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Schizophrenic Patients in Integrated Care

NCT ID: NCT00681629

Last Updated: 2012-07-30

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2008-11-30

Brief Summary

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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

Detailed Description

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Conditions

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Schizophrenia Schizoaffective Disorder Schizophreniform Disorder

Keywords

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Schizophrenia Integrated Care Quetiapine

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Quetiapine XR

Intervention Type DRUG

400-800 mg, oral, bid

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

Group Type EXPERIMENTAL

Quetiapine XR

Intervention Type DRUG

400-800 mg, oral, bid

Integrated Care Program (ICP)

Intervention Type OTHER

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.

Interventions

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Quetiapine XR

400-800 mg, oral, bid

Intervention Type DRUG

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.

Intervention Type OTHER

Other Intervention Names

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Seroquel Prolong

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Martin Lambert, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Research Site

München, Bavaria, Germany

Site Status

Research Site

Oranienburg, Brandenburg, Germany

Site Status

Research Site

Hamburg, City state of Hamburg, Germany

Site Status

Research Site

Lüneburg, Lower Saxony, Germany

Site Status

Research Site

Oldenburg, Lower Saxony, Germany

Site Status

Research Site

Chemnitz, Saxony, Germany

Site Status

Research Site

Berlin, State of Berlin, Germany

Site Status

Research Site

Stolberg, , Germany

Site Status

Countries

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Germany

Other Identifiers

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D1443L00048

Identifier Type: -

Identifier Source: org_study_id