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

Phase 3

Terminated

• Conditions: Schizophrenic Disorders
• Interventions: Drug: Quetiapine; Drug: Risperidone

• Registration Number: NCT00660595
• Lead Sponsor: AstraZeneca

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2008-04-14
• Study First Submitted QC: 2008-04-16
• Study First Posted: 2008-04-17
• Study Start: 2008-09
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Results First Submitted: 2009-12-04
• Status Verified: 2010-08
• Results First Submitted QC: 2010-08-24
• Last Update Submitted: 2010-08-24
• Results First Posted: 2010-09-17
• Last Update Posted: 2010-09-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 29

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Quetiapine	Oral
2	Risperidone	Oral

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Positive and Negative Symptoms Scale, Excitatory Subscale (PANSS-EC) Score (Time Frame: 3 Weeks)	baseline and 3 weeks	PANSS-EC score change was to be measured by calculating the difference between baseline score and 3 week's score. The PANSS-EC consists of 5 items (Poor IMpulse Control, Tension, Hostility, Uncooperativeness, and Excitement), each with associated descriptors. Each descriptor is rated on a 7 point scale from 1 = (absence of any symptom) to 7 = (extremely severe symptoms).

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Clinical Global Impression, Severity Scale (CGI-S) and in Absolute Clinical Global Impression, Improvement Scale (CGI-I) (Performed 4 Times/ 3 Weeks)	baseline and 3 weeks	The CGI change was to be measured by calculating the difference between baseline score and 3 week's score. CGI-S Score of 1 = no illness to score of 7 = extremely ill. CGI-I Score of 1 =very much improved since the initiation of treatment to 7=very much worse since the initiation of treatment
Change From Baseline in Overt Aggression Scale (OAS) (Performed 6 Times/ 3 Weeks)	baseline and 3 weeks	The Overt Agression Scale (OAS) change was to be measured by calculating the difference between baseline score and 3 week's score. Score between 1 and 16 verbal aggression (OAS 1, score 1-4), physical aggression against objects (OAS 2, score 5-8), physical aggression against self (OAS 3, score 9-11) and physical aggression against other people (OAS 4, score 12-16).
Change From Baseline in Total Positive and Negative Symptoms Scale (PANSS Score) (Performed 5 Times/ 3 Weeks)	baseline and 3 weeks	PANSS score change was to be measured by calculating the difference between baseline score and 3 week's score. The PANSS consists of 7 positive and 11 negative items each with associated descriptors. Each descriptor is rated on a 7 point scale from 1=(absence of any symptom) to 7=(extremely severe symptoms).

Trial Locations

Locations (1)

Research Site; 🇫🇮 Turku, Finland