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

Psychotic Disorders Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05633108
• Other study ID #: LOX-M033-501
• Status: Completed
• Start date: March 30, 2023
• Est. completion date: September 30, 2023

Study information

• Verified date: October 2023
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 579728
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Mental Disorders
• Psychotic Disorders

Intervention

Other:
• No Intervention
No intervention will be administered.

Locations

Country	Name	City	State
United Kingdom	Eisai Ltd. European Knowledge Centre	Hatfield	Hertfordshire

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Co., Ltd.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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