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

NCT03390712 | Unknown FDA Drug

• 1 other identifier: PHAR-1701
• Study Type: observational
• Target: 328
• Locations: 1 country
• Sites: 4

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.

Conditions

Schizophrenia Spectrum and Other Psychotic Disorders

Keywords

Paliperidone palmitate; Risperidone long-acting injection; mirror-image

Outcome Measures

Primary Outcomes (1)

• 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.

  up to 3 years

Secondary Outcomes (2)

• Hospital Resource utilization for psychiatric reasons

  up to 3 years

• Time to relapse

  up to 3 years

Study Arms (2)

Paliperidone Palmitate

Patients who have received a minimum of 3 months of treatment with an injection of paliperidone palmitate.

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.

Drug: Risperidal Consta; Drug: Antipsychotic

Interventions

Paliperidone Palmitate DRUG

Monthly injections

Also known as: Invega Sustenna

Paliperidone Palmitate

Risperidal Consta DRUG

Bi-weekly injection

Also known as: Risperidone long-acting injection

Risperidone Long-acting injection.

Antipsychotic DRUG

Any oral antipsychotic prescribed to be taken on a regular basis prior to the initiation of a long-acting injectable antipsychotic.

Also known as: Oral antipsychotics

Paliperidone Palmitate; Risperidone Long-acting injection.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Réseau de Santé Vitalité Health Network: lead
• Janssen Inc.: collaborator

Study Sites (4)

Chaleur Regional Hospital

Bathurst, New Brunswick, E2A 4L7, Canada

Location

Campbellton Regional Hospital

Campbellton, New Brunswick, E3N 3H3, Canada

Location

Edmundston Regional Hospital

Edmundston, New Brunswick, E3V 4E4, Canada

Location

Dr. George-L.-Dumont University Hospital Center

Moncton, New Brunswick, E1C 2Z3, Canada

Location

MeSH Terms

Conditions

Schizophrenia Spectrum and Other Psychotic Disorders

Interventions

Paliperidone Palmitate; Risperidone; Antipsychotic Agents

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Pyrimidinones; Tranquilizing Agents; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses; Psychotropic Drugs

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Psychiatric Pharmacist and Clinical Researcher

Study Record Dates

• First Submitted: December 28, 2017
• First Posted: January 4, 2018
• Study Start: January 2, 2018
• Primary Completion: September 1, 2018
• Study Completion: December 1, 2018
• Last Updated: January 4, 2018

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (4)