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

NCT ID: NCT05633108

Last Updated: 2023-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

579728 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-30

Study Completion Date

2023-09-30

Brief Summary

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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).

Detailed Description

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Conditions

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Psychotic Disorders

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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All Participants

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.

No Intervention

Intervention Type OTHER

No intervention will be administered.

Interventions

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No Intervention

No intervention will be administered.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eisai Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Eisai Ltd. European Knowledge Centre

Hatfield, Hertfordshire, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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LOX-M033-501

Identifier Type: -

Identifier Source: org_study_id

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