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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

The purpose of this study is to evaluate the efficacy of Seroquel XR in schizophrenia patients with acute worsening symptoms. Consequently, to assess whether the study drug is safe and acceptable on the daily dose basis, orally given, up to 600 mg once a day for 42 days.

Seroquel XR in adults with schizophrenia

600mg Extended release tablet, oral, once daily

Research Site

Open-label multicentre study on efficacy and safety of oral quetiapine (Seroquel XR) in adults with schizophrenia

Change in Positive and Negative Syndrome Scale Total Score from Day 1 (baseline) to Day 42 (final visit) or withdrawal. Minimum value of total PANSS is 30 , Maximum is 210. 

Minimum value considered better is score decreased from baseline at least 30%.

Age Continuous

Gender, Male/Female

Day 1 (Baseline) (n= 28)

Day 42 (n= 17)

Clinical Global Impression - Severity of Illness. Maximum possible value is 7 (worst outcome), the minimum is 1 (best outcome). Values are considered better outcome: decrease from baseline > 1 score.

The number of patient at Day 42 (n= 17) is different than at Baseline (n= 28), because some of them withdraw/terminate during the study.

Change in Clinical Global Impression - Severity of Illness (CGI-S) score

Change in positive and Negative Syndrome Scale (PANSS) total score

The number of patient is different, because some of them withdraw/terminate during the study.

Clinical Global Impression - Severity of Illness (CGI-S) score

Overall Study

On Day 1, baseline assessments will be performed, and patients will be assigned to Seroquel XR at 300 mg. On Day 2 all patients are assigned to reach target dose of Seroquel XR at 600 mg. Administration of study medication continue with Seroquel XR 600 mg daily until Day 42. Each visit will have ± 3 days window period.

Seroquel XR in adults with schizophrenia

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=269&filename=CSR-D1443L00060.pdf

CSR-D1443L00060.pdf

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator