Subjects 18 years of age or older who meet the DSM-IV criteria for schizophrenia, experiencing an acute schizophrenic episode with a PANSS total score at baseline higher or equal as 70 and admitted to hospital for treatment of the acute schizophrenic episode MedDRA version: 9.1 Level: LLT Classification code 10001065 Term: Acute schizophrenia episode MedDRA version: 9.1 Level: LLT Classification code 10001064 Term: Acute schizophrenia
Conditions
Interventions
Trade Name: INVEGA
Product Name: Paliperidone 3mg Tablet (F039)
Product Code: R076477
Pharmaceutical Form: Tablet
INN or Proposed INN: Paliperidone
CAS Number: 144598-75-4
Current Sponsor code: R07647
Sponsors
Janssen-Cilag International NV, Turnhoutseweg 30, 2340 Beerse, Belgium
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Subject meets the DSM-IV criteria for schizophrenia; - Male or female, aged greater or equal than 18 years; Subject must be experiencing an acute schizophrenic episode with a PANSS total score at baseline greater or equal than 70; - Subject must be admitted to hospital for treatment of the acute schizophrenic episode and must agree for voluntary hospitalization for at least the first 7 days of the study; - Subjects or their legally acceptable representatives must have signed 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; - Female subjects must be postmenopausal (for at least 1 year), surgically sterile, abstinent, or, if sexually active, be practicing and effective method of birth control (e.g. prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization) before entry and throughout the study. Female subjects of child-bearing potential must have a negative urine pregnancy test at screening Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - First antipsychotic treatment ever; - On clozapine or a long-acting injectable antipsychotic during the last 3 months; - Relevant history of any significant and/or unstable cardiovascular, respiratory, neurologic (including seizures or significant cerebrovascular), renal, hepatic, endocrine, or immunologic diseases, including recent or present clinically relevant laboratory abnormalities (as deemed by the investigator); - Known clinically relevant abnormal laboratory values or ECG; - History or current symptoms of tardive dyskinesia; - History of neuroleptic malignant syndrome; - Judged to be at high risk for or presence of violence or self-harm; - Pregnant or breast-feeding female; - Have received an experimental drug or used an experimental medical device within 30 days before the planned start of treatment; - Subjects with a narrowing or blockage of their gastro-intestinal tract; - Inability to swallow the study medication whole with the aid of water (subjects may not chew, divide, dissolve, or crush the study medication, as this may affect the release profile); - Subjects with a current use or known history (over the past 6 months) of substance dependence according to DSM-IV Criteria; - Employees of the investigator or study center, persons with direct involvement in the proposed study or other studies under the direction of that investigator or study center, or family members of the employees or the investigator; - Known hypersensitivity to paliperidone ER or risperidone.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To explore the response to flexible doses of paliperidone ER in acutely exacerbated subjects with schizophrenia. Response is defined as a decrease of at least 30% in total Positive and Negative Syndrome Scale (PANSS) score from baseline to endpoint.;Secondary Objective: To explore efficacy, tolerability, disease severity, functioning, and treatment satisfaction. This is done by: - assessing the efficacy on psychotic symptoms PANSS total score and subscores - assessing the proportion of subjects improving greater or equal than 20%, greater or equal than 40% and greater or equal than 50% in total PANSS from baseline to endpoint; - exploring the onset of efficacy of flexible doses of paliperidone ER (as measured by individual subject’s change in total PANSS score between study visits); - assessing disease severity - assessing personal and social functioning - assessing quality of sleep and daytime drowsiness - assessing treatment satisfaction - assessing extrapyramidal symptoms - assessing side effects profiles by means of physical examination, body weight, vital signs and adverse events (AEs);Primary end point(s): The primary endpoint is defined as a decrease of at least 30% in total Positive and Negative Syndrome Scale (PANSS) score from baseline to endpoint. | — |
Countries
France, Germany, Italy, Lithuania
Outcome results
None listed