 items characteristically associated with major depression. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).
Measured: 6 Weeks
Clinical Global Impression-Improvement (CGI-I)
Changes from baseline in the CGI-I score at the end of treatment.
The Clinical Global Impression-Improvement (CGI-I) scale is a clinician-rated instrument designed to assess the overall improvement or worsening of a patient's condition relative to a baseline state. The following one query is rated on a seven-point scale: "Compared to the patient's condition at admission to the project, this patient's condition is: 1=very much improved since the initiation of treatment; 2=much improved; 3=minimally improved; 4=no change from baseline (the initiation of treatment); 5=minimally worse; 6= much worse; 7=very much worse since the initiation of treatment."
Measured: 6 Weeks
Clinical Global Impression-Severity (CGI-S)
Changes from baseline in the Clinical Global Impression-Severity (CGI-S) score at the end of treatment.
The CGI-S asks the clinician one question: "Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?" which is rated on the following seven-point scale: 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients.
Measured: 6 Weeks
Hamilton Anxiety Rating Scale (HAM-A)
Changes from baseline in the HAM-A total score at the end of treatment.
The Hamilton Anxiety Rating Scale (HAM-A) is a clinician-administered assessment tool to measure the severity of anxiety symptoms. It consists of 14 items, each evaluating a specific symptom of anxiety, such as anxious mood, tension, fears, and somatic complaints. Each item is scored on a scale from 0 (None) to 4 ( Very severe. grossly disabling ), with the total score ranging from a minimum of 0 to a maximum of 56. Higher scores indicate greater severity of anxiety symptoms, reflecting a worse clinical outcome.
Measured: 6 Weeks
Dimensional Anhedonia Rating Scale (DARS)
Change from baseline in Dimensional Anhedonia Rating Scale (DARS) total score at the end of treatment.
The DARS is a self-report scale that measures anhedonia across the following 4 domains: hobbies/past-times, food/drinks, social activities, and sensory experiences. Within each domain, participants are required to provide at least two of their own examples of what they find rewarding. Subsequently, participants answer a set of standardized questions about desire, motivation, effort and consummatory pleasure for the examples provided. Responses were based on a 5-point Likert scale (Not at all=0; Slightly=1; Moderately=2; Mostly=3; Very Much=4), with the total score ranging from a minimum of 0 to a maximum of 68. A higher score reflects a better outcome.
Measured: 6 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2025
- Study start4 Dec 2024
- Primary completion30 Jul 2025
- Study completion12 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive Disorder (MDD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 243 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu Nhwa Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06842992
- Sponsor's protocol ID
- NH102-21
- Acronym
- NH102-21
- Status last verified
- Nov 2025
- First submitted
- 16 Feb 2025
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06842992
- Acronym / sponsor ID
- NH102-21 / NH102-21
- Conditions
- Major Depressive Disorder (MDD)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 243 participants (actual)
- Lead sponsor
- Jiangsu Nhwa Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Dec 2024 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 12 Sep 2025 (actual)
- First posted
- 24 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NH1025 mg twice daily over 6 weeks, followed by a 1-week tapering period. | Drug | NH102 10mg |
| NH10210 mg twice daily over 6 weeks, followed by a 1-week tapering period. | Drug | NH102 20mg |
| NH10215 mg twice daily over 6 weeks, followed by a 1-week tapering period. | Drug | NH102 30mg |
| Duloxetine Hydrochloride Enteric-coated Capsule30 mg twice daily for 6 weeks, followed by a 1-week tapering period. | Drug | Duloxetine Hydrochloride Enteric Capsules |
| PlaceboMatched dosing regimen.Twice daily for 6 weeks, followed by a 1-week tapering period. | Drug | Placebo |
Primary outcome
17 items Hamilton Depression Scales (HAM-D17)
Time frame: 6 Weeks
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 secondary outcomes
17 items Hamilton Depression Scales (HAM-D17)
Time frame: Week 2 and 4
Montgomery- Åsberg Depression Rating Scale(MADRS)
Time frame: 6 Weeks
Clinical Global Impression-Improvement (CGI-I)
Time frame: 6 Weeks
Clinical Global Impression-Severity (CGI-S)
Time frame: 6 Weeks
Hamilton Anxiety Rating Scale (HAM-A)
Time frame: 6 Weeks
Dimensional Anhedonia Rating Scale (DARS)
Time frame: 6 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NH102 and Duloxetine Hydrochloride Enteric-coated Capsule in people with Major Depressive Disorder (MDD), run by Jiangsu Nhwa Pharmaceutical Co., Ltd. at 24 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
17 items Hamilton Depression Scales (HAM-D17) (time frame: 6 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.