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

NCT ID: NCT00954122

Last Updated: 2013-01-08

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2010-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Schizophrenia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Quetiapine XR

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.

Group Type EXPERIMENTAL

Quetiapine XR (Seroquel XR)

Intervention Type DRUG

Tablet, oral, once daily

Interventions

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Quetiapine XR (Seroquel XR)

Tablet, oral, once daily

Intervention Type DRUG

Other Intervention Names

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Seroquel XR

Eligibility Criteria

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Inclusion Criteria

* Requirement for treatment of acute episode of schizophrenia (according to DSM-IV diagnostic criteria)
* PANSS total score of ³ 75
* CGI \> 4

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ahmad Hatim Sulaiman,, M Psyc

Role: PRINCIPAL_INVESTIGATOR

University of Malaya

Badiah Yahya, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Permai

Locations

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Research Site

Johor Bahru, Johor Bahru, Malaysia

Site Status

Research Site

Kuala Lumpur, , Malaysia

Site Status

Countries

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Malaysia

Other Identifiers

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D1443L00074

Identifier Type: -

Identifier Source: org_study_id

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