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Efficacy and Safety of SEROQUEL Extended Release (XR) in Acute Schizophrenia

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Schizophrenia

Intervention: Quetiapine XR (Seroquel XR) (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Ahmad Hatim Sulaiman,, M Psyc, Principal Investigator, Affiliation: University Malaya Medical Centre
Badiah Yahya, MD, Principal Investigator, Affiliation: Hospital Permai


The purpose of the study is to determine whether treatment with quetiapine XR (Seroquel XR) tablets for 3 weeks will improve their agitation when they have acute psychosis.

Clinical Details

Official title: A 3 Weeks Open Label Study to Evaluate the Efficacy in Agitation and Safety of Quetiapine Fumarate XR in Treatment of Patients With Acute Schizophrenia

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Change From Baseline in Positive and Negative Syndrome Scale Excited Component (PANSS-EC) Score

Secondary outcome:

Change From Baseline to Final Visit at Day 21 in PANSS Positive, General Psychopathological Scores.

Change From Baseline to Final Visit at Day 21 in PANSS Negative, General Psychopathological Scores

Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score

Change From Baseline in Clinical Global Impression-Severity Scale (CGI-S)

Change From Baseline in Absolute Clinical Global Impression-Improvement (CGI-I) Scale

Change of the Positive and Negative Syndrome Scale Excited Component (PANSS-EC) Score Compared From Baseline to Day 21.


Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.


Inclusion Criteria:

- Requirement for treatment of acute episode of schizophrenia (according to DSM-IV

diagnostic criteria)

- PANSS total score of ³ 75

- CGI > 4

Exclusion Criteria:

- Any DSM-IV (Diagnostic and Statistical Manual of Mental Disorders 4th Edition) Axis I

disorder not defined in the inclusion criteria

- Patients who, in the opinion of the investigator, pose an imminent risk of suicide or

a danger to self or others

- Substance or alcohol dependence at enrollment

Locations and Contacts

Research Site, Kuala Lumpur, Malaysia

Research Site, Johor, Johor Bahru, Malaysia

Additional Information

Starting date: September 2009
Last updated: January 7, 2013

Page last updated: August 23, 2015

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