NCT05633108

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
579,728

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 21, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 1, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

March 30, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

November 18, 2023

Status Verified

October 1, 2023

Enrollment Period

6 months

First QC Date

November 21, 2022

Last Update Submit

November 16, 2023

Conditions

Psychotic Disorders

Keywords

SchizophreniaSchizotypal disordersSchizoaffective disordersPersistent or acute or induced or non-organic delusional disordersRecurrent depressive disorder

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (18)

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

    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

    From 1 January 2014 to 31 December 2020

  • Number of Participants With Hepatic, Glycaemia, Cardiovascular, Lipidic Anomalies Assessments

    From 1 January 2014 to 31 December 2020

  • Number of Participants With Loxapac Treatment Episodes

    From 1 January 2014 to 31 December 2020

  • Number of Participants With Off-drug Loxapac Treatment Period

    From 1 January 2014 to 31 December 2020

  • +13 more secondary outcomes

Study Arms (1)

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.

Other: No Intervention

Interventions

No InterventionOTHER

No intervention will be administered.

All Participants

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eisai Ltd. European Knowledge Centre

Hatfield, Hertfordshire, AL10 9SN, United Kingdom

Location

MeSH Terms

Conditions

Psychotic DisordersSchizophreniaDepressive Disorder

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersMood Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2022

First Posted

December 1, 2022

Study Start

March 30, 2023

Primary Completion

September 30, 2023

Study Completion

September 30, 2023

Last Updated

November 18, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will share

Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.

Locations

GB(1)