Bipolar disorder
Conditions
Interventions
1:Paliperidone Extended-Release Tablets combined with placebo
3:Paliperidone Extended-Release Tablets combined with sodium valproate
Sponsors
First Affiliated Hospital, College of Medicine, Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. patients aged between 18-45 years old, males and females; Outpatient or hospitalization; 2. patients with a DSM-IV clinical criteria for bipolar disorder type?manic episode; 3. Before entering the group of patients with at least 3 years experience a manic or mixed episodes and need treatment; 4. Young's manic scale into the group and the baseline (YMRS) total scores = 20; 5. Patients and legal guardian can read, understand and sign the informed consent; 6. For female subjects, in the course of the study, agreed that effective contraceptive measures taken in before entering the group and the whole test process. With the fertility of female subjects at the time of screening urine pregnancy test must be negative.
Exclusion criteria
Exclusion criteria: 1) Determine the existence of violence or self injurious behavior, or significantly with violence or self harm tendency; 2) The dsm-iv diagnosis of other mental disorders; 3) with severe physical illness; 4) near or with antisocial personality disorder; 5) into the group of continuous use of benzodiazepines drugs before the equivalent dose of lorazepam 4 mg/d or more than 3 months; 6) within 3 months prior to screening, treatment with clozapine system, or risperidone microsphere for injection;Within a month before the screening, the use of any long-term typical antipsychotic drugs; 7) once or existing tardive dyskinesia symptoms of patients; 8) had antipsychotic drugs in patients with a history of malignant syndrome (NMS); 9) pregnant or breastfeeding women patients; 10) according to the dsm-iv diagnostic criteria, the subjects are using other psychoactive substances or other substances known to have been relying in the past six months, such as heroin, cocaine, and alcohol addiction, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the score of PANSS;the score of YMR; | — |
Secondary
| Measure | Time frame |
|---|---|
| the score of MARD; | — |
Countries
China
Contacts
Public ContactHuang Manli
First Affiliated Hospital, College of Medicine, Zhejiang University
Outcome results
None listed