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

August 24, 2010 updated by: AstraZeneca

A Pilot Study of Three-Week, Randomised, Open Comparison in Schizophrenic In-patients Treated With Quetiapine Prolong or Oral Risperidone at Flexible Dose

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Oral
Drug: Quetiapine
Oral administration
Other Names:
  • Seroquel
ACTIVE_COMPARATOR: 2
Oral
Drug: Risperidone
Oral administration
Other Names:
  • Risperdal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Positive and Negative Symptoms Scale, Excitatory Subscale (PANSS-EC) Score (Time Frame: 3 Weeks)
Time Frame: 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).
baseline and 3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
baseline and 3 weeks
Change From Baseline in Overt Aggression Scale (OAS) (Performed 6 Times/ 3 Weeks)
Time Frame: 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).
baseline and 3 weeks
Change From Baseline in Total Positive and Negative Symptoms Scale (PANSS Score) (Performed 5 Times/ 3 Weeks)
Time Frame: 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).
baseline and 3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (ACTUAL)

December 1, 2008

Study Completion (ACTUAL)

December 1, 2008

Study Registration Dates

First Submitted

April 14, 2008

First Submitted That Met QC Criteria

April 16, 2008

First Posted (ESTIMATE)

April 17, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

September 17, 2010

Last Update Submitted That Met QC Criteria

August 24, 2010

Last Verified

August 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D1443L00042

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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