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

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ClinicalTrials.gov Identifier: NCT00660595
Recruitment Status : Terminated (To difficult to recruit patients in the acute setting)
First Posted : April 17, 2008
Results First Posted : September 17, 2010
Last Update Posted : September 17, 2010
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Schizophrenic Disorders Drug: Quetiapine Drug: Risperidone Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : September 2008
Primary Completion Date : December 2008
Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Oral
Drug: Quetiapine
Oral administration
Other Name: Seroquel
Active Comparator: 2
Oral
Drug: Risperidone
Oral administration
Other Name: Risperdal



Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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

  2. 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).

  3. 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).



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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Hans Eriksson - Medical Science Director, AstraZeneca
ClinicalTrials.gov Identifier: NCT00660595     History of Changes
Other Study ID Numbers: D1443L00042
First Posted: April 17, 2008    Key Record Dates
Results First Posted: September 17, 2010
Last Update Posted: September 17, 2010
Last Verified: August 2010

Keywords provided by AstraZeneca:
Schizophrenia
Schizoaffective psychosis
Schizophreniformic psychosis
Pilot study
Quetiapine Prolong
Risperidone

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Risperidone
Quetiapine Fumarate
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents