Schizophrenic Patients in Integrated Care

NCT00681629 | Terminated Phase 4 Results

• 1 other identifier: D1443L00048
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 8

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

Conditions

Schizophrenia; Schizoaffective Disorder; Schizophreniform Disorder

Keywords

Schizophrenia; Integrated Care; Quetiapine

Outcome Measures

Primary Outcomes (1)

• 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

  The SWN-K is comprised of 20 questions, each of which is rated using a 6 point scale ranging from 1 (not at all) to 6 (very much). Possible scores range from 20-120, with higher scores implying higher subjective well-being.

  4 months

Secondary Outcomes (19)

• Subjective Well-being Using the SWN-K (Subjective Well-being Under Neuroleptics Scale) Total Score

  4 month

• Symptomatic Outcome Using CGI-S (Clinical Global Impression-Schizophrenia) Scale

  4 month

• Symptomatic Outcome Using the PANSS-8 Scales(Positive and Negative Symptoms) Scale Score

  4 month

• GAF (Global Assessment of Functioning) Scale Score

  4 month

• PSP (Personal and Social Performance) Scale Score

  4 month

Study Arms (2)

Quetiapine XR Alone

EXPERIMENTAL

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

Quetiapine XR With Integrated Care Program (ICP)

EXPERIMENTAL

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; Other: Integrated Care Program (ICP)

Interventions

Quetiapine XR DRUG

400-800 mg, oral, bid

Also known as: Seroquel Prolong

Quetiapine XR Alone; Quetiapine XR With Integrated Care Program (ICP)

Integrated Care Program (ICP) 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.

Quetiapine XR With Integrated Care Program (ICP)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (8)

Research Site

München, Bavaria, Germany

Location

Research Site

Oranienburg, Brandenburg, Germany

Location

Research Site

Hamburg, Hamburg, Germany

Location

Research Site

Lüneburg, Lower Saxony, Germany

Location

Research Site

Oldenburg, Lower Saxony, Germany

Location

Research Site

Chemnitz, Saxony, Germany

Location

Research Site

Berlin, State of Berlin, Germany

Location

Research Site

Stolberg, Germany

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Limitations and Caveats

The study was stopped due to poor enrollment and no data analysis was performed.

Results Point of Contact

• Title: Gerard Lynch
• Organization: AstraZeneca

aztrial_results_posting@astrazeneca.com

Study Officials

• Martin Lambert, MD

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2008
• First Posted: May 21, 2008
• Study Start: July 1, 2008
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: July 30, 2012
• Results First Posted: July 30, 2012

Record last verified: 2012-06

Locations

DE (8)