SCHIZOPHRENIA, SCHIZOAFFECTIVE DISORDER
Conditions
Interventions
Trade Name: Risperdal Consta
Product Name: Risperdal Consta 25mg
Product Code: F109
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: risperidone
Concentration unit: mg milligram(s)
C
Sponsors
Janssen-Cilag Medical Affairs EMEA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male or female. - Age at least 18 years. - Diagnosis of schizophrenia or schizoaffective disorder according to the Diagnostic and Statistical Manual of Mental Diseases, Fourth Edition (DSM-IV) - Patients currently treated with oral risperidone, olanzapine or conventional neuroleptic monotherapy at doses not exceeding 6 mg for risperdal, 20 mg for olanzapine or a conversion dose of 10 mg haloperidol for oral conventional agents - 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 sterilisation or abstinence) before entry and throughout the study; and have a negative urine pregnancy test at baseline, before study entry. - Patients need to be stable (judged clinically stable by the investigator and on a stable dose of medication for 4 weeks or longer) but not optimally treated (non satisfactory treatment regarding symptoms or side effects) and living in the same residence for 30 days - 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. - Patient's relative or caregiver has signed an informed consent indicating that he/she is willing to participate in the trial to provide information in case the patient experiences a relapse during the evaluation period. If this relative or caregiver consent cannot be obtained, the patient can still participate in the trial. 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. - Patients treated with other antipsychotics than oral risperidone, olanzapine or conventional oral neuroleptics. - Patients who are known non-responders to previous treatment with at least 2 antipsychotics. - Patients who are known non-responders to quetiapine, aripiprazole or oral risperidone proven by adequate drug plasma levels (non-responders due to non-compliance are not excluded). - Patients treated with mood stabilisers or antidepressants who are not on a stable dose for at least 3 months prior to trial entry. - 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. - Patients having received an experimental drug or used an experimental medical device within 30 days before the planned start of treatment. - History of severe drug allergy, drug hypersensitivity or neuroleptic malignant syndrome. - Clinically significant laboratory abnormalities. - Known clinically significant ECG abnormality. - Patients with mental retardation. - Patients with a known hypersensitivity to risperidone, quetiapine or aripiprazole. - Patients with acute risk of suicide in the investigator opinion at study entry or a history of suicidal attempt(s).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate whether Risperdal Consta provides better efficacy maintenance over 2 years, as measured by the time to relapse, in comparison to the newer oral atypical antipsychotic quetiapine tested in a routine care setting in general psychiatric services.;Secondary Objective: - to investigate remission according to the PANSS scale, suicidal ideation and suicidal behavior, use of health care facilities, tolerability, Quality of Life (QoL) and patients' functionality during long-term treatment with Risperdal Consta in comparison with the oral atypical antipsychotic quetiapine, - to analyze efficacy in patients treated with the oral atypical antipsychotic aripiprazole (if commercially available), - to assess the overall cost of a relapse.;Primary end point(s): Time to relapse. Relapse will be defined according to the following criteria: psychiatric hospitalisation; an increase in level of care is necessary AND a 25% increase in PANSS total score from baseline or an increase of 10 points if baseline score is equal or inferior to 40; significant clinical deterioration defined as a CGI-C score of 6 ('much worse'); deliberate self-injury; emergence of clinically significant suicidal or homicidal ideation; or violent behaviour resulting in significant injury to another person or significant property damage; a required doses higher than the registered dose. The patient must fulfill the criteria for relapse by clinical judgment on 2 consecutive evaluations, 3 to 5 days apart. The first of these visits will be considered as the moment of relapse. | — |
Countries
Czech Republic, Hungary, Italy, Latvia, Spain, Sweden
Outcome results
None listed