NCT00660595

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2008

Shorter than P25 for phase_3

Geographic Reach
1 country

4 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 14, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 17, 2008

Completed
5 months until next milestone

Study Start

First participant enrolled

September 1, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

September 17, 2010

Completed
Last Updated

September 17, 2010

Status Verified

August 1, 2010

Enrollment Period

3 months

First QC Date

April 14, 2008

Results QC Date

December 4, 2009

Last Update Submit

August 24, 2010

Conditions

Schizophrenic Disorders

Keywords

SchizophreniaSchizoaffective psychosisSchizophreniformic psychosisPilot studyQuetiapine ProlongRisperidone

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in Positive and Negative Symptoms Scale, Excitatory Subscale (PANSS-EC) Score (Time Frame: 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 Outcomes (3)

  • 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)

    baseline and 3 weeks

  • Change From Baseline in Overt Aggression Scale (OAS) (Performed 6 Times/ 3 Weeks)

    baseline and 3 weeks

  • Change From Baseline in Total Positive and Negative Symptoms Scale (PANSS Score) (Performed 5 Times/ 3 Weeks)

    baseline and 3 weeks

Study Arms (2)

1

EXPERIMENTAL

Oral

Drug: Quetiapine

2

ACTIVE COMPARATOR

Oral

Drug: Risperidone

Interventions

QuetiapineDRUG

Oral administration

Also known as: Seroquel
1
RisperidoneDRUG

Oral administration

Also known as: Risperdal
2

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Research Site

Harjavalta, Finland

Location

Research Site

Helsinki, Finland

Location

Research Site

Pitkäniemi, Finland

Location

Research Site

Turku, Finland

Location

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Interventions

Quetiapine FumarateRisperidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

DibenzothiazepinesThiazepinesThiepinsSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-Ring

Results Point of Contact

Title
Gerard Lynch
Organization
AstraZeneca
aztrial_results_posting@astrazeneca.com

Study Officials

  • Yrjö Ovaskainen, MD

    AstraZeneca Finland

    STUDY DIRECTOR

  • Hannu Koponen, MD, PhD

    Kuopio University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 14, 2008

First Posted

April 17, 2008

Study Start

September 1, 2008

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

September 17, 2010

Results First Posted

September 17, 2010

Record last verified: 2010-08

Locations

FI(4)