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Study in Schizophrenic In-patients Treated With Quetiapine Prolong or Oral Risperidone at Flexible Dose

NCT ID: NCT00660595

Last Updated: 2010-09-17

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

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2008-12-31

Brief Summary

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This pilot trial in Finland is designed to evaluate in a randomized fashion change of agitation in acute schizophrenic patients (Schizophrenia or Schizoaffective psychosis or Schizophreniformic psychosis)Diagnostic and Statistical Manual (DSM - IV) with the first visits on days 1, 2, 4 or 5 and 7 ± 1.

Detailed Description

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Conditions

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Schizophrenic Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Oral

Group Type EXPERIMENTAL

Quetiapine

Intervention Type DRUG

Oral administration

2

Oral

Group Type ACTIVE_COMPARATOR

Risperidone

Intervention Type DRUG

Oral administration

Interventions

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Quetiapine

Oral administration

Intervention Type DRUG

Risperidone

Oral administration

Intervention Type DRUG

Other Intervention Names

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Seroquel Risperdal

Eligibility Criteria

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Inclusion Criteria

* In the opinion of the Investigator, requirement for treatment for an acute episode of schizophrenia, schizoaffective disorder or schizophreniformic psychosis (according to DSM-IV diagnostic criteria), Positive and Negative Symptoms Scale (PANSS) ≥ 65, CGI ≥ 4

Exclusion Criteria

* Pregnancy or lactation
* In-patients/hospitalized \> 7 days before enrollment
* Known intolerance or lack of response to quetiapine fumarate or risperidone, as judged by the investigator
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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AstraZeneca

Principal Investigators

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Yrjö Ovaskainen, MD

Role: STUDY_DIRECTOR

AstraZeneca Finland

Hannu Koponen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Kuopio University

Locations

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Research Site

Harjavalta, , Finland

Site Status

Research Site

Helsinki, , Finland

Site Status

Research Site

Pitkäniemi, , Finland

Site Status

Research Site

Turku, , Finland

Site Status

Countries

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Finland

Other Identifiers

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D1443L00042

Identifier Type: -

Identifier Source: org_study_id