SchizophreniaRECONNECT-SNCT01544608
Observe Real-life Allocation of Atypical Antipsychotics in the Acute Inpatient Management of Schizophrenia
An observational study of Schizophrenia, run by AstraZeneca at 7 sites in 3 countries.
Trial summary
The primary objective of this Non- Interventional Study (NIS) is to describe the use of atypical antipsychotics in subjects with Schizophrenia during the hospitalisation due to acute psychotic episode by evaluation of drug, dose and mode of administration of the medication. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia
- How many people
- 1,076 participants
- Where
- 7 sitesin 3 countries
- Study dates
- Jul 2012to Dec 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: Psychiatric Institutes
Who may be able to join
- 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.
- Ability of the subject to understand and comply with the requirements of the study, as judged by the investigator.
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
7 sites in 3 countries.
7 sites in 3 countries
Saudi Arabia3 sites
Research Site
Dammam
Research Site
Jeddah
Research Site
Riyadh
United Arab Emirates3 sites
Research Site
Abu Dhabi
Research Site
Dubai
Research Site
Ras al-Khaimah
About this study
Official title: A Non- Interventional Study to Observe Real Life Usage of Atypical Antipsychotics in the Acute Inpatient Management of Schizophrenia.
The primary objective of this Non- Interventional Study (NIS) is to describe the use of atypical antipsychotics in subjects with Schizophrenia during the hospitalisation due to acute psychotic episode by evaluation of drug, dose and mode of administration of the medication.
Read the detailed description
RECONNECT-S BETA
- Conditions
- Schizophrenia
- Keywords
- Acute psychotic episode of Schizophrenia
- 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 |
|---|---|---|
| Subjects who are hospitalized due to acute psychotic episode. | All subjects who are hospitalized due to acute psychotic episode. The subjects should be managed according to normal clinical practice until discharge time. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Use 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 3 weeks (variable per patient).
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 3 weeks (variable per patient).
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 3 weeks (variable per patient).
Secondary outcomes (6)
Percent of patients with atypical antipsychotic as monotherapy.
The data will be collected at one visit at the moment of discharge from the hospital.
Measured: Hospitalisation period, an expected average of 3 weeks (variable per patient).
Percent of patients with combinations of antipsychotics.
The data will be collected at one visit at the moment of discharge from the hospital.
Measured: Hospitalisation period, an expected average of 3 weeks (variable per patient).
Main criteria of an antipsychotic's selection during hospitalisation expressed as percentage.
The data will be collected at one visit at the moment of discharge from the hospital.
Measured: Hospitalisation period, an expected average of 3 weeks (variable per patient).
Use of psychometric scales in day to day practice in therm of evaluation of the disease symptoms and thus efficacy of the treatment.
The data will be collected at one visit at the moment of discharge from the hospital.
Measured: Hospitalisation period, an expected average of 3 weeks (variable per patient).
Description of the usage of concomitant psychiatric medication (other than atypical antipsychotic) during the hospitalization.
The data will be collected at one visit at the moment of discharge from the hospital.
Measured: Hospitalisation period, an expected average of 3 weeks (variable per patient).
Relationship between medication used during the hospitalization and maintenance therapy recommended upon discharge.
The data will be collected at one visit at the moment of discharge from the hospital.
Measured: Hospitalisation period, an expected average of 3 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 posted6 Mar 2012 (estimated)
- Study startJul 2012
- Primary completionDec 2012
- Study completionDec 2012
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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 1,076 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Talaat Matar, CONSULTANT PSYCHIATRIST, Study chair, Obaid Alla Hospital,Ras Al Khaima,UAETarek Darwish, CONSULTANT PSYCHIATRIST, Study chair, Sheikh Khalifa Medical City(SKMC), Abudhabi,UAESohail Khan, CONSULTANT PSYCHIATRIST, Study chair, Jeddah Psychiatric hospital,Jeddah, Saudi ArabiaTarek Okasha, PROFESSOR, Study chair, Ain Shams University, Cairo, EgyptMohamed Nasr, PROFESSOR, Study chair, Cairo University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01544608
- Sponsor's protocol ID
- NIS-NME-XXX-2011/1
- Acronym
- RECONNECT-S
- Status last verified
- Jun 2013
- First submitted
- 20 Feb 2012
- Last updated
- 20 Jun 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non- Interventional Study to Observe Real Life Usage of Atypical Antipsychotics in the Acute Inpatient Management of Schizophrenia.
- ClinicalTrials.gov ID
- NCT01544608
- Acronym / sponsor ID
- RECONNECT-S / NIS-NME-XXX-2011/1
- Conditions
- Schizophrenia
- Keywords
- Acute psychotic episode of Schizophrenia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,076 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 6 Mar 2012 (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.
The primary objective of this Non- Interventional Study (NIS) is to describe the use of atypical antipsychotics in subjects with Schizophrenia during the hospitalisation due to acute psychotic episode by evaluation of drug, dose and mode of administration of the medication.
Detailed description
RECONNECT-S BETA
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects who are hospitalized due to acute psychotic episode. | – | –All subjects who are hospitalized due to acute psychotic episode. The subjects should be managed according to normal clinical practice until discharge time. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Psychiatric Institutes
Key inclusion criteria (3 listed)
- 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.
- Ability of the subject to understand and comply with the requirements of the study, as judged by the investigator.
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
Use of atypical antipsychotic(s) during hospitalisation.
Time frame: Hospitalisation period, an expected average of 3 weeks (variable per patient).
The data will be collected at one visit at the moment of discharge from the hospital.
Daily dosage of atypical antipsychotic(s) during hospitalisation.
Time frame: Hospitalisation period, an expected average of 3 weeks (variable per patient).
The data will be collected at one visit at the moment of discharge from the hospital.
Mode of administration of atypical antipsychotic(s) during hospitalisation.
Time frame: Hospitalisation period, an expected average of 3 weeks (variable per patient).
The data will be collected at one visit at the moment of discharge from the hospital.
6 secondary outcomes
Percent of patients with atypical antipsychotic as monotherapy.
Time frame: Hospitalisation period, an expected average of 3 weeks (variable per patient).
Percent of patients with combinations of antipsychotics.
Time frame: Hospitalisation period, an expected average of 3 weeks (variable per patient).
Main criteria of an antipsychotic's selection during hospitalisation expressed as percentage.
Time frame: Hospitalisation period, an expected average of 3 weeks (variable per patient).
Use of psychometric scales in day to day practice in therm of evaluation of the disease symptoms and thus efficacy of the treatment.
Time frame: Hospitalisation period, an expected average of 3 weeks (variable per patient).
Description of the usage of concomitant psychiatric medication (other than atypical antipsychotic) during the hospitalization.
Time frame: Hospitalisation period, an expected average of 3 weeks (variable per patient).
Relationship between medication used during the hospitalization and maintenance therapy recommended upon discharge.
Time frame: Hospitalisation period, an expected average of 3 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 20 Jun 2013.
Related trials for Schizophrenia
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 recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
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
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.
Talaat Matar, CONSULTANT PSYCHIATRIST study chair
Obaid Alla Hospital,Ras Al Khaima,UAE
Tarek Darwish, CONSULTANT PSYCHIATRIST study chair
Sheikh Khalifa Medical City(SKMC), Abudhabi,UAE
Sohail Khan, CONSULTANT PSYCHIATRIST study chair
Jeddah Psychiatric hospital,Jeddah, Saudi Arabia
7 sites in 3 countries: 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 7 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 20 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Saudi Arabia, United Arab Emirates, Egypt. 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?
Use of atypical antipsychotic(s) during hospitalisation. (time frame: Hospitalisation period, an expected average of 3 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 20 Jun 2013.