Schizophrenic patients in Integrated Care - CARE II

Study identifier:D1443L00048

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Terminated/Withdrawn

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

Medical condition

schizophrenia

Phase

Phase 4

Healthy volunteers

Study drug

Quetiapine XR

Sex

All

Actual Enrollment

Study type

Interventional

Age

18 Years - 65 Years

Date

Study Start Date: 01 Jul 2008

Primary Completion Date: 01 Nov 2008

Study Completion Date: 01 Nov 2008

Study design

Allocation: Non-randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Jun 2012 by AstraZeneca Pharmaceuticals

Collaborators

Inclusion and exclusion criteria

No locations available

Arms	Assigned Interventions
Experimental: Quetiapine XR Alone Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion	Drug: Quetiapine XR 400-800 mg, oral, bid Other Name: Seroquel Prolong
Experimental: Quetiapine XR With Integrated Care Program (ICP) Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion	Drug: Quetiapine XR 400-800 mg, oral, bid Other Name: Seroquel Prolong Other: Integrated Care Program (ICP) Integrated care program (ICP), this is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance.

Arms

Assigned Interventions

Experimental: Quetiapine XR Alone
Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion

Drug: Quetiapine XR
400-800 mg, oral, bid

Other Name: Seroquel Prolong

Experimental: Quetiapine XR With Integrated Care Program (ICP)
Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion

Drug: Quetiapine XR
400-800 mg, oral, bid

Other Name: Seroquel Prolong

Other: Integrated Care Program (ICP)
Integrated care program (ICP), this is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance.

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=266&filename=CSR-D1443L00048.pdf
Download
CSR-D1443L00048.pdf
Download
Trial Results Summaries
Available here

Contacts

Contact

acromion Frechen

+49 (0) 2234-20 37 37 -0

Investigators

Principal Investigator

Martin Lambert

Universitätsklinikum Hamburg-Eppendorf, Martinistr. 52, 20246 Hamburg, Germany