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

AstraZeneca

Status and phase: Terminated; Phase 3

Conditions: Schizophrenic Disorders

Treatments: Drug: Risperidone; Drug: Quetiapine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00660595

D1443L00042

Details and patient eligibility

About

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.

Enrollment: 29 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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29 participants in 2 patient groups

1

Experimental group

Description:

Oral

Treatment:

Drug: Quetiapine

2

Active Comparator group

Description:

Oral

Treatment:

Drug: Risperidone