Schizophrenic Patients in Integrated Care (CARE II)

This study has been terminated.
(Difficulty finding eligible sites/patients; current situation in health policy cause negative effect on existing/planned contracts for integrated care program)
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00681629
First received: May 20, 2008
Last updated: June 22, 2012
Last verified: June 2012
Results First Received: April 7, 2010  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Schizophrenia
Schizoaffective Disorder
Schizophreniform Disorder
Interventions: Drug: Quetiapine XR
Other: Integrated Care Program (ICP)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Study period July 2008 to November 2008; Centre Dr. Lambert (Hamburg), Centre Dr. Dorn (Berlin)

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

Integrated Care Program (ICP) 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 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

Participant Flow:   Overall Study
    Quetiapine XR With Integrated Care Program (ICP)     Quetiapine XR Alone  
STARTED     5 [1]   2 [1]
COMPLETED     0     0  
NOT COMPLETED     5     2  
Study termination                 4                 2  
Adverse Event                 1                 0  
[1] It was planned to recruit 100 patient



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

Integrated Care Program (ICP) 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 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
Total Total of all reporting groups

Baseline Measures
    Quetiapine XR With Integrated Care Program (ICP)     Quetiapine XR Alone     Total  
Number of Participants  
[units: participants]
  5     2     7  
Age, Customized  
[units: Participants]
     
18-65 years     5     2     7  
Gender  
[units: Participants]
     
Female     5     0     5  
Male     0     2     2  



  Outcome Measures
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1.  Primary:   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   [ Time Frame: 4 months ]

2.  Secondary:   Subjective Well-being Using the SWN-K (Subjective Well-being Under Neuroleptics Scale) Total Score   [ Time Frame: 4 month ]

3.  Secondary:   Symptomatic Outcome Using CGI-S (Clinical Global Impression-Schizophrenia) Scale   [ Time Frame: 4 month ]

4.  Secondary:   Symptomatic Outcome Using the PANSS-8 Scales(Positive and Negative Symptoms) Scale Score   [ Time Frame: 4 month ]

5.  Secondary:   GAF (Global Assessment of Functioning) Scale Score   [ Time Frame: 4 month ]

6.  Secondary:   PSP (Personal and Social Performance) Scale Score   [ Time Frame: 4 month ]

7.  Secondary:   EQ-5D (European Quality of Life Questionnaire) Score   [ Time Frame: 4 month ]

8.  Secondary:   Vocational Occupational Index "VOC" Score   [ Time Frame: Up to 18 months (V1 Day 1, V2 Month 1, V3 Month 3, V4 Month 6, V5 Month 12, V6 Month 18) ]

9.  Secondary:   Assess Quality of Life Levels Using the Q-LES-Q-18 (Quality of Life Enjoyment and Satisfaction) Questionnaire   [ Time Frame: 4 month ]

10.  Secondary:   Assess Quality of Life Levels Using the RSM Scale (Riedel-Spellmann-Musil) Scale   [ Time Frame: 4 month ]

11.  Secondary:   Assess Patient Engagement to Therapy Using the SES Scale (Service Engagement Scale)   [ Time Frame: 4 month ]

12.  Secondary:   Assess Compliance/Medication Adherence Using the MARS Scale (Medication Adherence Rating Scale)   [ Time Frame: 4 month ]

13.  Secondary:   Evaluate the Level of the Patients' (Subjective) Satisfaction Using the CSQ-8 Scale (Client Satisfaction Questionnaire)   [ Time Frame: 4 month ]

14.  Secondary:   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   [ Time Frame: 4 month ]

15.  Secondary:   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   [ Time Frame: 4 month ]

16.  Secondary:   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   [ Time Frame: 4 month ]

17.  Secondary:   Evaluate Safety and Tolerability by Evaluation of Weight/Waist Circumference   [ Time Frame: 4 month ]

18.  Secondary:   Evaluate Safety and Tolerability by Evaluation of Laboratory Tests   [ Time Frame: 4 month ]

19.  Secondary:   Evaluate Safety and Tolerability by Evaluation of Concomitant Medication   [ Time Frame: 4 month ]

20.  Secondary:   Evaluate Safety and Tolerability by Evaluation of the Incidence of Adverse Events   [ Time Frame: 4 month ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The study was stopped due to poor enrollment and no data analysis was performed.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Gerard Lynch
Organization: AstraZeneca
e-mail: aztrial_results_posting@astrazeneca.com


No publications provided


Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00681629     History of Changes
Other Study ID Numbers: D1443L00048
Study First Received: May 20, 2008
Results First Received: April 7, 2010
Last Updated: June 22, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices