Schizophrenic Patients Taking Part in Integrated Care Program

Evaluation of Treatment Outcomes in Schizophrenic Patients Taking Part in the Integrated Care Program - a Single-country, Multi-centre Non-interventional Study

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00617214

Acronym

CARE I

Enrollment

Registered

2008-02-15

Start date

2008-01-31

Completion date

2008-12-31

Last updated

2010-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delusional Disorder, Psychotic Disorder Not Otherwise Specified, Schizoaffective Disorder, Schizophrenia, Schizophreni-form Disorder

Keywords

Schizophrenia, Integrated care program, Seroquel

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Subjective Well-Being measured via SWN patient questionnaire	6 month period of observation,4 assessments

Secondary

Measure	Time frame
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

Countries

Germany

Outcome results