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

Purpose

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.

Condition	Intervention	Phase
Schizophrenic Disorders	Drug: Quetiapine Drug: Risperidone	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Pilot Study of Three-Week, Randomised, Open Comparison in Schizophrenic In-patients Treated With Quetiapine Prolong or Oral Risperidone at Flexible Dose

Resource links provided by NLM:

MedlinePlus related topics: Mental Disorders Psychotic Disorders Schizophrenia

Drug Information available for: Risperidone Quetiapine Quetiapine fumarate

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Change From Baseline in Positive and Negative Symptoms Scale, Excitatory Subscale (PANSS-EC) Score (Time Frame: 3 Weeks) [ Time Frame: baseline and 3 weeks ] [ Designated as safety issue: No ]
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:

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) [ Time Frame: baseline and 3 weeks ] [ Designated as safety issue: No ]
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) [ Time Frame: baseline and 3 weeks ] [ Designated as safety issue: No ]
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) [ Time Frame: baseline and 3 weeks ] [ Designated as safety issue: No ]
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).

Enrollment:	29
Study Start Date:	September 2008
Study Completion Date:	December 2008
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Oral	Drug: Quetiapine Oral administration Other Name: Seroquel
Active Comparator: 2 Oral	Drug: Risperidone Oral administration Other Name: Risperdal

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00660595

Locations

Finland
Research Site
Harjavalta, Finland
Research Site
Helsinki, Finland
Research Site
Pitkaniemi, Finland
Research Site
Turku, Finland

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	Yrjö Ovaskainen, MD	AstraZeneca Finland
Principal Investigator:	Hannu Koponen, MD, PhD	Kuopio University

More Information

No publications provided

Responsible Party:	Hans Eriksson - Medical Science Director, AstraZeneca
ClinicalTrials.gov Identifier:	NCT00660595 History of Changes
Other Study ID Numbers:	D1443L00042
Study First Received:	April 14, 2008
Results First Received:	December 4, 2009
Last Updated:	August 24, 2010
Health Authority:	Finland: Finnish Medicines Agency

Keywords provided by AstraZeneca:

Schizophrenia
Schizoaffective psychosis
Schizophreniformic psychosis

Pilot study
Quetiapine Prolong
Risperidone

Additional relevant MeSH terms:

Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Risperidone
Quetiapine
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on June 18, 2013