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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
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Scientific title
Pragmatic Randomized Trial of Risperdal Consta Versus Oral Atypical Antipsychotics in Poorly Adherent Subjects With Schizophrenia in a Routine Care Setting
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Secondary ID [1]
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RISSCH4055
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Secondary ID [2]
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CR006016
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Schizophrenia
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Condition category
Condition code
Mental Health
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Schizophrenia
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants Who Experienced a Clinical Exacerbation From Month 3 Post-Randomization
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Assessment method [1]
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Clinical exacerbation is defined as hospitalization because of participant's schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, delusions, hallucinations, and self withdrawal) or requiring change from current antipsychotic or initiation of adjunctive antipsychotic, 2-point worsening in Clinical Global Impression of Severity (CGI-S) or emergency room visit, deliberate self-injury, emergence of clinically significant suicidal ideation, utilization of treatment team services, violent behavior, requiring an increase in dose of existing antipsychotic as a result of poor symptom control.
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Timepoint [1]
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Month 3 up to Month 24
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Secondary outcome [1]
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Percentage of Participants Who Experienced a Clinical Exacerbation
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Assessment method [1]
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Clinical exacerbation is defined as hospitalization because of participant's schizophrenia or requiring change from current antipsychotic or initiation of an adjunctive antipsychotic, 2-point worsening in CGI-S or emergency room visit, deliberate self-injury, emergence of clinically significant suicidal ideation, utilization of treatment team services, violent behavior, requiring an increase in dose of existing antipsychotic as a result of poor symptom control.
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Timepoint [1]
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Baseline up to Month 24
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Secondary outcome [2]
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Time to First Clinical Exacerbation
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Assessment method [2]
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Time to first clinical exacerbation was calculated over the entire trial duration wherein clinical exacerbation is defined as hospitalization because of participant's schizophrenia or requiring change from current antipsychotic or initiation of an adjunctive antipsychotic, 2-point worsening in CGI-S or emergency room visit, deliberate self-injury, emergence of clinically significant suicidal ideation, utilization of treatment team services, violent behavior, requiring an increase in dose of existing antipsychotic as a result of poor symptom control.
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Timepoint [2]
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Baseline up to Month 24
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Secondary outcome [3]
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Time in Symptomatic (Having Symptoms) Remission
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Assessment method [3]
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Time in symptomatic (having symptoms) remission for participants on risperidone was compared with those on oral atypical medication and was calculated over the entire trial duration.
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Timepoint [3]
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Baseline up to Month 24
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Secondary outcome [4]
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Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Total Score at Month 24
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Assessment method [4]
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The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210, higher scores indicate worsening.
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Timepoint [4]
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Baseline and Month 24
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Secondary outcome [5]
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Number of Participants With Clinical Global Impression of Severity (CGI-S)
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Assessment method [5]
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The CGI-S rating scale is used to rate the severity of a patient's psychotic condition on a 7-point scale. It is rated as follows: 1=Normal, not at all ill, 2=Borderline mentally ill, 3=Mildly ill, 4=Moderately ill, 5=Markedly ill, 6=Severely ill, and 7=Among the most extremely ill. Higher scores indicate worsening.
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Timepoint [5]
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Baseline and End of Study (Month 24 or Early Withdrawal [EW])
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Secondary outcome [6]
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Number of Participants With Clinical Global Impression of Change (CGI-C)
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Assessment method [6]
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The CGI-C is a assessment of change in global clinical status, defined as a sense of well-being and ability to function in daily activities. CGI-C scores range from 1 (very much improved) through to 7 (very much worse). Higher scores indicate worsening.
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Timepoint [6]
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End of Study (Month 24 or Early Withdrawal [EW])
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Secondary outcome [7]
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Number of Participants With Response to Resource Utilization Questionnaire (RUQ)
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Assessment method [7]
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This questionnaire included questions asked to participants about any hospitalizations, visits to the emergency room or any other psychiatric treatment received in the previous month. Also the participants and/or primary health care contact or caregiver (or other modality to obtain accurate information) were telephoned on a monthly basis (1 month post Visit 2 through to end of study [Visit 6, Month 24]) by a member of the investigational staff and the resource utilization assessment was conducted over the phone.
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Timepoint [7]
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Baseline up to Month 24
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Secondary outcome [8]
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Change From Baseline in Assessment of Quality of Life (AQoL) Score at Month 24
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Assessment method [8]
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AQoL is defined as an Australian-developed participant delivered quality of life (QoL) instrument consisting of 15-questions in 5 scales measuring illness, independence, social relationships, physical senses and psychological well-being. Each of the 5 scales is calculated based on the answers to 3 questions. Each question is given an answer dependent utility score (0 [worst] to 1 [best] and then these scores are combined using a multiplicative model to get the normalized scale score value, each scale ranging between 0.0 (representing death) and 1.0 (representing full health). The scores for independent living, social relationships, physical senses and psychological well-being are combined to obtain the QoL utility score which refers to the "value" of a health state to the respondent where the lower boundary is -0.04 (representing QoL state worse than death), 0.00 (death equivalent QoL state) and to 1.00 (best possible QoL state)".
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Timepoint [8]
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Baseline and Month 24
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Secondary outcome [9]
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Change From Baseline in Personal and Social Performance Scale (PSP) Total Score at Month 24
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Assessment method [9]
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The PSP is 100-point validated clinician-rated scale that assesses degree of difficulty in 4 areas of functioning: socially useful activities, personal and social relationships, self-care, disturbing and aggressive behaviors rated on 6-point scale (1=absent to 6=very severe).Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning, with higher transformed score indicating better function. Total score is divided into 3 levels: 71-100 (mild difficulty); 31-70 (marked difficulty) and 1-30 (severe difficulty).
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Timepoint [9]
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Baseline and End of Study (Month 24 or Early Termination [ET])
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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
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/01/2006
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/04/2009
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Sample size
Target
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Accrual to date
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Final
167
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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- Dandenong
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Recruitment hospital [2]
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- Frankston
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Recruitment hospital [3]
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- Mt Claremont
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Recruitment hospital [4]
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- Newcastle
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Recruitment hospital [5]
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- Southport
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Recruitment postcode(s) [1]
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- Dandenong
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Recruitment postcode(s) [2]
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- Frankston
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Recruitment postcode(s) [3]
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- Mt Claremont
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Recruitment postcode(s) [4]
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- Newcastle
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Recruitment postcode(s) [5]
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- Southport
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Recruitment outside Australia
Country [1]
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Canada
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State/province [1]
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Alberta
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Canada
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State/province [2]
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New Brunswick
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Canada
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State/province [3]
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Nova Scotia
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Country [4]
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Canada
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State/province [4]
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Ontario
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Country [5]
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Canada
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State/province [5]
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Quebec
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Country [6]
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Canada
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State/province [6]
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Saskatchewan
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Country [7]
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Canada
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State/province [7]
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Montreal
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Country [8]
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Canada
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State/province [8]
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Saint John
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Country [9]
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Ireland
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Co.Mayo
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Ireland
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Dublin
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Ireland
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State/province [11]
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Mullingar
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United Kingdom
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Birmingham
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United Kingdom
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Boston
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United Kingdom
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State/province [14]
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Bristol
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United Kingdom
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State/province [15]
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Burnley
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United Kingdom
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Darwen
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United Kingdom
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Devon
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United Kingdom
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Grantham
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United Kingdom
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Leicester
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United Kingdom
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Lincoln
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United Kingdom
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London
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United Kingdom
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Morpeth
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United Kingdom
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Newcastle Upon Tyne
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United Kingdom
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Northampton
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United Kingdom
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Nottingham
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United Kingdom
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Preston
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United Kingdom
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Stamford
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United Kingdom
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Stockton-Upon-Tees
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United Kingdom
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Swansea
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United Kingdom
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State/province [30]
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Teignmouth
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United Kingdom
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State/province [31]
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Wallsend
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Country [32]
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United Kingdom
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State/province [32]
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Weston Super Mare
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Janssen-Ortho Inc., Canada
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Address
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00256997
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Janssen Inc. Clinical Trial
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Address
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Janssen Inc.
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Fax
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00256997
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