Schizophrenia Spectrum and Other Psychotic DisordersNCT03390712
Mirror-image Study of Paliperidone Palmitate and Risperidone Long-acting Injection
An observational study of Schizophrenia Spectrum and Other Psychotic Disorders, run by Réseau de Santé Vitalité Health Network at 4 sites in Canada.
Trial summary
The primary objective of this single-center multi-site retrospective chart review is to determine if paliperidone palmitate and/or risperidone long-acting injection can decrease the number of psychiatric relapses following their initiation in an inpatient acute psychiatric unit compared to oral antipsychotic therapy… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia Spectrum and Other Psychotic Disorders
- What is being tested?
- Paliperidone Palmitate, Risperidal Consta and Antipsychotic
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 328 participants
- Where
- 4 sitesCanada
- Study dates
- 2 Jan 2018to Dec 2018
- 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 65 years
- All sexes
- Adult, Older adult
Study population: Patients initiated on long-acting injectable anipsychotics from the regional hospitals under the direction of the Vitalité health network.
Who may be able to join
- Patients who were initiated on either Risperidone long-acting injection or Paliperidone palmitate during an acute psychiatric admission for schizophrenia or other psychotic related disorders.
Who cannot join
- Patients who had their long-acting injection stopped prior to the discharge date of their index admission.
- Patients who received a long-acting injection in the year prior to the index admission.
- Patients who had a psychiatric admission to a forensic, rehabilitation or high dependency unit during the observation period prior to or following their index admission.
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
Chaleur Regional Hospital
Bathurst, New Brunswick, E2A 4L7
Campbellton Regional Hospital
Campbellton, New Brunswick, E3N 3H3
Edmundston Regional Hospital
Edmundston, New Brunswick, E3V 4E4
Dr. George-L.-Dumont University Hospital Center
Moncton, New Brunswick, E1C 2Z3
About this study
Official title: Mirror-image Study Exploring Relapse and Resource Utilization of Paliperidone Palmitate and Risperidone Long-acting Injection in Vitalité Health Network Patients
The primary objective of this single-center multi-site retrospective chart review is to determine if paliperidone palmitate and/or risperidone long-acting injection can decrease the number of psychiatric relapses following their initiation in an inpatient acute psychiatric unit compared to oral antipsychotic therapy and determine if one treatment is superior to the other in this regard. This study will utilize a mirror-image design and incorporate up to a 3 years of follow-up following the index admission. Secondary objectives of this study will be to determine the change in hospital resource utilization for psychiatric reasons following treatment initiation, and to determine the difference in time to relapse.
- Being tested
- Paliperidone Palmitate, Risperidal Consta, Antipsychotic
- Keywords
- Paliperidone palmitate, Risperidone long-acting injection, mirror-image
- Medical subject headings
- Schizophrenia Spectrum and Other Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paliperidone PalmitateDrug
Also called Invega Sustenna
Monthly injections
Risperidal ConstaDrug
Also called Risperidone long-acting injection
Bi-weekly injection
AntipsychoticDrug
Also called Oral antipsychotics
Any oral antipsychotic prescribed to be taken on a regular basis prior to the initiation of a long-acting injectable antipsychotic.
| Study group | Role | What they receive |
|---|---|---|
| Paliperidone Palmitate | Patients who have received a minimum of 3 months of treatment with an injection of paliperidone palmitate. Receives: Drug: Paliperidone Palmitate; Drug: Antipsychotic | |
| Risperidone Long-acting injection. | Patients who have received a minimum of 3 months of treatment with Risperidone long-acting injection. Receives: Drug: Risperidal Consta; Drug: Antipsychotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychiatric Relapse
Hospitalizations will be used as a proxy for relapse and the primary endpoint will be the number of hospital admissions following the discharge date of the index admission for up to 3 years compared to an equivalent timeframe prior to the beginning of the index admission (and including the 1st day of the index admission). Patients will be considered eligible for the primary objective after 3 months of continued long-acting injection treatment.
Measured: up to 3 years
Secondary outcomes (2)
Hospital Resource utilization for psychiatric reasons
Number of ER visits for psychiatric reasons, number of days admitted in hospital for psychiatric reasons.
Measured: up to 3 years
Time to relapse
time following discharge of index admission until the subsequent admission for psychiatric reasons (in days); time following discharge of index admission until the subsequent ER visit for psychiatric reasons (in days).
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2018
- Study start2 Jan 2018 (estimated)
- Primary completionSep 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophrenia Spectrum and Other Psychotic DisordersStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 328 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Réseau de Santé Vitalité Health Network
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen Inc.
- Responsible party
- Principal investigator, Michael Kemp, Réseau de Santé Vitalité Health Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03390712
- Sponsor's protocol ID
- PHAR-1701
- Status last verified
- Dec 2017
- First submitted
- 28 Dec 2017
- Last updated
- 4 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mirror-image Study Exploring Relapse and Resource Utilization of Paliperidone Palmitate and Risperidone Long-acting Injection in Vitalité Health Network Patients
- ClinicalTrials.gov ID
- NCT03390712
- Acronym / sponsor ID
- PHAR-1701
- Keywords
- Paliperidone palmitate, Risperidone long-acting injection, mirror-image
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 328 participants (estimated)
- Lead sponsor
- Réseau de Santé Vitalité Health NetworkUniversity, hospital or other
- Collaborators
- Janssen Inc.
- Study start
- 2 Jan 2018 (estimated)
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 4 Jan 2018 (actual)
- 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 single-center multi-site retrospective chart review is to determine if paliperidone palmitate and/or risperidone long-acting injection can decrease the number of psychiatric relapses following their initiation in an inpatient acute psychiatric unit compared to oral antipsychotic therapy and determine if one treatment is superior to the other in this regard. This study will utilize a mirror-image design and incorporate up to a 3 years of follow-up following the index admission. Secondary objectives of this study will be to determine the change in hospital resource utilization for psychiatric reasons following treatment initiation, and to determine the difference in time to relapse.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paliperidone Palmitate | – | Drug: Paliperidone Palmitate, Drug: AntipsychoticPatients who have received a minimum of 3 months of treatment with an injection of paliperidone palmitate. |
| Risperidone Long-acting injection. | – | Drug: Risperidal Consta, Drug: AntipsychoticPatients who have received a minimum of 3 months of treatment with Risperidone long-acting injection. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients initiated on long-acting injectable anipsychotics from the regional hospitals under the direction of the Vitalité health network.
Key inclusion criteria (1 listed)
- Patients who were initiated on either Risperidone long-acting injection or Paliperidone palmitate during an acute psychiatric admission for schizophrenia or other psychotic related disorders.
Key exclusion criteria (3 listed)
- Patients who had their long-acting injection stopped prior to the discharge date of their index admission.
- Patients who received a long-acting injection in the year prior to the index admission.
- Patients who had a psychiatric admission to a forensic, rehabilitation or high dependency unit during the observation period prior to or following their index admission.
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 PalmitateAlso: Invega SustennaMonthly injections | Drug | Paliperidone Palmitate |
| Risperidal ConstaAlso: Risperidone long-acting injectionBi-weekly injection | Drug | Risperidone Long-acting injection. |
| AntipsychoticAlso: Oral antipsychoticsAny oral antipsychotic prescribed to be taken on a regular basis prior to the initiation of a long-acting injectable antipsychotic. | Drug | Paliperidone Palmitate, Risperidone Long-acting injection. |
Primary outcome
Psychiatric Relapse
Time frame: up to 3 years
Hospitalizations will be used as a proxy for relapse and the primary endpoint will be the number of hospital admissions following the discharge date of the index admission for up to 3 years compared to an equivalent timeframe prior to the beginning of the index admission (and including the 1st day of the index admission). Patients will be considered eligible for the primary objective after 3 months of continued long-acting injection treatment.
2 secondary outcomes
Hospital Resource utilization for psychiatric reasons
Time frame: up to 3 years
Time to relapse
Time frame: up to 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2018.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 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 Spectrum and Other Psychotic Disorders, run by Réseau de Santé Vitalité Health Network at 4 sites in Canada.
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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 4 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. 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?
Results are not available in the source record.
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?
Psychiatric Relapse (time frame: up to 3 years). 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 4 Jan 2018.