Schizophrenic Patients in Integrated Care (CARE II)

AstraZeneca

Status and phase: Terminated; Phase 4

Conditions: Schizophreniform Disorder; Schizophrenia; Schizoaffective Disorder

Treatments: Drug: Quetiapine XR; Other: Integrated Care Program (ICP)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00681629

D1443L00048

Details and patient eligibility

About

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

Enrollment: 7 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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7 participants in 2 patient groups

Quetiapine XR Alone

Experimental group

Description:

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

Treatment:

Drug: Quetiapine XR

Quetiapine XR With Integrated Care Program (ICP)

Experimental group

Description:

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

Treatment:

Other: Integrated Care Program (ICP)

Drug: Quetiapine XR