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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NH102 10mg | Experimental |
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| NH102 20mg | Experimental |
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| NH102 30mg | Experimental |
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| Duloxetine Hydrochloride Enteric Capsules | Active Comparator |
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| Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NH102 | Drug | 5 mg twice daily over 6 weeks, followed by a 1-week tapering period. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Mental Health Center | Shanghai | China |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| NH102 |
| Drug |
10 mg twice daily over 6 weeks, followed by a 1-week tapering period. |
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| NH102 | Drug | 15 mg twice daily over 6 weeks, followed by a 1-week tapering period. |
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| Duloxetine Hydrochloride Enteric-coated Capsule | Drug | 30 mg twice daily for 6 weeks, followed by a 1-week tapering period. |
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| Placebo | Drug | Matched dosing regimen.Twice daily for 6 weeks, followed by a 1-week tapering period. |
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| 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). | 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." | 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. | 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. | 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. | 6 Weeks |