Schizophrenia
Conditions
Interventions
Trade Name: Risperdal Consta 25mg
Product Name: RISPERDAL Consta/25mg
Product Code: F109
Pharmaceutical Form: Suspension for injection
Trade Name: Risperdal Consta 37.5 mg
Product Name: RISPERDAL Con
Sponsors
Janssen Cilag Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria Subjects must satisfy the following criteria to be enrolled in the study: 1) Male or female inpatient or outpatient subjects, aged 18 65 years inclusive 2) Diagnosis of schizophrenia as per Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition Text revision (DSM-IV TR)39 3) Female subjects 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 sterilisation or abstinence) before entry and throughout the study; and have a negative urine pregnancy test at screening before study entry 4) Subjects who have had at least 2 hospitalizations or ³ 2 clinical exacerbations (as defined in 3.1) over the past 2 years due to suspected deteriorating adherence 5) In the last 5 years, patient must have demonstrated a satisfactory response (minimum of 6 weeks) to oral antipsychotics (excluding clozapine) to confirm no treatment resistance. 6) Currently on antipsychotic treatment as per local product label guidelines. 7) 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 8)Otherwise healthy as confirmed by physical exam, vital signs and laboratory testing. 9)Subject has an address and access to a telephone 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: Potential subjects who meet any of the following criteria will be excluded from participating in the study: 1) Primary DSM-IV TR Axis I diagnosis other than schizophrenia 2) Subjects previously treated or currently on clozapine 3) Confirmed hypersensitivity or intolerability to risperidone 4) Contraindications for use as listed in the product monographs for risperidone, olanzapine, quetiapine, and where commercially available aripiprazole and amisulpride 5) Female subjects who are currently pregnant or breastfeeding or planning a pregnancy within 2 years of trial start 6) Long acting formulations of neuroleptic medications within 1 treatment cycle of screening 7) Subjects who have failed to respond to 2 or more adequate treatment trials of antipsychotics (an adequate trial is defined as 6 weeks of treatment on the maximum local label dose of the antipsychotic) or 1 adequate trial with oral risperidone. 8) Laboratory abnormality that is deemed clinically significant by the Investigator 9) Serious, unstable and untreated medical illnesses: vascular or cardiovascular disease, history of liver or renal insufficiency, significant cardiac, pulmonary, gastrointestinal, endocrine, neurological or metabolic disturbances 10) Subjects at significant risk of suicide or violence at study start 11) Evidence of alcohol or medication abuse or dependence (except for nicotine and caffeine dependence) according to DSM-IV TR criteria diagnosed in the last month prior to entry 12) Treatment with electroconvulsive therapy (ECT) within 2 years of screening 13) Have received an experimental medication or used an experimental medical device within 30 days before screening. 14) Employees of the investigator or study centre, 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 trial is to determine whether Risperdal* Consta* provides improved effectiveness over a 2 year period, measured by the proportion of subjects who experience a clinical exacerbation, as compared to oral atypical antipsychotics (risperidone, olanzapine, quetiapine, and where commercially available, aripiprazole and amisulpride) prescribed in a routine care setting for the treatment of subjects with schizophrenia. ;Secondary Objective: The secondary objectives are to assess a) the effectiveness of Risperdal* Consta* as measured by symptom improvement PANSS (Positive and Nedgative Symptoms scale) and CGI-S/C) (Clinical Global Impression Severity / Change); b) use of health care resources and assessment of quality of life (Resource Utilization Questionnaire and Assessment Quality Of Life); c) time to first clinical exacerbation; d) number of clinical exacerbations calculated at 2 timepoints: occurring 12 weeks post randomization and the entire trial duration; e) proportion of clinical exacerbations for the entire trial period; f) evaluation of symptomatic remission over time g) Personal and Social Performance Scale (PSP), h) tolerability and safety (AIMS, AE, laboratory tests, vital signs, weight, waist and hip circumference and physical exam).;Primary end point(s): The primary endpoint is the proportion of subjects who experience a clinical exacerbation. Clinical exacerbation will be defined as one of the following: Hospitalization due to an exacerbation of subjects schizophrenia Subjects requiring a change from their current antipsychotic to another antipsychotic treatment or initiation of an adjunctive antipsychotic treatment In addition, a clinical exacerbation will be defined as a 2-point worsening in CGI-S plus at least one of the following: Emergency room visit due to an exacerbation of subjects schizophrenia Utilization of treatment team services (e.g. social worker, case manager, nurse, psychiatrist, family p | — |
Countries
Ireland, United Kingdom
Outcome results
None listed