Psychotic DisordersNCT05633108
A Study Based on the French National Health Insurance Database in Participants With Psychotic Disorders
An observational study of Psychotic Disorders, run by Eisai Co., Ltd. at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychotic Disorders
- How many people
- 579,728 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Mar 2023to 30 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Eisai Ltd. European Knowledge Centre
Hatfield, Hertfordshire, AL10 9SN
About this study
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
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).
- Conditions
- Psychotic Disorders
- Being tested
- No Intervention
- Keywords
- Schizophrenia, Schizotypal disorders, Schizoaffective disorders, Persistent or acute or induced or non-organic delusional disorders, Recurrent depressive disorder
- Medical subject headings
- Psychotic Disorders, Schizophrenia, Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
No intervention will be administered.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From 1 January 2014 to 31 December 2020
Secondary outcomes (18)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From 1 January 2014 to 31 December 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2022
- Study start30 Mar 2023
- Primary completion30 Sep 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychotic DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 579,728 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05633108
- Sponsor's protocol ID
- LOX-M033-501
- Status last verified
- Oct 2023
- First submitted
- 21 Nov 2022
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05633108
- Acronym / sponsor ID
- LOX-M033-501
- Conditions
- Psychotic Disorders
- Keywords
- Schizophrenia, Schizotypal disorders, Schizoaffective disorders, Persistent or acute or induced or non-organic delusional disorders, Recurrent depressive disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 579,728 participants (actual)
- Lead sponsor
- Eisai Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Mar 2023 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 1 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Participants | – | Other: No InterventionParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No InterventionNo intervention will be administered. | Other | All Participants |
Primary outcome
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.
18 secondary outcomes
Percentage of Participants Using Loxapac as Monotherapy or With Other Antipsychotic Polypharmacy Medication
Time frame: 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
Time frame: From 1 January 2014 to 31 December 2020
Number of Participants With Hepatic, Glycaemia, Cardiovascular, Lipidic Anomalies Assessments
Time frame: From 1 January 2014 to 31 December 2020
Number of Participants With Loxapac Treatment Episodes
Time frame: From 1 January 2014 to 31 December 2020
Number of Participants With Off-drug Loxapac Treatment Period
Time frame: From 1 January 2014 to 31 December 2020
Duration of Loxapac Treatment
Time frame: From 1 January 2014 to 31 December 2020
Percentage of Days Covered (PDC) With Loxapac Treatment
Time frame: From 1 January 2014 to 31 December 2020
Medical Possession Ratio (MPR)
Time frame: From 1 January 2014 to 31 December 2020
Fixed Medical Possession Ratio (FMPR)
Time frame: From 1 January 2014 to 31 December 2020
Number of Participants Categorized Based on all Hospitalizations, Psychiatric and Other Hospitalizations
Time frame: From 1 January 2014 to 31 December 2020
Number of Participants With Passage Through Emergency Department of Hospital
Time frame: From 1 January 2014 to 31 December 2020
Number of Participants Using Different Antipsychotic Medications
Time frame: From 1 January 2014 to 31 December 2020
Cumulative Duration of Loxapac as Monotherapy
Time frame: From 1 January 2014 to 31 December 2020
Cumulative Duration of an Atypical/Typical Antipsychotic Drug Taken as Monotherapy Other Than Loxapac
Time frame: From 1 January 2014 to 31 December 2020
Cumulative Duration of Anti-Psychotic Biotherapy
Time frame: From 1 January 2014 to 31 December 2020
Cumulative Duration of Loxapac and an Atypical/Typical Antipsychotic Therapy
Time frame: From 1 January 2014 to 31 December 2020
Cumulative Duration of Other Antipsychotic Polypharmacy
Time frame: From 1 January 2014 to 31 December 2020
Cumulative Duration of Periods Without any Antipsychotic Treatment
Time frame: From 1 January 2014 to 31 December 2020
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Individual participant dataSharing planned: Yes. Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.
Related trials for Psychotic Disorders
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion
RecruitingPhase 2/3
ACP-204 in Adults With Alzheimer's Disease Psychosis
Alzheimer's Disease Psychosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychotic Disorders, run by Eisai Co., Ltd. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time from Discharge from a Psychiatric Hospitalization to the Next Psychiatric Rehospitalization (time frame: From 1 January 2014 to 31 December 2020). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.