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

This study has been terminated.
(To difficult to recruit patients in the acute setting)
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00660595
First received: April 14, 2008
Last updated: August 24, 2010
Last verified: August 2010
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 19, 2014