Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| SMHC-100 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Shanghai Hotmed Sciences Co.,LTD | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary objective of this study is to evaluate the efficacy and safety of Intramuscular Levosulpiride in the treatment of Chinese patients with Agitation Of Schizophrenia compared with Intramuscular Haloperidol by evaluating the change of PANSS-EC total scores at end of study (72 hours after first dosing) from baseline.
Secondary Outcome Measures:
To evaluate the change of Agitation Calmness Evaluation Scale(ACES), Clinical Global Impression(CGI, including CGI-S and CGI-I),PANSS total scores,Brief Psychiatric Rating Scale(BPRS) total scores and every item of PANSS-EC from baseline to the end of study (Time Frame: 72 hours) [ Designated as safety issue: No ]
To evaluate the change of patients' main complain, physical examination, lab and ECG tests, AE、Rating Scale for Extrapyramidal Side Effect(RSESE) and Barnes Akathisia Scale(BAS)from baseline to the end of study (Time Frame: 72 hours) [ Designated as safety issue: Yes ]
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Intramuscular Levosulpiride |
|
| 2 | Active Comparator | Intramuscular Haloperidol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intramuscular Haloperidol | Drug | 1ml:5mg/ampoul the recommended dose is 10 mg per day administered. Doses of 10 mg may be administered 5mg bid with an interval longer than 4 hours for 3 days. |
| Measure | Description | Time Frame |
|---|---|---|
| the change of PANSS-EC total scores | from baseline to the end of study(72 hours after first dosing) |
| Measure | Description | Time Frame |
|---|---|---|
| the change of Agitation Calmness Evaluation Scale(ACES) | from baseline to the end of study (72 hours after first dosing) | |
| The Change of Clinical Global Impression(CGI, including CGI-S and CGI-I) | from baseline to the end of study (72 hours after first dosing) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Huafang LI, MD,PhD | Drug Clinical Trial Office, Shanghai Mental Health Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hebei Mental Health Center | Baoding | Hebei | 071000 | China | ||
| Nanjing Brain Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Intramuscular Levosulpiride | Drug | 2ml:50mg/ampoul the recommended dose is 100 mg per day administered. Doses of 100 mg may be administered 50mg bid with an interval longer than 4 hours for 3 days. |
|
|
| the change of PANSS total scores | from baseline to the end of study (72 hours after first dosing) |
| the change of Brief Psychiatric Rating Scale(BPRS) total scores | from baseline to the end of study (72 hours after first dosing) |
| the change of every item of PANSS-EC | from baseline to the end of study (72 hours after first dosing) |
| the change of Rating Scale for Extrapyramidal Side Effect(RSESE) | from baseline to the end of study (72 hours after first dosing) |
| the change of Barnes Akathisia Scale(BAS) | from baseline to the end of study (72 hours after first dosing) |
| Nanjing |
| Jiangsu |
| 210029 |
| China |
| Xi'an Mental Health Center | Xi'an | Shaanxi | 710061 | China |
| Shanghai Mental Health Center | Shanghai | Shanghai Municipality | 200030 | China |
| The First Affilliated Hospital Of Kunming Medical College | Kunming | Yunnan | 650032 | China |
| ID | Term |
|---|---|
| D011595 | Psychomotor Agitation |
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D011596 | Psychomotor Disorders |
| D019954 | Neurobehavioral Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000096762 | Aberrant Motor Behavior in Dementia |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided