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Mirror-image Study of Paliperidone Palmitate and Risperidone Long-acting Injection

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ClinicalTrials.gov Identifier: NCT03390712
Recruitment Status : Enrolling by invitation
First Posted : January 4, 2018
Last Update Posted : January 4, 2018
Sponsor:
Collaborator:
Janssen Inc.
Information provided by (Responsible Party):
Michael Kemp, Réseau de Santé Vitalité Health Network

Brief 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 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.

Condition or disease Intervention/treatment
Schizophrenia Spectrum and Other Psychotic Disorders Drug: Paliperidone Palmitate Drug: Risperidal Consta Drug: Antipsychotic

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Study Type : Observational
Estimated Enrollment : 328 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Mirror-image Study Exploring Relapse and Resource Utilization of Paliperidone Palmitate and Risperidone Long-acting Injection in Vitalité Health Network Patients
Estimated Study Start Date : January 2, 2018
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Paliperidone Palmitate
Patients who have received a minimum of 3 months of treatment with an injection of paliperidone palmitate.
Drug: Paliperidone Palmitate
Monthly injections
Other Name: Invega Sustenna

Drug: Antipsychotic
Any oral antipsychotic prescribed to be taken on a regular basis prior to the initiation of a long-acting injectable antipsychotic.
Other Name: Oral antipsychotics

Risperidone Long-acting injection.
Patients who have received a minimum of 3 months of treatment with Risperidone long-acting injection.
Drug: Risperidal Consta
Bi-weekly injection
Other Name: Risperidone long-acting injection

Drug: Antipsychotic
Any oral antipsychotic prescribed to be taken on a regular basis prior to the initiation of a long-acting injectable antipsychotic.
Other Name: Oral antipsychotics




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Hospital Resource utilization for psychiatric reasons [ Time Frame: up to 3 years ]
    Number of ER visits for psychiatric reasons, number of days admitted in hospital for psychiatric reasons.

  2. Time to relapse [ Time Frame: up to 3 years ]
    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).



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients initiated on long-acting injectable anipsychotics from the regional hospitals under the direction of the Vitalité health network.
Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03390712


Locations
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Canada, New Brunswick
Chaleur Regional Hospital
Bathurst, New Brunswick, Canada, E2A 4L7
Campbellton Regional Hospital
Campbellton, New Brunswick, Canada, E3N 3H3
Edmundston Regional Hospital
Edmundston, New Brunswick, Canada, E3V 4E4
Dr. George-L.-Dumont University Hospital Center
Moncton, New Brunswick, Canada, E1C 2Z3
Sponsors and Collaborators
Réseau de Santé Vitalité Health Network
Janssen Inc.

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Responsible Party: Michael Kemp, Psychiatric Pharmacist and Clinical Researcher, Réseau de Santé Vitalité Health Network
ClinicalTrials.gov Identifier: NCT03390712     History of Changes
Other Study ID Numbers: PHAR-1701
First Posted: January 4, 2018    Key Record Dates
Last Update Posted: January 4, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Michael Kemp, Réseau de Santé Vitalité Health Network:
Paliperidone palmitate
Risperidone long-acting injection
mirror-image

Additional relevant MeSH terms:
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Paliperidone Palmitate
Schizophrenia
Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Risperidone
Antipsychotic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Serotonin 5-HT2 Receptor Antagonists
Dopamine D2 Receptor Antagonists