A Retrospective Observational Study Based on the French National Health Insurance Database to Describe Antipsychotic Monotherapy and Polypharmacy Use, Including Loxapac, and to Investigate Their Association With Psychiatric Rehospitalization in Patients With Psychotic Disorders

Eisai Co., Ltd.1 site in 1 country579,728 target enrollmentMarch 30, 2023

ConditionsPsychotic Disorders

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Psychotic Disorders
Sponsor: Eisai Co., Ltd.
Enrollment: 579728
Locations: 1
Primary Endpoint: Time from Discharge from a Psychiatric Hospitalization to the Next Psychiatric Rehospitalization
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The primary purpose of the study is to compare therapy with antipsychotic medication (antipsychotic monotherapy or antipsychotic combination) versus no antipsychotic medication, and antipsychotic monotherapy versus antipsychotic combination, regarding time to psychiatric rehospitalization, in participants with a psychotic disorder (that is, schizophrenia, schizotypal disorders, schizoaffective disorders, persistent or acute or induced or non-organic delusional disorders, recurrent depressive disorder with psychotic symptoms).

Registry

clinicaltrials.gov

Start Date

March 30, 2023

End Date

September 30, 2023

Last Updated

2 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Eisai Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•At least one discharge for psychiatric hospitalization with a diagnosis of a psychotic disorder between January 1, 2014 and December 31,
•At least one long-term disease record (LTD), (which is a French administrative status allowing the full reimbursement of the cost of a chronic pathology) with a diagnosis of a psychotic disorder between January 1, 2014 and December 31,
•Age of 18 years or older at index date (first date found in the previous conditions).

Exclusion Criteria

•Due to data management constraint, the participants with multiple or temporary identifiers in the database (indistinguishable in database) will be excluded. This happens with twins or migrants, for example.

Outcomes

Primary Outcomes

Time from Discharge from a Psychiatric Hospitalization to the Next Psychiatric Rehospitalization

Time Frame: From 1 January 2014 to 31 December 2020

Participants will be censored in case of death or lost to follow up or on 31 Dec 2020, whichever occurs first.

Secondary Outcomes

Cumulative Duration of Anti-Psychotic Biotherapy(From 1 January 2014 to 31 December 2020)
Duration of Loxapac Treatment(From 1 January 2014 to 31 December 2020)
Percentage of Days Covered (PDC) With Loxapac Treatment(From 1 January 2014 to 31 December 2020)
Number of Participants With Consultations Based on a Hospital Psychiatrists, General Practitioner, Private Psychiatric Practitioner or Other Private Specialist(From 1 January 2014 to 31 December 2020)
Number of Participants With Passage Through Emergency Department of Hospital(From 1 January 2014 to 31 December 2020)
Cumulative Duration of Periods Without any Antipsychotic Treatment(From 1 January 2014 to 31 December 2020)
Percentage of Participants Using Loxapac as Monotherapy or With Other Antipsychotic Polypharmacy Medication(From 1 January 2014 to 31 December 2020)
Number of Participants With Hepatic, Glycaemia, Cardiovascular, Lipidic Anomalies Assessments(From 1 January 2014 to 31 December 2020)
Number of Participants With Loxapac Treatment Episodes(From 1 January 2014 to 31 December 2020)
Number of Participants With Off-drug Loxapac Treatment Period(From 1 January 2014 to 31 December 2020)
Medical Possession Ratio (MPR)(From 1 January 2014 to 31 December 2020)
Fixed Medical Possession Ratio (FMPR)(From 1 January 2014 to 31 December 2020)
Number of Participants Categorized Based on all Hospitalizations, Psychiatric and Other Hospitalizations(From 1 January 2014 to 31 December 2020)
Cumulative Duration of Loxapac as Monotherapy(From 1 January 2014 to 31 December 2020)
Cumulative Duration of an Atypical/Typical Antipsychotic Drug Taken as Monotherapy Other Than Loxapac(From 1 January 2014 to 31 December 2020)
Cumulative Duration of Loxapac and an Atypical/Typical Antipsychotic Therapy(From 1 January 2014 to 31 December 2020)
Cumulative Duration of Other Antipsychotic Polypharmacy(From 1 January 2014 to 31 December 2020)
Number of Participants Using Different Antipsychotic Medications(From 1 January 2014 to 31 December 2020)