NCT00617214

Brief Summary

Purpose of this non-interventional study (NIS) is to assess the effect of the participation in an integrated care program on treatment outcomes in patients treated with Seroquel for schizophrenia.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2008

Shorter than P25 for all trials

Geographic Reach
1 country

14 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

Study Start

First participant enrolled

January 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 5, 2008

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 15, 2008

Completed
10 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
Last Updated

December 10, 2010

Status Verified

October 1, 2008

Enrollment Period

11 months

First QC Date

February 5, 2008

Last Update Submit

December 8, 2010

Conditions

SchizophreniaSchizoaffective DisorderSchizophreni-form DisorderDelusional DisorderPsychotic Disorder Not Otherwise Specified

Keywords

SchizophreniaIntegrated care programSeroquel

Outcome Measures

Primary Outcomes (1)

  • Subjective Well-Being measured via SWN patient questionnaire

    6 month period of observation,4 assessments

Secondary Outcomes (3)

  • Quality of Life and patient's satisfaction measured by Q-LES-Q-18 and CSQ-8

    6 month period of observation, 1 assessment at end of NIS

  • Symptomatic and functional outcome measured by CGI-S, PANSS-8, GAF, EQ-5D and VOI

    6 month period of observation, 4 assesments

  • Compliance and health economic aspects measured by MARS, days of hospitalization, productivity loss

    6 month period of observation, 4 assesments

Study Arms (1)

All

Schizophrenic outpatients who are treated with Seroquel IR and who are additionally intended to start with an integrated care program

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

outpatient department from clinics or private practices

You may qualify if:

  • Outpatients suffering from schizophrenia, schizoaffective disorder, schizophreni-form disorder, delusional disorder or psychotic disorder not otherwise specified
  • Age 18 - 65 years
  • Current stable treatment with Seroquel according to SmPC since at least 2 months
  • Given consent to take part in an integrated care program prior to study startWritten informed consent to take part in this NIS

You may not qualify if:

  • Presence of any contraindication as described in the SmPC
  • Cancellation of participation in the integrated care program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Research Site

Ahrweiler, Germany

Location

Research Site

Berlin, Germany

Location

Research Site

Bonn, Germany

Location

Research Site

Hamburg, Germany

Location

Research Site

Mannheim, Germany

Location

Research Site

Mittweida, Germany

Location

Research Site

München, Germany

Location

Research Site

Münster, Germany

Location

Research Site

Oldenburg, Germany

Location

Research Site

Ottobrunn bei München, Germany

Location

Research Site

Spremberg, Germany

Location

Research Site

Stolberg, Germany

Location

Research Site

Werneck, Germany

Location

Research Site

Zittau, Germany

Location

MeSH Terms

Conditions

SchizophreniaPsychotic DisordersSchizophrenia, Paranoid

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Sandra Liedtke, MD

    AstraZeneca

    STUDY DIRECTOR

  • Martin Lambert, PD, MD

    University of Hamberg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 5, 2008

First Posted

February 15, 2008

Study Start

January 1, 2008

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

December 10, 2010

Record last verified: 2008-10

Locations

DE(14)