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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00256997




Registration number
NCT00256997
Ethics application status
Date submitted
18/11/2005
Date registered
22/11/2005
Date last updated
5/12/2013

Titles & IDs
Public title
A Study of Risperidone Long-Acting Injection Versus Oral Antipsychotics in Schizophrenia Participants With a History of Being Poorly Compliant With Taking Their Medication
Scientific title
Pragmatic Randomized Trial of Risperdal Consta Versus Oral Atypical Antipsychotics in Poorly Adherent Subjects With Schizophrenia in a Routine Care Setting
Secondary ID [1] 0 0
RISSCH4055
Secondary ID [2] 0 0
CR006016
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Risperidone long-acting injection (LAI)
Treatment: Drugs - Oral atypical Antipsychotic

Experimental: Risperidone long-acting injection (LAI) - Risperidone LAI 25 milligram (mg), 37.5 mg or 50 mg intramuscular (injection of a substance into a muscle) injection will be administered every 2 weeks as per Investigator's discretion. An oral atypical antipsychotic will also be administered in the first 3 weeks following the dose increase. Duration of treatment will be 24 months.

Active Comparator: Oral atypical Antipsychotic - Oral atypical antipsychotic will be administered as per local label practice for 24 months. Participants will be switched to another atypical oral therapy as per Investigator's discretion.


Treatment: Drugs: Risperidone long-acting injection (LAI)
Risperidone LAI 25 milligram (mg), 37.5 mg or 50 mg intramuscular (injection of a substance into a muscle) injection will be administered every 2 weeks as per Investigator's discretion. An oral atypical antipsychotic will also be administered in the first 3 weeks following the dose increase. Duration of treatment will be 24 months.

Treatment: Drugs: Oral atypical Antipsychotic
Oral atypical antipsychotic will be administered as per local label practice for 24 months. Participants will be switched to another atypical oral therapy as per Investigator's discretion.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Who Experienced a Clinical Exacerbation From Month 3 Post-Randomization
Timepoint [1] 0 0
Month 3 up to Month 24
Secondary outcome [1] 0 0
Percentage of Participants Who Experienced a Clinical Exacerbation
Timepoint [1] 0 0
Baseline up to Month 24
Secondary outcome [2] 0 0
Time to First Clinical Exacerbation
Timepoint [2] 0 0
Baseline up to Month 24
Secondary outcome [3] 0 0
Time in Symptomatic (Having Symptoms) Remission
Timepoint [3] 0 0
Baseline up to Month 24
Secondary outcome [4] 0 0
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Total Score at Month 24
Timepoint [4] 0 0
Baseline and Month 24
Secondary outcome [5] 0 0
Number of Participants With Clinical Global Impression of Severity (CGI-S)
Timepoint [5] 0 0
Baseline and End of Study (Month 24 or Early Withdrawal [EW])
Secondary outcome [6] 0 0
Number of Participants With Clinical Global Impression of Change (CGI-C)
Timepoint [6] 0 0
End of Study (Month 24 or Early Withdrawal [EW])
Secondary outcome [7] 0 0
Number of Participants With Response to Resource Utilization Questionnaire (RUQ)
Timepoint [7] 0 0
Baseline up to Month 24
Secondary outcome [8] 0 0
Change From Baseline in Assessment of Quality of Life (AQoL) Score at Month 24
Timepoint [8] 0 0
Baseline and Month 24
Secondary outcome [9] 0 0
Change From Baseline in Personal and Social Performance Scale (PSP) Total Score at Month 24
Timepoint [9] 0 0
Baseline and End of Study (Month 24 or Early Termination [ET])

Eligibility
Key inclusion criteria
- Diagnosis of schizophrenia (psychiatric disorder with symptoms of
emotional instability, detachment from reality, often with delusions and hallucinations,
and withdrawal into the self) as per Diagnostic and Statistical Manual of Mental Disorders,
Fourth Edition Text revision (DSM-IV TR)- Have had at least 2 hospitalizations or 2
clinical worsening of symptoms, over the past 2 years because of deteriorating adherence -
Is currently receiving treatment with an antipsychotic per local product label guidelines,
and has a history in the last 5 years of a satisfactory response (minimum of 6 weeks) to
oral antipsychotics (excluding clozapine) - On monotherapy antipsychotic treatment as per
local product label guidelines, at Baseline -Female participants must be surgically
sterile, or practicing an effective method of birth control before entry and throughout the
study, and have a negative urine pregnancy test at screening before study entry
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion
Criteria: - Participants with a primary DSM-IV TR Axis I diagnosis other than schizophrenia
- Female participants who are currently pregnant or breastfeeding or planning a pregnancy
within 2 years of trial start - Have a serious, unstable and untreated medical illnesses,
such as vascular or cardiovascular disease, history of liver or kidney disease, significant
cardiac (having to do with the heart), pulmonary (having to do with the lungs),
gastrointestinal, endocrine, neurological (pertaining to the nervous system) or metabolic
disturbances - At significant risk of suicide or violence at study start - Evidence of
substance dependence (except for nicotine and caffeine dependence) according to DSM-IV TR
criteria diagnosed in the last month prior to entry

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)
Methods used to generate the sequence in which subjects will be randomised (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
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2009
Sample size
Target
Accrual to date
Final
167
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Dandenong
Recruitment hospital [2] 0 0
- Frankston
Recruitment hospital [3] 0 0
- Mt Claremont
Recruitment hospital [4] 0 0
- Newcastle
Recruitment hospital [5] 0 0
- Southport
Recruitment postcode(s) [1] 0 0
- Dandenong
Recruitment postcode(s) [2] 0 0
- Frankston
Recruitment postcode(s) [3] 0 0
- Mt Claremont
Recruitment postcode(s) [4] 0 0
- Newcastle
Recruitment postcode(s) [5] 0 0
- Southport
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Alberta
Country [2] 0 0
Canada
State/province [2] 0 0
New Brunswick
Country [3] 0 0
Canada
State/province [3] 0 0
Nova Scotia
Country [4] 0 0
Canada
State/province [4] 0 0
Ontario
Country [5] 0 0
Canada
State/province [5] 0 0
Quebec
Country [6] 0 0
Canada
State/province [6] 0 0
Saskatchewan
Country [7] 0 0
Canada
State/province [7] 0 0
Montreal
Country [8] 0 0
Canada
State/province [8] 0 0
Saint John
Country [9] 0 0
Ireland
State/province [9] 0 0
Co.Mayo
Country [10] 0 0
Ireland
State/province [10] 0 0
Dublin
Country [11] 0 0
Ireland
State/province [11] 0 0
Mullingar
Country [12] 0 0
United Kingdom
State/province [12] 0 0
Birmingham
Country [13] 0 0
United Kingdom
State/province [13] 0 0
Boston
Country [14] 0 0
United Kingdom
State/province [14] 0 0
Bristol
Country [15] 0 0
United Kingdom
State/province [15] 0 0
Burnley
Country [16] 0 0
United Kingdom
State/province [16] 0 0
Darwen
Country [17] 0 0
United Kingdom
State/province [17] 0 0
Devon
Country [18] 0 0
United Kingdom
State/province [18] 0 0
Grantham
Country [19] 0 0
United Kingdom
State/province [19] 0 0
Leicester
Country [20] 0 0
United Kingdom
State/province [20] 0 0
Lincoln
Country [21] 0 0
United Kingdom
State/province [21] 0 0
London
Country [22] 0 0
United Kingdom
State/province [22] 0 0
Morpeth
Country [23] 0 0
United Kingdom
State/province [23] 0 0
Newcastle Upon Tyne
Country [24] 0 0
United Kingdom
State/province [24] 0 0
Northampton
Country [25] 0 0
United Kingdom
State/province [25] 0 0
Nottingham
Country [26] 0 0
United Kingdom
State/province [26] 0 0
Preston
Country [27] 0 0
United Kingdom
State/province [27] 0 0
Stamford
Country [28] 0 0
United Kingdom
State/province [28] 0 0
Stockton-Upon-Tees
Country [29] 0 0
United Kingdom
State/province [29] 0 0
Swansea
Country [30] 0 0
United Kingdom
State/province [30] 0 0
Teignmouth
Country [31] 0 0
United Kingdom
State/province [31] 0 0
Wallsend
Country [32] 0 0
United Kingdom
State/province [32] 0 0
Weston Super Mare

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Janssen-Ortho Inc., Canada
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate risperidone long-acting injection (an antipsychotic
medication) versus oral antipsychotics in schizophrenia (psychiatric disorder with symptoms
of emotional instability, detachment from reality, often with delusions and hallucinations,
and withdrawal into the self) participants with a history of being poorly compliant with
taking their medication.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00256997
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Inc. Clinical Trial
Address 0 0
Janssen Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00256997