Schizophrenic Patients in Integrated Care

Schizophrenia Clinical Trial

— CARE II  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00681629
• Other study ID #: D1443L00048
• Status: Terminated
• Phase: Phase 4
• First received: May 20, 2008
• Last updated: June 22, 2012
• Start date: July 2008
• Est. completion date: November 2008

Study information

• Verified date: June 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Disease
• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia
• Schizophreniform Disorder

Intervention

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

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.

Locations

Country	Name	City	State
Germany	Research Site	Berlin
Germany	Research Site	Chemnitz	Sachsen
Germany	Research Site	Hamburg
Germany	Research Site	Luneburg	Niedersachsen
Germany	Research Site	Munchen	Bayern
Germany	Research Site	Oldenburg	Niedersachsen
Germany	Research Site	Oranienburg	Brandenburg
Germany	Research Site	Stolberg

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	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	No
Secondary	Subjective Well-being Using the SWN-K (Subjective Well-being Under Neuroleptics Scale) Total Score	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 month	No
Secondary	Symptomatic Outcome Using CGI-S (Clinical Global Impression-Schizophrenia) Scale	With the CGI-S the rate of the severity of a patient's symptoms (positive, negative, cognitive, depressive and overall) using a scale ranging from 1 (normal, not ill) to 7 (among the most severely ill) is measured - higher scores implying higher severity.	4 month	No
Secondary	Symptomatic Outcome Using the PANSS-8 Scales(Positive and Negative Symptoms) Scale Score	The schizophrenic symptomatology will be measured by the Positive and Negative Syndrome Scale (PANSS) providing 8 items of which each is rated on a severity scale ranging from 1-7, (1= absent - 7 = extreme severe. higher scores implying higher severity.	4 month	No
Secondary	GAF (Global Assessment of Functioning) Scale Score	The "GAF" is a numeric rating scale used by clinicians for assessment of the social, occupational, psychological functioning of adult patients. The scale represents a hypothetical continuum of mental health illness providing a descending scoring code from 100 until 0. Higher scores indicate better patient condition and performance.	4 month	No
Secondary	PSP (Personal and Social Performance) Scale Score	The '(PSP" rating scale (100 until 0) used by clinicians for assessment of 4 main domains of functioning in adult patients acc. (a) socially useful activities including work and study, (b) personal and social relationships, (c) self-care, and (d) disturbing and aggressive behavior. Higher scores indicate better patient condition and performance.	4 month	No
Secondary	EQ-5D (European Quality of Life Questionnaire) Score	The EQ-5D questionnaire is a generic measure of health status. It defines health in terms of five dimensions:1 (Mobility); 2 (Self-care); 3 (Usual activity); 4 (Pain/Discomfort); 5 (Anxiety/Depression).; The minimum possible value is 5 (one point for each dimension) and the maximum possible values is 15 (3 points for each dimension). Each dimension has 3 levels of "severity"- "no problems, "some problems" and "extreme problems". Higher scores indicate more problems.	4 month	No
Secondary	Vocational Occupational Index "VOC" Score	The "VOC" index will assess the following 7 items: 1 fulltime gainful employment, 2 homemaker or student, 3 part-time gainful employment (20 hours per week or less), 4 retired, 5 full or part-time volunteer, 6 on medical or psychiatric leave of absence, 7 unemployed, whether or not expected to work. Results will be descriptively summarized. The VOC index will be completed at each visit. Difference from baseline of the index will be derived at each assessment	Up to 18 months (V1 Day 1, V2 Month 1, V3 Month 3, V4 Month 6, V5 Month 12, V6 Month 18)	No
Secondary	Assess Quality of Life Levels Using the Q-LES-Q-18 (Quality of Life Enjoyment and Satisfaction) Questionnaire	Q-LES-Q-18 will allow to generate a general QoL-index which will be used for the analysis and is defined as the average of the single scores for all 18 items. Scoring will be carried out from 1-5 per item (never / rarely / sometimes / frequently / all the time). Results will be descriptively summarized.	4 month	No
Secondary	Assess Quality of Life Levels Using the RSM Scale (Riedel-Spellmann-Musil) Scale	The '(RSM" is a new 36-item measure validated to assess the "QoL" in different dimensions of schizophrenic patient treated with antipsychotics. It will be rated on a four-point Likert scale (not / rather not / rather yes / yes) by the patient and the investigator. The total score ranges from min. 0 to max. of 108. Higher scores indicate higher "QoL".	4 month	No
Secondary	Assess Patient Engagement to Therapy Using the SES Scale (Service Engagement Scale)	The 'SES" is a 14-item measure consisting of statements that assess the client specific engagement with services. It will be rated on a four-point Likert scale (not at all / rarely / sometimes / most of the time) by the investigator. The total score ranges from min. 0 to a max. of 42. Higher scores indicate lower engagement.	4 month	No
Secondary	Assess Compliance/Medication Adherence Using the MARS Scale (Medication Adherence Rating Scale)	The 'Medication Adherence Rating Scale' (MARS) is a reliable and valid self-reporting tool for investigation of the compliance in psychiatric patients also recognizing the complexity of compliance behaviour. 10 questions on medication attitude have to be answered by 'yes' or 'no' (8 times 1= no and Yes = 0 and twice 1= no, Yes =1). Results will be descriptively summarized. Summarized results minimum 0: low medication adherence, maximum 10: high medication adherence.	4 month	No
Secondary	Evaluate the Level of the Patients' (Subjective) Satisfaction Using the CSQ-8 Scale (Client Satisfaction Questionnaire)	The 'CSQ-8" is a brief, self-administered method to monitor the consumer's satisfaction with services in outpatient psychotherapy, showing high internal consistency. It is identified as a core subset of the general CSQ covering 8 Likert-type items with four response choices where '1' indicates the lowest and '4' the highest degree of satisfaction.	4 month	No
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	Any hospitalisation days in inpatients units and emergency ward stays will be recorded. At each hospitalisation, the number of days will be computed and at each visit, the cumulative total number of days will be used to calculate total costs. As higher the number of hospitalisation days as higher the costs per patient.	4 month	No
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	The number of lost work days, lost school days or days without completing routine daily activities will be evaluated. With any number of lost workdays or lost school days or without completing routine daily activities, the costs will increase and the productivity will decrease.	4 month	No
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	Concomitant psychotropic drugs will be coded (ATC = Drug code) to allow a comparison of the number of drugs used per ATC class and per treatment visit. The drugs used will be listed by keeping their brand name for allowing to translate them into costs.	4 month	No
Secondary	Evaluate Safety and Tolerability by Evaluation of Weight/Waist Circumference	Measuring of weight and waist circumference in centimeter.	4 month	No
Secondary	Evaluate Safety and Tolerability by Evaluation of Laboratory Tests	Measuring of: B-Haemoglobin (g/dl), B-Haematocrit(%), B-Erythrocyte count(pl), B-Leucocytes count (nl), B-Platelet count(nl), Complete blood count (nl), B-Leucocytes differential count (%), B-HbA1c(%), S-ALAT (U/l), S-ASAT (U/l), S-GGT (U/l), P-Glucose (fasting)(mh/dl), S-prolactin level (ng/ml), S-Pregnancy test (IU/l), Qualitative analysis of urine with Stix®,Urine pregnancy. Comparing results with standard values.	4 month	No
Secondary	Evaluate Safety and Tolerability by Evaluation of Concomitant Medication	Listing of all concomitant medication to show the efficacy and safety.	4 month	No
Secondary	Evaluate Safety and Tolerability by Evaluation of the Incidence of Adverse Events	Listing of all adverse event or SAE´s to show the safety and tolerability.	4 month	No