None listed
Conditions
Brief summary
The present open-label, randomized, controlled trial is aimed to evaluate the impact of treatment with once-monthly long-acting paliperidone palmitate (PP1M) compared with oral antipsychotics, paliperidone or risperidone, on satisfaction, subjective well-being and service engagement in subjects with non-acute but symptomatic schizophrenia. 66 consecutive outpatients aged between 18 and 65 years with a diagnosis of schizophrenia were randomly assigned to two arms of treatment for 6 months: paliperidone palmitate (PP) 150 mg/month and oral antipsychotic (risperidone, 4 mg/day; or paliperidone ER, 6 mg/day). Patients were evaluated at baseline and after 6 months with rating scales that measure patients satisfaction, well-being, and service engagement. Moreover clinical global symptomatology and functioning were assessed.
Interventions
Patients were randomly assigned to three arms of treatment for 6 months with the following randomization sequence: 1 paliperidone palmitate (PP1M); 1 oral paliperidone extended release (ER); 1 paliperidone palmitate (PP1M) and 1 oral risperidone. PP1M was initiated, in line with the Summary of the Product Characteristics (SmPC), at a recommended dose of 150 mg equivalent (mg eq) on day 1 and 100 mg eq on day 8 intramuscularly, both given in the deltoid muscle. Subsequently, PP1M was administered
Patients were randomly assigned to three arms of treatment for 6 months with the following randomization sequence: 1 paliperidone palmitate (PP1M); 1 oral paliperidone extended release (ER); 1 paliperidone palmitate (PP1M) and 1 oral risperidone. PP1M was initiated, in line with the Summary of the Product Characteristics (SmPC), at a recommended dose of 150 mg equivalent (mg eq) on day 1 and 100 mg eq on day 8 intramuscularly, both given in the deltoid muscle. Subsequently, PP1M was administered once-monthly (±7 days) (visit days) using flexible maintenance dosages within the range of 50 to 150 mg eq based on the clinical judgment of the treating physician. Patients without documentation of previous risperidone or paliperidone exposure were tested for tolerability with paliperidone ER (3 mg/day) for at least 2 days prior to receiving PP1M. In order to monitor patients' adherence we have planned tight timetable visits in which we asked to family members or caregivers about adherence to treatments.
Sponsors
Department of Neuroscience, University of Turin
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Patients were eligible for study enrolment if they had a diagnosis of schizophrenia, were non-acute but symptomatic and previously unsuccessfully treated with an oral antipsychotic. Participants were required to be stable (i.e. have been on the same oral antipsychotic given for the treatment of schizophrenia in an adequate therapeutic dose and with a change in Clinical Global Impression–Severity [CGI-S] score < 0 = 1 in the 4 weeks before enrolment). Patients were required to have previously received an adequate therapeutic dose of any other oral antipsychotic for a sufficient period of time (at least 1 month) prior to enrolment.
Exclusion criteria
Patients were excluded if they had known hypersensitivity to paliperidone ER or risperidone; had been treated with clozapine or a long-acting injectable antipsychotic during the preceding 3 months; had significant medical illness; tardive dyskinesia; neuroleptic malignant syndrome; high risk for adverse events; self-harm behaviours or substance dependence over the past 6 months (however, occasional substance use was allowed). If patients had been treated with an adequate dosage of an appropriate oral antipsychotic for an adequate period of time, previous antipsychotic treatment could be considered unsuccessful due to various causes, including lack of efficacy, tolerability or safety issues, or lack of compliance.
Outcome results
None listed