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

• ClinicalTrials.gov Identifier: NCT00660595
• Recruitment Status: Terminated
• First Posted: April 17, 2008
• Results First Posted: September 17, 2010
• Last Update Posted: September 17, 2010
• Sponsor: AstraZeneca
• Information provided by: AstraZeneca

Study Description

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 Design

• 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
• Actual Primary Completion Date: December 2008
• Actual Study Completion Date: December 2008

Arms and Interventions

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

Outcome Measures

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).

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older 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

Contacts and Locations

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

• Responsible Party: Hans Eriksson - Medical Science Director, AstraZeneca
• ClinicalTrials.gov Identifier: NCT00660595
• Other Study ID Numbers: D1443L00042
• First Posted: April 17, 2008
• 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; Antidepressive Agents