Schizophrenia, schizoaffective disorder MedDRA version: 9.1 Level: LLT Classification code 10039613 Term: Schizo-affective type schizophrenia
Conditions
Interventions
Trade Name: RISPOLEPT CONSTA 25 mg
Product Name: RISPERDAL Consta/25mg
Product Code: F109
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: RISPERIDONE
CAS Number: 106266062
Concentra
Sponsors
Janssen-Cilag Medical Affairs EMEA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male or female - Age >18 years - Primary diagnosis of schizophrenia/schizoaffective disorder according to the Diagnostic and Statistical Manual of Mental Diseases, Fourth Edition (DSM-IV-TR). - Primary diagnosis for less than 2 years following initial diagnosis and treatment. - At least 2 previous psychotic episodes. - Maximum total PANSS score of 80. - Patients who, in the opinion of the investigator, require at least 6 months treatment with antipsychotic medication. - Patients may be currently treated with any antipsychotic (with the exception of clozapine and depot neuroleptics) at doses not exceeding the registered highest recommended dose. - Female patients must be surgically sterile, or practicing an effective method of birth control (e.g. prescription oral contraceptives, contraceptive injections, intra-uterine device, double-barrier method, contraceptive patch, male partner sterilization or abstinence) before entry and throughout the study; and have a negative pregnancy test at baseline, before study entry. - Patients (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. 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-TR Axis I diagnosis other than schizophrenia or schizoaffective disorder. - Patients already on treatment with Risperdal Consta. - Patients requiring treatment at entry with mood stabilizers or antidepressants may enter the study only if a stable dose has been received for 3 months prior to study entry. - Pregnant or breast-feeding females. - Patients who have previously received treatment with clozapine. - Evidence of alcohol or drug dependence (except for nicotine and caffeine dependence according to DSM-IV-TR criteria diagnosed in the last month prior to entry). - History of severe drug allergy, drug hypersensitivity or neuroleptic malignant syndrome. - Known hypersensitivity/intolerance or previous non-response to oral risperidone proven by adequate drug plasma levels (non-responders due to non-compliance are not excluded). - Patients who are known non-responders to previous treatment with at least 2 antipsychotics. - Serious, unstable and untreated medical illnesses. - Patients with conditions and symptoms that are listed in the SmPC under special warnings and special precautions for use. - Patients with mental retardation. - Known clinically significant ECG abnormality. - Patients at acute risk of suicide in the investigators opinion at study entry or history of suicidal attempt(s) in the last 3 months before the study entry. - Patients having received an experimental drug or used an experimental medical device within 30 days before the planned start of treatment. - Patients with known phenylketonuria. - 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: To test the hypothesis that patients with good premorbid functioning, as assessed using the Premorbid Adjustment Scale, will respond better to treatment as measured by changes from baseline on the PANSS total score and CGI-S than patients with poor premorbid functioning.;Secondary Objective: (a) to assess the effectiveness, safety, tolerability, and functioning of patients in the early phase of psychosis who are treated with of Risperdal Consta as follows: Effectiveness: via CGI-S/C, PANSS, retention rate Functioning: (SF-36); rehospitalisation rates Safety and tolerability: via reported adverse events, ESRS and retention rate (b) Examine whether greater insight, as measured by the SAI-E and PANSS, is positively associated with better outcomes;Primary end point(s): Clinical Response (improvement) rate defined as >=20% improvement on PANSS total score from baseline to endpoint. | — |
Countries
Greece, Ireland, Italy, Lithuania, Netherlands, Portugal
Outcome results
None listed