Acute Psychotic EpisodeNCT01491412
Non-interventional Study: Real-life Use of Atypical Antipsychotics in Acute Inpatient Management of Schizophrenia
An observational study of Acute Psychotic Episode and Schizophrenia, run by AstraZeneca at 14 sites in 3 countries.
Trial summary
This is an observational study describing the real-life antipsychotic treatment during the hospitalisation of the patients due to acute psychotic episode. In this NIS subject's data will be collected at one visit at the moment of discharge from the hospital. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Psychotic Episode, Schizophrenia
- How many people
- 503 participants
- Where
- 14 sitesin 3 countries
- Study dates
- Dec 2011to May 2012
- 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: Subjects suffering from schizophrenia being discharged from the hospital following hospitalisation due to acute psychotic episode
Who may be able to join
- Written Informed Consent has been obtained from the Subject and/or his/her legal representative (as per local regulatory requirements).
- Meet the diagnostic criteria for schizophrenia stated in The Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria
- Subject is hospitalised due to an acute psychotic episode
Who cannot join
- Current participation in any clinical trial.
- Previous enrolment in the present NIS (in case of recurrence occurred during the enrolment period)
Trial locations and contacts
14 sites in 3 countries.
14 sites in 3 countries
Hungary7 sites
Research Site
Budapest
Research Site
Debrecen
Research Site
Győr
Research Site
Kistarcsa
Research Site
Nyíregyháza
Research Site
Székesfehérvár
Research Site
Szekszárd
Latvia5 sites
Research Site
Daugavpils
Research Site
Jelgava
Research Site
Liepāja
Research Site
Riga
Research Site
Strenči
About this study
Official title: RECONNECT-S GAMMA : A Non-interventional Study to Observe Real-life Usage of Atypical Antipsychotics in the Acute Inpatient Management of Schizophrenia
This is an observational study describing the real-life antipsychotic treatment during the hospitalisation of the patients due to acute psychotic episode.
In this NIS subject's data will be collected at one visit at the moment of discharge from the hospital.
The results of the study would help to characterise the discrepancy between current clinical practice and treatment guidelines, indicating that atypical antipsychotics are preferable and should be used in monotherapy during acute psychotic episodes in subjects with schizophrenia. Available evidence have revealed a frequent use of first-generation antipsychotics, polypharmacy, intramuscular route of administration and use of atypical antipsychotics in doses lower than recommended in registered summary of product characteristics.
Read the detailed description
RECONNECT-S GAMMA : A non-interventional study to observe real-life usage of atypical antipsychotics in the acute inpatient management of schizophrenia.
- Conditions
- Acute Psychotic Episode, Schizophrenia
- Keywords
- Schizophrenia, antipsychotics, real life treatment, non-interventional
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Acute psychotic episode in schizophrenia | Subjects suffering from schizophrenia being discharged from the hospital following hospitalisation due to acute psychotic episode |
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of used atypical antipsychotic(s) during hospitalisation
The data will be collected at one visit at the moment of discharge from the hospital.
Measured: hospitalisation period, an expected average of 2 weeks (variable per patient)
Description of the daily dosage of atypical antipsychotic(s) during hospitalisation
The data will be collected at one visit at the moment of discharge from the hospital.
Measured: hospitalisation period, an expected average of 2 weeks (variable per patient)
Description of mode of administration of atypical antipsychotic(s) during hospitalisation
The data will be collected at one visit at the moment of discharge from the hospital.
Measured: hospitalisation period, an expected average of 2 weeks (variable per patient)
Secondary outcomes (7)
Percent of patients with atypical antipsychotic as monotherapy
Measured: hospitalisation period, an expected average of 2 weeks (variable per patient)
Percent of patients with combinations of antipsychotics.
Measured: hospitalisation period, an expected average of 2 weeks (variable per patient)
Description of main criteria used for selection of an antipsychotic during hospitalisation.
Measured: hospitalisation period, an expected average of 2 weeks (variable per patient)
Description of the usage of psychometric scales in day to day practice, to evaluate the disease symptoms and thus the efficacy of treatment.
Measured: hospitalisation period, an expected average of 2 weeks (variable per patient)
Description of used concomitant psychiatric medication (other than atypical antipsychotic) during the hospitalization
Measured: hospitalisation period, an expected average of 2 weeks (variable per patient)
Description of the relationship between medication used during the hospitalization and maintenance therapy recommended upon discharge
Measured: hospitalisation period, an expected average of 2 weeks (variable per patient)
Description of the study population by collecting the following exploratory variables: demographic, educational, economical, social data, psychiatric and somatic health.
Measured: hospitalisation period, an expected average of 2 weeks (variable per patient)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2011 (estimated)
- Study startDec 2011
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Psychotic EpisodeStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 503 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Radu TEODORESCU, Prof., Principal investigator, Spitalul Clinic of Psychiatry named after Prof. Dr. Alexandru Obregia, Romania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01491412
- Sponsor's protocol ID
- NIS-NME-SER-2011/1
- Status last verified
- Nov 2012
- First submitted
- 9 Dec 2011
- Last updated
- 30 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RECONNECT-S GAMMA : A Non-interventional Study to Observe Real-life Usage of Atypical Antipsychotics in the Acute Inpatient Management of Schizophrenia
- ClinicalTrials.gov ID
- NCT01491412
- Acronym / sponsor ID
- NIS-NME-SER-2011/1
- Conditions
- Acute Psychotic Episode, Schizophrenia
- Keywords
- Schizophrenia, antipsychotics, real life treatment, non-interventional
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 503 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Dec 2011
- Study completion
- May 2012 (actual)
- First posted
- 14 Dec 2011 (estimated)
- 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.
This is an observational study describing the real-life antipsychotic treatment during the hospitalisation of the patients due to acute psychotic episode.
In this NIS subject's data will be collected at one visit at the moment of discharge from the hospital.
The results of the study would help to characterise the discrepancy between current clinical practice and treatment guidelines, indicating that atypical antipsychotics are preferable and should be used in monotherapy during acute psychotic episodes in subjects with schizophrenia. Available evidence have revealed a frequent use of first-generation antipsychotics, polypharmacy, intramuscular route of administration and use of atypical antipsychotics in doses lower than recommended in registered summary of product characteristics.
Detailed description
RECONNECT-S GAMMA : A non-interventional study to observe real-life usage of atypical antipsychotics in the acute inpatient management of schizophrenia.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute psychotic episode in schizophrenia | – | –Subjects suffering from schizophrenia being discharged from the hospital following hospitalisation due to acute psychotic episode |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects suffering from schizophrenia being discharged from the hospital following hospitalisation due to acute psychotic episode
Key inclusion criteria (3 listed)
- Written Informed Consent has been obtained from the Subject and/or his/her legal representative (as per local regulatory requirements).
- Meet the diagnostic criteria for schizophrenia stated in The Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria
- Subject is hospitalised due to an acute psychotic episode
Key exclusion criteria (2 listed)
- Current participation in any clinical trial.
- Previous enrolment in the present NIS (in case of recurrence occurred during the enrolment period)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Description of used atypical antipsychotic(s) during hospitalisation
Time frame: hospitalisation period, an expected average of 2 weeks (variable per patient)
The data will be collected at one visit at the moment of discharge from the hospital.
Description of the daily dosage of atypical antipsychotic(s) during hospitalisation
Time frame: hospitalisation period, an expected average of 2 weeks (variable per patient)
The data will be collected at one visit at the moment of discharge from the hospital.
Description of mode of administration of atypical antipsychotic(s) during hospitalisation
Time frame: hospitalisation period, an expected average of 2 weeks (variable per patient)
The data will be collected at one visit at the moment of discharge from the hospital.
7 secondary outcomes
Percent of patients with atypical antipsychotic as monotherapy
Time frame: hospitalisation period, an expected average of 2 weeks (variable per patient)
Percent of patients with combinations of antipsychotics.
Time frame: hospitalisation period, an expected average of 2 weeks (variable per patient)
Description of main criteria used for selection of an antipsychotic during hospitalisation.
Time frame: hospitalisation period, an expected average of 2 weeks (variable per patient)
Description of the usage of psychometric scales in day to day practice, to evaluate the disease symptoms and thus the efficacy of treatment.
Time frame: hospitalisation period, an expected average of 2 weeks (variable per patient)
Description of used concomitant psychiatric medication (other than atypical antipsychotic) during the hospitalization
Time frame: hospitalisation period, an expected average of 2 weeks (variable per patient)
Description of the relationship between medication used during the hospitalization and maintenance therapy recommended upon discharge
Time frame: hospitalisation period, an expected average of 2 weeks (variable per patient)
Description of the study population by collecting the following exploratory variables: demographic, educational, economical, social data, psychiatric and somatic health.
Time frame: hospitalisation period, an expected average of 2 weeks (variable per patient)
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 30 Nov 2012.
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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.
Radu TEODORESCU, Prof. principal investigator
Spitalul Clinic of Psychiatry named after Prof. Dr. Alexandru Obregia, Romania
14 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Psychotic Episode and Schizophrenia, run by AstraZeneca at 14 sites in 3 countries.
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 2 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 30 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Hungary, Latvia, Romania. 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?
Description of used atypical antipsychotic(s) during hospitalisation (time frame: hospitalisation period, an expected average of 2 weeks (variable per patient)). The study lists 3 primary outcomes in all. 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 30 Nov 2012.