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SR-Registration Study 1, ROW: Efficacy and Safety of Seroquel® in the Treatment of Patients With Schizophrenia

AstraZeneca logo

AstraZeneca

Status and phase

Completed
Phase 3

Conditions

Schizophrenic Disorder

Treatments

Drug: Seroquel Immediate Release (IR)
Drug: Seroquel Sustained Release (SR)
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00206115
D1444C00132

Details and patient eligibility

About

The purpose of this 6-week study is to determine whether treatment with Seroquel® Sustained Release (SR) is more effective than placebo in the treatment of acute schizophrenia.

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

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • To be considered for this study the patients should be aged between 18 to 65 years, need to suffer from schizophrenia and must be willing to participate.

Exclusion criteria

  • Patients that suffer from psychiatric disorders other than schizophrenia including drug abuse and dependence, or medical conditions such as specific kidney, heart or thyroid problems, and patients with a known lack of response to drugs for schizophrenia will not be considered for this study.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

32

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Data sourced from clinicaltrials.gov

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