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

AstraZeneca

Status and phase: Completed; Phase 4

Conditions: Schizophrenia

Treatments: Drug: Quetiapine XR (Seroquel XR)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00954122

D1443L00074

Details and patient eligibility

About

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.

Enrollment: 35 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

Quetiapine XR

Experimental group

Description:

Quetiapine XR 300 mg on day 1, 600 mg on day 2, and 400-800 mg (at investigator's discretion) on day 3 and onwards.

Treatment:

Drug: Quetiapine XR (Seroquel XR)