SchizophreniaNCT01362426
Paliperidone Palmitate Effectiveness Assessment Registry - Longitudinal (PEARL)
An observational study of Schizophrenia, run by Janssen-Cilag Pty Ltd at 10 sites in Australia.
Trial summary
The primary objective of this study is to determine if Australian patients with schizophrenia treated with paliperidone palmitate under conditions of continuous monitoring of outcomes over a 12-month period achieve relapse rates comparable to published literature. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- paliperidone palmitate
- How many people
- 127 participants
- Where
- 10 sitesAustralia
- Study dates
- Mar 2011to May 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Australian patients with schizophrenia will be enrolled in the registry
Who may be able to join
- Must fulfill the diagnostic criteria for Schizophrenia Disorders as defined by Diagnostic and Statistical Manual of Mental Disorders Version IV (DSM-IV)
- Must meet the approved Therapeutic Goods Administration (TGA) indication for injectable paliperidone palmitate
- Must have provided written informed consent indicating that they understand the purpose of and procedures required for the registry and are willing to participate in the registry.
Who cannot join
- Those with a known hypersensitivity to either paliperidone or risperidone, or to any excipients in the paliperidone palmitate formulation
- Employees of the clinician or study centre, with direct involvement in the proposed registry or other studies under the direction of that clinician or study centre, as well as family members of the employees or the clinician.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Australia10 sites
Study site
Bendigo
Study site
Box Hill
Study site
Elizabeth Vale
Study site
Epping
Study site
Fitzroy
Study site
Fremantle
Study site
Glenside
Study site
Meadowbrook
Study site
Waratah
Study site
Wollongong
About this study
Official title: A Quality Use of Medicine Clinical Registry to Assess Clinical Outcomes in Patients With Schizophrenia Treated With Intramuscular Injections of Paliperidone Palmitate
The primary objective of this study is to determine if Australian patients with schizophrenia treated with paliperidone palmitate under conditions of continuous monitoring of outcomes over a 12-month period achieve relapse rates comparable to published literature.
Read the detailed description
This study involves the establishment of PEARL, an Australian Quality Use of Medicine clinical registry designed to collect clinical and social data on up to 300 patients with schizophrenia for a 12-month period after initiating treatment with intramuscular (IM) injections of paliperidone palmitate as part of their routine clinical care. Continuous feedback of clinical outcomes will be via regular reports to all registry sites. Enrollment in PEARL should be considered only after the clinical decision to prescribe IM paliperidone palmitate has already been made because the treating physician has determined that this treatment is the best option for the patient. Observational Study - No investigational drug administered
- Conditions
- Schizophrenia
- Being tested
- paliperidone palmitate
- Keywords
- schizophrenia, paliperidone palmitate, INVEGA SUSTENNA, registries, quality of healthcare
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paliperidone palmitateDrug
Dosage and administration will be according to the paliperidone palmitate approved Australian Product Information.
| Study group | Role | What they receive |
|---|---|---|
| 001 | paliperidone palmitate Dosage and administration will be according to the paliperidone palmitate approved Australian Product Information. Receives: Drug: paliperidone palmitate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with symptomatic relapse
Measured: Up to 12 months
Secondary outcomes (5)
Clinical effectiveness and social outcomes as measured by the following clinical assessment tools: CGI-S.
Measured: Up to 12 months
Clinical effectiveness and social outcomes as measured by HoNOS.
Measured: Up to 12 months
Clinical effectiveness and social outcomes as measured by PSP.
Measured: Up to 12 months
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Measured: Up to 12 months
Clinical effectiveness and social outcomes as measured by the following clinical assessment tools: GAF
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2011 (estimated)
- Study startMar 2011
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen-Cilag Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen-Cilag Pty Ltd Clinical Trial, Study director, Janssen-Cilag Pty Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01362426
- Sponsor's protocol ID
- CR018013
- Status last verified
- Mar 2016
- First submitted
- 26 May 2011
- Last updated
- 10 Mar 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Quality Use of Medicine Clinical Registry to Assess Clinical Outcomes in Patients With Schizophrenia Treated With Intramuscular Injections of Paliperidone Palmitate
- ClinicalTrials.gov ID
- NCT01362426
- Acronym / sponsor ID
- CR018013
- Conditions
- Schizophrenia
- Keywords
- schizophrenia, paliperidone palmitate, INVEGA SUSTENNA, registries, quality of healthcare
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Janssen-Cilag Pty LtdIndustry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 30 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to determine if Australian patients with schizophrenia treated with paliperidone palmitate under conditions of continuous monitoring of outcomes over a 12-month period achieve relapse rates comparable to published literature.
Detailed description
This study involves the establishment of PEARL, an Australian Quality Use of Medicine clinical registry designed to collect clinical and social data on up to 300 patients with schizophrenia for a 12-month period after initiating treatment with intramuscular (IM) injections of paliperidone palmitate as part of their routine clinical care. Continuous feedback of clinical outcomes will be via regular reports to all registry sites. Enrollment in PEARL should be considered only after the clinical decision to prescribe IM paliperidone palmitate has already been made because the treating physician has determined that this treatment is the best option for the patient. Observational Study - No investigational drug administered
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 001 | – | Drug: paliperidone palmitatepaliperidone palmitate Dosage and administration will be according to the paliperidone palmitate approved Australian Product Information. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Australian patients with schizophrenia will be enrolled in the registry
Key inclusion criteria (3 listed)
- Must fulfill the diagnostic criteria for Schizophrenia Disorders as defined by Diagnostic and Statistical Manual of Mental Disorders Version IV (DSM-IV)
- Must meet the approved Therapeutic Goods Administration (TGA) indication for injectable paliperidone palmitate
- Must have provided written informed consent indicating that they understand the purpose of and procedures required for the registry and are willing to participate in the registry.
Key exclusion criteria (2 listed)
- Those with a known hypersensitivity to either paliperidone or risperidone, or to any excipients in the paliperidone palmitate formulation
- Employees of the clinician or study centre, with direct involvement in the proposed registry or other studies under the direction of that clinician or study centre, as well as family members of the employees or the clinician.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| paliperidone palmitateDosage and administration will be according to the paliperidone palmitate approved Australian Product Information. | Drug | 001 |
Primary outcome
Number of patients with symptomatic relapse
Time frame: Up to 12 months
5 secondary outcomes
Clinical effectiveness and social outcomes as measured by the following clinical assessment tools: CGI-S.
Time frame: Up to 12 months
Clinical effectiveness and social outcomes as measured by HoNOS.
Time frame: Up to 12 months
Clinical effectiveness and social outcomes as measured by PSP.
Time frame: Up to 12 months
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: Up to 12 months
Clinical effectiveness and social outcomes as measured by the following clinical assessment tools: GAF
Time frame: Up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2016.
Related trials for Schizophrenia
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen-Cilag Pty Ltd Clinical Trial study director
Janssen-Cilag Pty Ltd
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia, run by Janssen-Cilag Pty Ltd at 10 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with symptomatic relapse (time frame: Up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2016.