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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

All eligible patients receiving Quetiapine XR for the first time in the inclusion period regardless the diagnosed disease or the patients’ age.
Patients aged 18 years and over and diagnosed with bipolar disorder or schizophrenia according to DSM-IV criteria will be followed during 12 months.

Patients would have to be prescribed for the first time with a new (not used during the preceding 3 months) atypical antipsychotic other than Quetiapine XR (irrespective this new atypical antipsychotic is preceded or not by another atypical antipsychotic).

Patients would have to be prescribed a new (not used during the preceding 3 months) antidepressant [N06A], antipsychotic (other than Quetiapine XR) [N05A] or mood stabilizer (including lithium [N05AN], valproate [N03AG01], and lamotrigine [N03AX09].

The aim of the study is to describe patient characteristics (demographic and clinical) and the patterns of use of Quetiapine XR in patients receiving the drug for the first time in real-life practice regardless the final diagnosis.

Description of the use of Quetiapine Extended Release (XR) in real-life practice in France. An observational study

Description of the use of Quetiapine Extended Release (XR) in real-life practice in France

NCT ID

Therapeutic Area

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Reserach Site

Research SIte

research Site

Variables related with how the drug is prescribed and used by the patient [doses in mg/day, titration (yes/no), time of administration (morning/middle of the day/afternoon/evening), concomitant treatments] are going to be described.

Age, gender, educational and professional status, co-habitation are going to be described.

Diagnosis, family history of psychiatric disorders, number of suicidal attempts within the last 12 months, co-morbidities, treatments received during the last 12 months, laboratory and exam data will be included in the description.

The Clinical Global Impressions Scale - Severity (CGI-S) assesses the clinician’s impression of the current state of the patient’s illness.
The following scores can be given: 1=normal, not at all ill, 2=borderline mentally ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, and 7=among the most extremely ill patients.

New psychiatric hospitalisation, deterioration of the CGI-S (Clinical Global Impressions Scale - Severity) by at least 3 points for a baseline score of 1, at least 2 points for a baseline score of 2 or 3, at least 1 point for a baseline score of 4.

Arms	Assigned Interventions
Main study population All eligible patients receiving Quetiapine XR for the first time in the inclusion period regardless the diagnosed disease or the patients’ age. Patients aged 18 years and over and diagnosed with bipolar disorder or schizophrenia according to DSM-IV criteria will be followed during 12 months.	-
Schizophrenia SoC sample Patients would have to be prescribed for the first time with a new (not used during the preceding 3 months) atypical antipsychotic other than Quetiapine XR (irrespective this new atypical antipsychotic is preceded or not by another atypical antipsychotic).	-
Bipolar SoC sample Patients would have to be prescribed a new (not used during the preceding 3 months) antidepressant [N06A], antipsychotic (other than Quetiapine XR) [N05A] or mood stabilizer (including lithium [N05AN], valproate [N03AG01], and lamotrigine [N03AX09].	-

Description of the use of Quetiapine Extended Release (XR) in real-life practice in France. An observational study - TBD

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Documents available

NIS-NFR-SER-2012/1 SUMMARY SYNOPSIS

Trial Results Summaries

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Contact

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Principal Investigator