Schizophrenia or schizoaffective disorder.
Conditions
Interventions
Product Name: RISPERDAL Consta/37,5mg
Product Code: F109
Pharmaceutical Form: Suspension for injection
Product Name: RISPERDAL Consta/50mg
Product Code: F109
Pharmaceutical Form: Suspension for injec
Sponsors
Janssen-Cilag EMEA Medical Affairs
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: male or female subject subject with an acute episode (maximum time of pre-treatment for the episode: 14 days at randomization) age >=18 and =80 at the baseline visit CGI-S >=5 at the baseline visit 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: DSM-IV axis I diagnosis other than schizophrenia or schizoaffective disorder subjects being treated for the acute episode more than 14 days prior to randomization subjects treated with clozapine during the lats two months before randomization or a conventional depot antipsychotic in the last 4 weeks prior to randomization (zuclopenthixol acutard is accepted as acute treatment) subjects who are known non-responders to risperidone proven by adequate drug plasma levels (non-responders due to non-compliance are not excluded) evidence of alcohol or drug abuse or dependence (except for nicotine and caffeine dependence) according to DSM-IV criteria diagnosed in the last month prior to entry pregnant or breast-feeding females have received an experimental drug or used an experimental medical device within 30 days prior to trial entry history of severe drug allergy, drug hypersensitivity or neuroleptic malignant syndrome known clinically significant laboratory abnormalities known clinically significant ECG abnormalities significant physical illness that might interfere with the trial conduct subject with mental retardation known hypersensitivity to risperidone subjects with phenylketonuria subject with acute risk of suicide at study entry employees of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this randomized trial is to investigate whether early initiation of treatment with Risperdal Consta is not inferior to the routine approach with oral treatment for 12 weeks followed by treatment with Risperdal Consta measured as the PANSS reduction from baseline to endpoint (scheduled after 6 months).;Secondary Objective: Secondary objectives are to investigate and to compare : response rates (defined as >= 20%, >= 30%, >= 40% and >= 50% improvement on PANSS total score from baseline to endpoint), remission rates according to the PANSS severity criterion after 3 and 6 months, the number of discontinuations due to lack of efficacy, the number of discontinuations due to adverse events, changes in CGI-S, GAF, SF-12 and patient treatment satisfaction (DAI and UKU-ConSat as optional scales), resource use data, safety/tolerability, in the 2 treatment arms.;Primary end point(s): The primary objective of this randomized trial is to investigate whether early initiation of treatment with Risperdal Consta is not inferior to the routine approach with oral treatment for 12 weeks followed by treatment with Risperdal Consta measured as the PANSS reduction from baseline to endpoint (scheduled after 6 months). | — |
Countries
Denmark, Finland, Italy, Sweden, United Kingdom
Outcome results
None listed