schizophrenia
Conditions
Interventions
Group1:Treatment with Paliperidone Extended-Release Tablets
Group2:Treatment with Paliperidone Palmitate Injection(1M)
Group3:Treatment with Paliperidone Palmitate Injection (3M)
Sponsors
The First Hospital Of Hebei Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Man and woman aged 18 to 65 years; 2. Have a current diagnosis of schizophrenia as defined by Diagnostic and Statistical Manual of Mental Disorders Version V (DSM-V); 3.H ave a PANSS total score of = 70 at screening and baseline; 4. If a woman of childbearing potential, she must have a negative serum ß-human chorionic gonadotropin (Beta-hCG) pregnancy test or urine pregnancy test at screening; 4. If a woman, before entry she must be postmenopausal, or Surgically sterile, or using a reliable method of contraception during the study.If a man is heterosexually active with a woman of childbearing potential, he must agree to use a double barrier method of birth control and to not donate sperm during the study and for 3 months after receiving the last dose of study drug; 6. Be willing and be able to finish the questionnaire; 7. Be able to receive injection; 8. Be able to complete all visit during the study; 9. Be medically stable based on physical examination, medical history, vital signs and 12-lead electrocardiogram performed at screening. If there are abnormalities, it only can be included if the investigator judges abnormalities or deviates from normal ranges does not have clinical significance or is reasonable in the study population. This must be recorded in the original documents and signed by investor; 10. Subjects (or their legally-acceptable representatives) must sign an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
Exclusion criteria
Exclusion criteria: 1. Exclusion criteria related mental disease: 1.1. Has a primary active DSM-V diagnosis other than schizophrenia such as:separation disorders, bipolar disorder, depression, schizoaffective disorder, schizophrenic disorder, autism, drug-induced psychiatric disorders; 1.2. DSM-V was diagnosed as active-dependent (without nicotine and caffeine dependence) within 6months of screening. 1.3. Significant risk of suicidal, homicidal, or violent ideation or behavior within 12 months at screening or the investigators clinical assessment; 2. Exclusion criteria related systematic medical history: 2.1. Has evidence of clinically significant cardiovascular, pulmonary, neurological (including epilepsy or severe cerebral blood vessels) nephrotic hepatic, hematologic, endocrine (including investors determined uncontrollable diabetes), immune or other system diseases encephalopathy syndrome, mild to moderate or severe mental retardation, there are any risk factors that can lead to QT interval prolonged, torsade tachycardia or sudden death; 2.2. Has any physical conditions affecting gluteal and deltoid injections; 2.3. Biochemistry, hematology, or urinalysis test results outside the laboratorys normal reference range and considered by the investigator to be clinically significant; 2.4. History or evidence of clinically significant hepatic disease (including aspartate aminotransferase [AST] or alanine aminotransferase [ALT] values more than 2 times the upper limit of normal) at screening; 2.5. White blood cell (WBC) counts below the lower limit of the normal range at screening; 2.6. Has a history of neuroleptic malignant syndrome(NMS)or tardive dyskinesia; 2.7. pregnant or breast-feeding or tend to be pregnancy within 6 months; 2.8. Has been diagnosed with pituitary tumors, gigantism or acromegaly; 3. Exclusion Criteria related to drugs: 3.1. Has known allergies, hypersensitivity (anaphylaxis-type reaction), or intolerance to risperidone or paliperidone or excipients; 3.2. Has received Emission Computed Tomography within 30 days of screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the score of MARS;the score of MSQ; | — |
Secondary
| Measure | Time frame |
|---|---|
| the score of CGI-S;the score of PANSS;the score of PSP; | — |
Countries
China
Contacts
Public ContactJin Guixing
The First Hospital Of Hebei Medical University
Outcome results
None listed