Clinical trial NCT00681629: Schizophrenic Patients in Integrated Care
Official title: CARE II - Evaluation of Treatment Outcomes in Schizophrenic Patients Taking Part in the Integrated Care Program - a Single-country, Multi-centre Phase IV Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Schizophrenia
Schizoaffective Disorder
Schizophreniform Disorder
Keywords: Schizophrenia
Integrated Care
Quetiapine
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-05-21
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to investigate the well-being of schizophrenic patients treated with quetiapine XR combined with participation in the integrated care program compared to a treatment with quetiapine XR alone over a period of 18 month


Eligibility criteria: Inclusion Criteria:

* Patients with baseline SWN-K \<=70
* Provision of signed informed consent
* Out-patients with schizophrenia, schizophreniform disorder or schizoaffective disorder, severe postpartum depressive disorders with psychotic symptoms and a minimum HAM-D cut off score of 20 points

Exclusion Criteria:

* Evidence of a clinical relevant disease, eg renal or hepatic impairment, significant coronary heart disease, hepatitis B or C, AIDS
* Patients with known cardiovascular disease or other condition predisposing to hypotension or family history of QT prolongation
* Patients who pose an imminent risk of suicide or danger to self or others

Primary outcomes:
measure: Subjective Well-being in Patients Treated for Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder, Delusional Disorder or Psychotic Disorder Not Otherwise Specified Using the SWN-K (Subjective Well-being Under Neuroleptics) Scale
timeFrame: 4 months
Secondary outcomes:
measure: Subjective Well-being Using the SWN-K (Subjective Well-being Under Neuroleptics Scale) Total Score
timeFrame: 4 month
measure: Symptomatic Outcome Using CGI-S (Clinical Global Impression-Schizophrenia) Scale
timeFrame: 4 month
measure: Symptomatic Outcome Using the PANSS-8 Scales(Positive and Negative Symptoms) Scale Score
timeFrame: 4 month
measure: GAF (Global Assessment of Functioning) Scale Score
timeFrame: 4 month
measure: PSP (Personal and Social Performance) Scale Score
timeFrame: 4 month
measure: EQ-5D (European Quality of Life Questionnaire) Score
timeFrame: 4 month
measure: Vocational Occupational Index "VOC" Score
timeFrame: Up to 18 months (V1 Day 1, V2 Month 1, V3 Month 3, V4 Month 6, V5 Month 12, V6 Month 18)
measure: Assess Quality of Life Levels Using the Q-LES-Q-18 (Quality of Life Enjoyment and Satisfaction) Questionnaire
timeFrame: 4 month
measure: Assess Quality of Life Levels Using the RSM Scale (Riedel-Spellmann-Musil) Scale
timeFrame: 4 month
measure: Assess Patient Engagement to Therapy Using the SES Scale (Service Engagement Scale)
timeFrame: 4 month
measure: Assess Compliance/Medication Adherence Using the MARS Scale (Medication Adherence Rating Scale)
timeFrame: 4 month
measure: Evaluate the Level of the Patients' (Subjective) Satisfaction Using the CSQ-8 Scale (Client Satisfaction Questionnaire)
timeFrame: 4 month
measure: Assess Health Economy Improvements in Terms of a Reduction in Treatment Costs and Loss of Productivity by Determination of the Total Cost by Number of Days With Hospitalization
timeFrame: 4 month
measure: Assess Health Economy Improvements in Terms of a Reduction in Treatment Costs and Loss of Productivity by Determination of the Total Number of Days the Patient Was Not Able to Work or go to School or Complete Routine Daily Activities
timeFrame: 4 month
measure: Assess Health Economy Improvements in Terms of a Reduction in Treatment Costs and Loss of Productivity by Determination of the Need for Any Additional Antipsychotic Medication
timeFrame: 4 month
measure: Evaluate Safety and Tolerability by Evaluation of Weight/Waist Circumference
timeFrame: 4 month
measure: Evaluate Safety and Tolerability by Evaluation of Laboratory Tests
timeFrame: 4 month
measure: Evaluate Safety and Tolerability by Evaluation of Concomitant Medication
timeFrame: 4 month
measure: Evaluate Safety and Tolerability by Evaluation of the Incidence of Adverse Events
timeFrame: 4 month
Other outcomes:
Locations:
city: Munchen
country: Germany
facility: Research Site
state: Bayern
city: Oranienburg
country: Germany
facility: Research Site
state: Brandenburg
city: Luneburg
country: Germany
facility: Research Site
state: Niedersachsen
city: Oldenburg
country: Germany
facility: Research Site
state: Niedersachsen
city: Chemnitz
country: Germany
facility: Research Site
state: Sachsen
city: Berlin
country: Germany
facility: Research Site
city: Hamburg
country: Germany
facility: Research Site
city: Stolberg
country: Germany
facility: Research Site
Study officials:
affiliation: Universitätsklinikum Hamburg-Eppendorf, Martinistr. 52, 20246 Hamburg, Germany
name: Martin Lambert, MD
role: PRINCIPAL_INVESTIGATOR
References: