A Study Based on the French National Health Insurance Database in Participants With Psychotic Disorders

Study 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).

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

Conditions
-----------------
Psychotic Disorders

Intervention / Treatment
-----------------
* Other: No Intervention


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All Participants<br>Participants diagnosed with psychotic disorder at any time between 1 January 2014 and 31 December 2020 and have data available in French nationwide healthcare data system (SNDS) database during this period will be observed retrospectively. | Other: No Intervention<br>* No intervention will be administered.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time from Discharge from a Psychiatric Hospitalization to the Next Psychiatric Rehospitalization | Participants will be censored in case of death or lost to follow up or on 31 Dec 2020, whichever occurs first. | From 1 January 2014 to 31 December 2020 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Using Loxapac as Monotherapy or With Other Antipsychotic Polypharmacy Medication | Percentage of participants will be reported using Loxapac or other polypharmacy medications, including anti-psychotic medication (typical/atypical); anti-depressants; anti-psychotic medication sedatives (other than benzodiazepines and z-drugs) and with benzodiazepines and z-drugs; anti-psychotic medication and lithium; anti-psychotic medication mood stabilizers; and with at least one other concomitant medication and without concomitant medication. Participants will be censored in case of death or lost to follow up or on 31 Dec 2020, whichever occurs first. | 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 | Participants will be censored in case of death or lost to follow up or on 31 Dec 2020, whichever occurs first. | From 1 January 2014 to 31 December 2020 | 
| Number of Participants With Hepatic, Glycaemia, Cardiovascular, Lipidic Anomalies Assessments | Participants will be censored in case of death or lost to follow up or on 31 Dec 2020, whichever occurs first. | From 1 January 2014 to 31 December 2020 | 
| Number of Participants With Loxapac Treatment Episodes | Participants will be censored in case of death or lost to follow up or on 31 Dec 2020, whichever occurs first. | From 1 January 2014 to 31 December 2020 | 
| Number of Participants With Off-drug Loxapac Treatment Period | The off-drug period is defined as the period between two sequences of Loxapac treatment. Participants will be censored in case of death or lost to follow up or on 31 Dec 2020, whichever occurs first. | From 1 January 2014 to 31 December 2020 | 
| Duration of Loxapac Treatment | The time between the start of each Loxapac sequence since the end of Loxapac sequence, switch to another treatment or end of follow-up. Several sequences may exist for one participant. This outcome will be based on medical possession ratio (MPR). MPR will be calculated using B/D formula. Where, B is number of days of supply of Loxapac and D is number of days between the initiation of Loxapac and the end of follow-up. Participants will be censored in case of death or lost to follow up or on 31 Dec 2020, whichever occurs first. | From 1 January 2014 to 31 December 2020 | 
| Percentage of Days Covered (PDC) With Loxapac Treatment | PDC will be calculated using A/D formula. Where A is number of days covered, that is, number of days of supply of Loxapac without carry-over of overlap days and D is number of days between the initiation of Loxapac and the end of follow-up. Participants will be censored in case of death or lost to follow up or on 31 Dec 2020, whichever occurs first. | From 1 January 2014 to 31 December 2020 | 
| Medical Possession Ratio (MPR) | MPR will be calculated using B/D formula. Where, B is number of days of supply of Loxapac and D is number of days between the initiation of Loxapac and the end of follow-up. Participants will be censored in case of death or lost to follow up or on 31 Dec 2020, whichever occurs first. | From 1 January 2014 to 31 December 2020 | 
| Fixed Medical Possession Ratio (FMPR) | FMPR will be evaluated using MPR and PDC. MPR will be calculated using B/D formula. Where, B is number of days of supply of Loxapac and D is number of days between the initiation of Loxapac and the end of follow-up. PDC will be calculated using A/D formula. Where A is number of days covered, that is, number of days of supply of Loxapac without carry-over of overlap days and D is number of days between the initiation of Loxapac and the end of follow-up. Participants will be censored in case of death or lost to follow up or on 31 Dec 2020, whichever occurs first. | From 1 January 2014 to 31 December 2020 | 
| Number of Participants Categorized Based on all Hospitalizations, Psychiatric and Other Hospitalizations | Participants will be censored in case of death or lost to follow up or on 31 Dec 2020, whichever occurs first. | From 1 January 2014 to 31 December 2020 | 
| Number of Participants With Passage Through Emergency Department of Hospital | Participants will be censored in case of death or lost to follow up or on 31 Dec 2020, whichever occurs first. | From 1 January 2014 to 31 December 2020 | 
| Number of Participants Using Different Antipsychotic Medications | The different antipsychotic medication (other than Loxapac) among the following categories: clozapine, olanzapine, aripiprazole, risperidone, quetiapine, amisulpride, others oral medication. Participants will be censored in case of death or lost to follow up or on 31 Dec 2020, whichever occurs first. | From 1 January 2014 to 31 December 2020 | 
| Cumulative Duration of Loxapac as Monotherapy | Participants will be censored in case of death or lost to follow up or on 31 Dec 2020, whichever occurs first. | From 1 January 2014 to 31 December 2020 | 
| Cumulative Duration of an Atypical/Typical Antipsychotic Drug Taken as Monotherapy Other Than Loxapac | Participants will be censored in case of death or lost to follow up or on 31 Dec 2020, whichever occurs first. | From 1 January 2014 to 31 December 2020 | 
| Cumulative Duration of Anti-Psychotic Biotherapy | Participants will be censored in case of death or lost to follow up or on 31 Dec 2020, whichever occurs first. | From 1 January 2014 to 31 December 2020 | 
| Cumulative Duration of Loxapac and an Atypical/Typical Antipsychotic Therapy | Participants will be censored in case of death or lost to follow up or on 31 Dec 2020, whichever occurs first. | From 1 January 2014 to 31 December 2020 | 
| Cumulative Duration of Other Antipsychotic Polypharmacy | Participants will be censored in case of death or lost to follow up or on 31 Dec 2020, whichever occurs first. | From 1 January 2014 to 31 December 2020 | 
| Cumulative Duration of Periods Without any Antipsychotic Treatment | Participants will be censored in case of death or lost to follow up or on 31 Dec 2020, whichever occurs first. | From 1 January 2014 to 31 December 2020 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Schizophrenia, Schizotypal disorders, Schizoaffective disorders, Persistent or acute or induced or non-organic delusional disorders, Recurrent depressive disorder