SchizophreniaRECONNECT-SNCT01394601
A Study to Observe Real-life Allocation of Antipsychotics in Acute Inpatient Management of Schizophrenia
An observational study of Schizophrenia, run by AstraZeneca at 8 sites in Russia.
Trial summary
RECONNECT-S ALPHA is a multicentre study to observe the management of schizophrenic patients who are hospitalized due to an acutely agitated psychotic episode. The patients should be managed according to normal clinical practice until discharge time. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia
- How many people
- 600 participants
- Where
- 8 sitesRussia
- Study dates
- Aug 2011to Dec 2011
- 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: Clinical Practice
Who may be able to join
- male or female patients,
- 18 years or older,
- meeting the diagnostic criteria for schizophrenia stated in The Diagnostic and Statistical Manual of Mental Disorders,
- meeting 4th edition (DSM-IV) criteria hospitalization due to an acutely agitated psychotic episode.
Who cannot join
- patient in acutely agitated state upon discharge from the hospital,
- current participation in any clinical trial,
- previous enrolment in the present NIS.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Russia8 sites
Research Site
Chita
Research Site
Ivanovo
Research Site
Krasnodar
Research Site
Moscow
Clinical Site
Novosibirsk
Clinical Site
S-Petersburg
Research Site
Samara
Research Site
Yekaterinburg
About this study
Official title: RECONNECT-S ALPHA: A Non-interventional Study to Observe Real-life Allocation of Antipsychotics in the Acute Inpatient Management of Schizophrenia
RECONNECT-S ALPHA is a multicentre study to observe the management of schizophrenic patients who are hospitalized due to an acutely agitated psychotic episode. The patients should be managed according to normal clinical practice until discharge time. Data will be collected by review of medical records of the hospitalisation prior the study visit. During the study the patients will conduct one visit on the day of their discharge after hospitalisation due to an acutely agitated psychotic episode. On the study visit data on demographics, diagnosis and medical history will be recorded. Data on antipsychotic and concomitant medication will be collected by review of medical records.
Read the detailed description
RECONNECT-S ALPHA: A non-interventional study to observe real-life allocation of antipsychotics in the acute inpatient management of schizophrenia
- Conditions
- Schizophrenia
- Keywords
- Antipsychotics, schizophrenia, acute inpatient
- Medical subject headings
- Schizophrenia
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients using of atypical antipsychotics.Daily dosage of atypical antipsychotics Mode of administration of atypical antipsychotics.
Measured: up to 6 months
Secondary outcomes (3)
Treatment with of only one antipsychotic during the hospitalization.Use of psychometric scales to evaluate the disease symptoms. Relationship between the patient characteristics and the use of antipsychotic during hospitalisation and after discharge
Measured: up to 6 months
Number of antipsychotics used during the hospitalization due to an acutely agitated psychotic episode. Use of treatment concomitant to antipsychotics during the hospitalization
Measured: up to 6 months
Relationship between medication used during the hospitalization and prescribed as maintenance antipsychotic medication upon discharge.
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2011 (estimated)
- Study startAug 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alexey Stepanov, Study director, AstraZenecaNikolay Govorin, Principal investigator, Chita State Medical Akademy of Roszdraw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01394601
- Sponsor's protocol ID
- NIS-NRU-ATC-2011/1
- Acronym
- RECONNECT-S
- Status last verified
- Nov 2012
- First submitted
- 12 Jul 2011
- Last updated
- 5 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RECONNECT-S ALPHA: A Non-interventional Study to Observe Real-life Allocation of Antipsychotics in the Acute Inpatient Management of Schizophrenia
- ClinicalTrials.gov ID
- NCT01394601
- Acronym / sponsor ID
- RECONNECT-S / NIS-NRU-ATC-2011/1
- Conditions
- Schizophrenia
- Keywords
- Antipsychotics, schizophrenia, acute inpatient
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 14 Jul 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.
RECONNECT-S ALPHA is a multicentre study to observe the management of schizophrenic patients who are hospitalized due to an acutely agitated psychotic episode. The patients should be managed according to normal clinical practice until discharge time. Data will be collected by review of medical records of the hospitalisation prior the study visit. During the study the patients will conduct one visit on the day of their discharge after hospitalisation due to an acutely agitated psychotic episode. On the study visit data on demographics, diagnosis and medical history will be recorded. Data on antipsychotic and concomitant medication will be collected by review of medical records.
Detailed description
RECONNECT-S ALPHA: A non-interventional study to observe real-life allocation of antipsychotics in the acute inpatient management of schizophrenia
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Clinical Practice
Key inclusion criteria (4 listed)
- male or female patients,
- 18 years or older,
- meeting the diagnostic criteria for schizophrenia stated in The Diagnostic and Statistical Manual of Mental Disorders,
- meeting 4th edition (DSM-IV) criteria hospitalization due to an acutely agitated psychotic episode.
Key exclusion criteria (3 listed)
- patient in acutely agitated state upon discharge from the hospital,
- current participation in any clinical trial,
- previous enrolment in the present NIS.
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
Percentage of patients using of atypical antipsychotics.Daily dosage of atypical antipsychotics Mode of administration of atypical antipsychotics.
Time frame: up to 6 months
3 secondary outcomes
Treatment with of only one antipsychotic during the hospitalization.Use of psychometric scales to evaluate the disease symptoms. Relationship between the patient characteristics and the use of antipsychotic during hospitalisation and after discharge
Time frame: up to 6 months
Number of antipsychotics used during the hospitalization due to an acutely agitated psychotic episode. Use of treatment concomitant to antipsychotics during the hospitalization
Time frame: up to 6 months
Relationship between medication used during the hospitalization and prescribed as maintenance antipsychotic medication upon discharge.
Time frame: up to 6 months
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 5 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.
Alexey Stepanov study director
AstraZeneca
Nikolay Govorin principal investigator
Chita State Medical Akademy of Roszdraw
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia, run by AstraZeneca at 8 sites in Russia.
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 4 inclusion and 3 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 5 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 8 sites in Russia. 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?
Percentage of patients using of atypical antipsychotics.Daily dosage of atypical antipsychotics Mode of administration of atypical antipsychotics. (time frame: up to 6 months). 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 5 Nov 2012.