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Trial registered on ANZCTR


Registration number
ACTRN12618001113246
Ethics application status
Approved
Date submitted
20/06/2018
Date registered
5/07/2018
Date last updated
5/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effectiveness of long-acting paliperidone palmitate (PP1M) compared with oral antipsychotics on satisfaction, subjective well-being and service engagement in subjects with non-acute but symptomatic schizophrenia.
Scientific title
Efficacy on satisfaction, subjective well-being, and service engagement of long-acting paliperidone palmitate compared with oral antipsychotics: a randomized control study in schizophrenia
Secondary ID [1] 295239 0
None
Universal Trial Number (UTN)
U1111-1215-8560
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
schizophrenia 308407 0
Condition category
Condition code
Mental Health 307398 307398 0 0
Schizophrenia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 301577 0
Treatment: Drugs
Comparator / control treatment
Oral risperidone: 4 mg/day
Oral paliperidone: 6 mg/day.
Patients in the oral treatment group were assigned to different medications according to the randomization procedure.
Control group
Active

Outcomes
Primary outcome [1] 306384 0
Effects of treatment with long-acting paliperidone palmitate vs oral antipsychotics on satisfaction, measured with change of Treatment Satisfaction Questionnaire for Medication (TSQM)

Timepoint [1] 306384 0
Baseline and after 6 months
Primary outcome [2] 306509 0
Effects of treatment with long-acting paliperidone palmitate vs oral antipsychotics on well-being measured with Subjective Well-being under Neuroleptics scale (SWN-K)
Timepoint [2] 306509 0
Baseline and after 6 months
Primary outcome [3] 306510 0
Effects of treatment with long-acting paliperidone palmitate vs oral antipsychotics on service engagement, measured with Service Engagement Scale (SES)
Timepoint [3] 306510 0
Baseline and after 6 months
Secondary outcome [1] 348308 0
Changes in the Clinical Global Impression–Severity and Change (CGI-S and CGI-C)
Timepoint [1] 348308 0
Baseline and after 6 months
Secondary outcome [2] 348713 0
Changes in the Personal and Social Performance (PSP) total score.
Timepoint [2] 348713 0
Baseline and after 6 months

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
We use a central randomisation by the computer with the program Research Randomizer (Urbaniak and Plous, Social Psychology Net- 222 work Wesleyan University, Middletown, CT), a free, web- based service for randomization. This system produces a series of numbers related to each subject for randomization.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Statistical analysis was performed both in the group of patients who completed the trial and in the whole group of patients who were randomized, including drop-outs. In the second group, intention-to-treat (ITT) analysis was performed with the last observation carried forward (LOCF).
Baseline mean scores of rating scales were compared between the two treatment groups with one-way analysis of variance (ANOVA). Comparison of score change at the end of the trial between the two groups was calculated for each rating scale with ANOVA repeated measures. Bonferroni correction was applied to correct for multiple comparisons. Effect size was calculated as eta squared.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 10574 0
Italy
State/province [1] 10574 0
Turin

Funding & Sponsors
Funding source category [1] 299828 0
University
Name [1] 299828 0
Department of Neuroscience, University of Turin
Address [1] 299828 0
Via Cherasco 15, 10126 Turin, Italy
Country [1] 299828 0
Italy
Primary sponsor type
University
Name
Department of Neuroscience, University of Turin
Address
Via Cherasco,15 10126, Turin, Italy
Country
Italy
Secondary sponsor category [1] 299200 0
Hospital
Name [1] 299200 0
AOU Città della Salute e della Scienza
Address [1] 299200 0
Corso Bramante 88, 10126 Turin, Italy
Country [1] 299200 0
Italy

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300707 0
Comitato etico interaziendale Città della Salute, Mauriziano e ASLTO1
Ethics committee address [1] 300707 0
Corso Bramante 88, 10126 Turin, Italy
Ethics committee country [1] 300707 0
Italy
Date submitted for ethics approval [1] 300707 0
11/10/2016
Approval date [1] 300707 0
09/01/2017
Ethics approval number [1] 300707 0
0272566

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 84550 0
Prof Paola Rocca
Address 84550 0
Department of Neuroscience, University of Turin Via Cherasco 15, 10126 Turin, Italy
Country 84550 0
Italy
Phone 84550 0
+39 0116335425
Fax 84550 0
+39 0116335425
Email 84550 0
paola.rocca@unito.it
Contact person for public queries
Name 84551 0
Dr Paola Bozzatello
Address 84551 0
Department of Neuroscience, University of Turin, via Cherasco 15 10126 Turin, Italy
Country 84551 0
Italy
Phone 84551 0
+39 0116335425
Fax 84551 0
+390116335425
Email 84551 0
paola.bozzatello@unito.it
Contact person for scientific queries
Name 84552 0
Prof Silvio Bellino
Address 84552 0
Department of Neuroscience, University of Turin, Via Cherasco 15, 10126 Turin, Italy
Country 84552 0
Italy
Phone 84552 0
+39 0116335425
Fax 84552 0
+39 0116335425
Email 84552 0
silvio.bellino@unito.it

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary