Clinical trial NCT05633108: A Study Based on the French National Health Insurance Database in Participants With Psychotic Disorders
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psychotic Disorders
Keywords: Schizophrenia
Schizotypal disorders
Schizoaffective disorders
Persistent or acute or induced or non-organic delusional disorders
Recurrent depressive disorder
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2022-12-01
Enrollment: 579728
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All participants hospitalized with a diagnosis of a psychotic disorder will be included in this study at any time between 1 January 2014 and 31 December 2020.

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).


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, 2020.
* 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, 2020.
* 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.

Primary outcomes:
measure: Time from Discharge from a Psychiatric Hospitalization to the Next Psychiatric Rehospitalization
timeFrame: From 1 January 2014 to 31 December 2020
Secondary outcomes:
measure: Percentage of Participants Using Loxapac as Monotherapy or With Other Antipsychotic Polypharmacy Medication
timeFrame: From 1 January 2014 to 31 December 2020
measure: Number of Participants With Consultations Based on a Hospital Psychiatrists, General Practitioner, Private Psychiatric Practitioner or Other Private Specialist
timeFrame: From 1 January 2014 to 31 December 2020
measure: Number of Participants With Hepatic, Glycaemia, Cardiovascular, Lipidic Anomalies Assessments
timeFrame: From 1 January 2014 to 31 December 2020
measure: Number of Participants With Loxapac Treatment Episodes
timeFrame: From 1 January 2014 to 31 December 2020
measure: Number of Participants With Off-drug Loxapac Treatment Period
timeFrame: From 1 January 2014 to 31 December 2020
measure: Duration of Loxapac Treatment
timeFrame: From 1 January 2014 to 31 December 2020
measure: Percentage of Days Covered (PDC) With Loxapac Treatment
timeFrame: From 1 January 2014 to 31 December 2020
measure: Medical Possession Ratio (MPR)
timeFrame: From 1 January 2014 to 31 December 2020
measure: Fixed Medical Possession Ratio (FMPR)
timeFrame: From 1 January 2014 to 31 December 2020
measure: Number of Participants Categorized Based on all Hospitalizations, Psychiatric and Other Hospitalizations
timeFrame: From 1 January 2014 to 31 December 2020
measure: Number of Participants With Passage Through Emergency Department of Hospital
timeFrame: From 1 January 2014 to 31 December 2020
measure: Number of Participants Using Different Antipsychotic Medications
timeFrame: From 1 January 2014 to 31 December 2020
measure: Cumulative Duration of Loxapac as Monotherapy
timeFrame: From 1 January 2014 to 31 December 2020
measure: Cumulative Duration of an Atypical/Typical Antipsychotic Drug Taken as Monotherapy Other Than Loxapac
timeFrame: From 1 January 2014 to 31 December 2020
measure: Cumulative Duration of Anti-Psychotic Biotherapy
timeFrame: From 1 January 2014 to 31 December 2020
measure: Cumulative Duration of Loxapac and an Atypical/Typical Antipsychotic Therapy
timeFrame: From 1 January 2014 to 31 December 2020
measure: Cumulative Duration of Other Antipsychotic Polypharmacy
timeFrame: From 1 January 2014 to 31 December 2020
measure: Cumulative Duration of Periods Without any Antipsychotic Treatment
timeFrame: From 1 January 2014 to 31 December 2020
Other outcomes:
Locations:
city: Hatfield
country: United Kingdom
facility: Eisai Ltd. European Knowledge Centre
state: Hertfordshire
Study officials:
References: