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Completed

NCT Number: NCT05633108

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

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).

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Key information

Conditions

Psychotic Disorders Depressive Disorder Mental Disorders Mood Disorders Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Eisai Ltd. European Knowledge Centre

Hatfield, Hertfordshire, AL10 9SN, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention

Other

No intervention will be administered.

Primary outcomes

  1. 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

  1. Percentage of Participants Using Loxapac as Monotherapy or With Other Antipsychotic Polypharmacy Medication

    Time frame: From 1 January 2014 to 31 December 2020

    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.

  2. Number of Participants With Consultations Based on a Hospital Psychiatrists, General Practitioner, Private Psychiatric Practitioner or Other Private Specialist

    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.

  3. Number of Participants With Hepatic, Glycaemia, Cardiovascular, Lipidic Anomalies Assessments

    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.

  4. Number of Participants With Loxapac Treatment Episodes

    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.

  5. Number of Participants With Off-drug Loxapac Treatment Period

    Time frame: From 1 January 2014 to 31 December 2020

    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.

  6. Duration of Loxapac Treatment

    Time frame: From 1 January 2014 to 31 December 2020

    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.

  7. Percentage of Days Covered (PDC) With Loxapac Treatment

    Time frame: From 1 January 2014 to 31 December 2020

    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.

  8. Medical Possession Ratio (MPR)

    Time frame: From 1 January 2014 to 31 December 2020

    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.

  9. Fixed Medical Possession Ratio (FMPR)

    Time frame: From 1 January 2014 to 31 December 2020

    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.

  10. Number of Participants Categorized Based on all Hospitalizations, Psychiatric and Other Hospitalizations

    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.

  11. Number of Participants With Passage Through Emergency Department of Hospital

    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.

  12. Number of Participants Using Different Antipsychotic Medications

    Time frame: From 1 January 2014 to 31 December 2020

    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.

  13. Cumulative Duration of Loxapac as Monotherapy

    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.

  14. Cumulative Duration of an Atypical/Typical Antipsychotic Drug Taken as Monotherapy Other Than Loxapac

    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.

  15. Cumulative Duration of Anti-Psychotic Biotherapy

    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.

  16. Cumulative Duration of Loxapac and an Atypical/Typical Antipsychotic Therapy

    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.

  17. Cumulative Duration of Other Antipsychotic Polypharmacy

    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.

  18. Cumulative Duration of Periods Without any Antipsychotic Treatment

    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.

Sponsors and collaborators

Lead sponsor

Eisai Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Dec 1, 2022
Registry last updated
Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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