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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

This is an 8-week, multi-centre, Open-label, non-comparative study to evaluate the efficacy and safety of Quetiapine XR with daily dose 400mg-800mg used as mono-therapy in the treatment of acute schizophrenic patients. The eligible patient will be assigned to study treatment with Quetiapine XR on Day 1. 

PLEASE NOTE:  Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.

Study of the Efficacy and Safety of Quetiapine Fumarate Extended Release (Seroquel XR)

Research site

A 8-week, Multi-Centre, Open-label, Non-comparative, Phase IV Study of the Efficacy and Safety of Quetiapine Fumarate Extended Release (Seroquel XR) with daily dose 400mg-800mg in the Treatment of Acute Schizophrenic Patients

PANSS, a 30-item scale where each symptom is rated on a severity scale ranging from 1 (absent) - 7 (extreme), total score is 30 – 210.
Description of the reporting Groups: Evaluate the efficacy of Quetiapine XR with daily dose 400 mg - 800 mg used as mono-therapy in the treatment of acute schizophrenic patients by evaluation of the change from baseline to Day 57 in total score of PANSS using the last observation carried forward (LOCF) method

Age Continuous

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Study Specific Characteristic

The MITT set was used for primary analyses (89) participants

The change in Positive and Negative Syndrome Scale(PANSS)Total Score

To evaluate the change of positive symptoms from baseline to Day 57 in PANSS positive score, a 7-item scale where eash symptom is rated on a severity scale ranging from 1 (absent) - 7 (extreme)

Positive and Negative Syndrome Scale (PANSS) positive score

To evaluate the change of negative symptoms from baseline to Day 57 in PANSS negative score, a 7-item scale where each symptom is rated on a severity scale ranging from 1 (absent) - 7 (extreme)

Positive and Negative Syndrome Scale (PANSS) negative score

To evaluate the change of general psychopathology symptoms from baseline to Day 57 in PANSS general score, a 16-item scale where each symptom is rated on a severity scale ranging from 1 (absent) to - 7 (extreme)

Positive and Negative Syndrome Scale (PANSS) general psychopathology score

The Clinical Global Impression – Severity (CGI-S) and – illness (CGI-I) is used in this study. The CGI-S is scored to rate the patient’s current clinical state. The CGI-I is scored to rate the patient’s change from baseline CGI. Each CGI item is scored on a scale from 1 to 7 (CGI-S: 1 = Normal, not ill, 7= Among the most extremely ill patients/ CGI-I: 1= very much improved, 7= very much worse). CGI-I scores greater than 4 indicate worsening, while scores less than 4 indicate improvement

Clinical Global Impression (CGI) score

To treat depressive symptoms in acute schizophrenic patients by evaluation of the change from baseline to day 67 in MADRS total score, a 10-item scale for the evaluation of depressive symptoms.  Each MADRS item is rated on a 0-6 scale, higher MADRS scores indicate higher levels of depressive symptoms.

Montgomery-Asberg Depression Rating Scale (MADRS) total score

To improve functional capability in acute schizophrenic patients by evaluation of the change from baseline to Day 57 in GAF scale score, a single-item rating scale for evaluating the overall functioning on a continuum from psychologic or psychiatric sickness to health.

Study of the Efficacy and Safety of Quetiapine Fumarate Extended Release (Seroquel XR) - QUENCH

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Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=270&filename=CSR-D1443L00062.pdf

CSR-D1443L00062.pdf

Trial Results Summaries

Contacts

Contact

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Principal Investigator