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The main purpose of this study is to evaluate the efficacy and safety of YZJ-1139 in the short-term treatment of primary chronic insomnia, explore the optimal effective dose, and provide the basis for phase III clinical trials
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| YZJ-1139 10mg | Experimental |
| |
| YZJ-1139 20mg | Experimental |
| |
| YZJ-1139 40mg | Experimental |
| |
| YZJ-1139 60mg | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YZJ-1139 10mg | Drug | YZJ-1139 10mg tablets |
| |
| YZJ-1139 20mg |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep efficiency (SE) monitored by PSG | SE is the percentage of the subject 's total sleep time versus the monitored timeï¼›Changes from baseline (mean of any consecutive 2 days from Day -7 to Day -1) were evaluated separately for all subjects on Day 1 / Day 2, Day 13 / Day 14 of dosing, and for 1/5 subjects in each group on Day 27 / Day 28 of dosing. | Baseline , for all subjects: Day 1 / Day 2,Day 13 / Day 14; for 1/5 subjects: Day 27 / Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Total sleep time (TST), sleep latency (LPS), sleep wake time (WASO), number of sleep awakenings (NAW) monitored by PSG | Changes from baseline (mean of any consecutive 2 days from Day -7 to Da y -1) were evaluated separately for all subjects on Day 1 / Day 2, Day 13 / Day 14 of dosing, and for 1/5 subjects in each group on Day 27 / Day 28 of dosing. | Baseline ; for all subjects: Day 1 / Day 2, Day 13 / Day 14; for 1/5 subjects: Day 27 / Day 28 |
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Inclusion Criteria:
1) The mean LPS of 2 nights is ≥ 30 min, with the LPS ≥ 15 min for any night; 2) And/or the mean WASO of 2 nights is ≥ 30 min, with neither night ≥20 min; 3) The mean SE of 2 nights is ≤ 85%, with the SE ≤ 87.5% for both nights. 4. During the study, the patient agreed to follow the daily bedtime between 9 and 12 pm , stayed in bed for 6.5-9 hours every night, and agreed to refrain from taking a nap.
5. Female subjects are confirmed to be non-pregnant at screening; both men of reproductive potential and women of childbearing potential should agree to use medically acceptable and effective contraception throughout the study and within 1 month after the end of the study.
6. Understand the study procedures and contents, voluntarily participate in the clinical study and sign the written Informed Consent Form (ICF), have good compliance during participation in the study, and are willing to attend the visits
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing HuiLongGuan Hospital | Beijing | China | ||||
| Peking University People's Hospital |
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| Drug |
YZJ-1139 20mg tablets |
|
| YZJ-1139 40mg | Drug | YZJ-1139 40mg tablets |
|
| YZJ-1139 60mg | Drug | YZJ-1139 60mg tablets |
|
| Placebo | Drug | Match placebo tablets |
|
| Evaluation of Sleep Structures Recorded by PSG Monitoring | To evaluate changes from baseline on Day 1 and Day 14 of dosing in all subjects and Day 28 of dosing in 1/5 subjects in each group | Baseline, for all subjects: Day 1, Day 14; for 1/5 subjects: Day 28 |
| Subjective Total Sleep Time (sTST), Subjective Sleep Latency (sTSO) Recorded by Sleep Diary | The mean value at Week 1 and Week 2 for all subjects and the mean value at Week 4 for 1/5 subjects in each group were evaluated for the changes from the baseline value (mean value during the run-in period) | Baseline, for all subjects: Week 1,Week 2, for 1/5 subjects:Week 4 |
| Total sleep time (TST), sleep latency (SL), sleep awakening time (WASO), number of sleep awakenings (NAW) and sleep efficiency (SE) recorded by body movement recorder | According to the index values measured by body movement recorder, the mean value at Week 1, mean value at Week 2 and mean value at Week 4 of medication for 1/5 subjects in each group were taken from all subjects to evaluate the change values from the baseline values (mean value during run-in period), respectively | Baseline, for all subjects:Week 1,Week 2, for 1/5 subjects:Week 4 |
| Insomnia Severity Index (ISI) | Changes from baseline were evaluated separately for all subjects on Day 14 of dosing and for 1/5 subjects in each group on Day 28 of dosing | Baseline, for all subjects: Day 14, for 1/5 subjects:Day 28 |
| Rebound evaluation and proportion of rebound patients | All subjects should receive body movement recorder test and sleep diary during the follow-up period, and each indicator will be compared with the baseline period. If the baseline value is reached or worse than the baseline value, it is defined as rebound | Follow-up Period, 7 days after double-blind treatment. |
| Beijing |
| China |
| Xuanwu Hospital, Capital Medical University | Beijing | China |
| The First Affiliated Hospital of Bengbu Medical College | Bengbu | China |
| The First Hospital of Jilin University | Changchun | China |
| Hunan Brain Hospital | Changsha | China |
| Xiangya Hospital, Central South University | Changsha | China |
| West China Hospital, Sichuan University | Chengdu | China |
| Army Specialty Medical Center | Chongqing | China |
| Guangdong Provincial People's Hospital | Guangzhou | China |
| Nanfang Hospital of Southern Medical University (Department of Psychiatry) | Guangzhou | China |
| Nanfang Hospital, Southern Medical University (Sleep Medicine Center) | Guangzhou | China |
| The First Affiliated Hospital of Jinan University | Guangzhou | China |
| The Second Affiliated Hospital of Anhui Medical University | Hefei | China |
| The Affiliated Hospital of Jiujiang University | Jiujiang | China |
| The First Affiliated Hospital of Kunming Medical University | Kunming | China |
| The First People's Hospital of Yunnan Province | Kunming | China |
| Jiangxi Provincial Psychiatric Hospital | Nanchang | China |
| Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing | Nanjing | China |
| The First People 's Hospital of Nantong | Nantong | China |
| Qingdao Municipal Hospital | Qingdao | China |
| The Second Affiliated Hospital of Fujian Medical University | Quanzhou | China |
| Huashan Hospital Affiliated to Fudan University | Shanghai | China |
| Ruijin Hospital, Shanghai Jiao Tong University School of Medicine | Shanghai | China |
| The First Hospital of Hebei Medical University | Shijiazhuang | China |
| The Third Hospital of Hebei Medical University | Shijiazhuang | China |
| The Second Affiliated Hospital of Soochow University | Suzhou | China |
| Tianjin Anding Hospital | Tianjin | China |
| Wuhan Mental Health Center | Wuhan | China |
| Tangdu Hospital, Fourth Military Medical University, PLA | Xi'an | China |
| The Second Affiliated Hospital of Xinxiang Medical University | Xinxiang | China |
| Henan Provincial People's Hospital | Zhengzhou | China |
| The Affiliated Hospital of Zunyi Medical College | Zunyi | China |
| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
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