Trial Outcomes & Findings for Schizophrenic Patients in Integrated Care (NCT NCT00681629)
NCT ID: NCT00681629
Last Updated: 2012-07-30
Results Overview
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.
TERMINATED
PHASE4
7 participants
4 months
2012-07-30
Participant Flow
Study period July 2008 to November 2008; Centre Dr. Lambert (Hamburg), Centre Dr. Dorn (Berlin)
Participant milestones
| Measure |
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
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
2
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
5
|
2
|
Reasons for withdrawal
| Measure |
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
|
|---|---|---|
|
Overall Study
Study termination
|
4
|
2
|
|
Overall Study
Adverse Event
|
1
|
0
|
Baseline Characteristics
Schizophrenic Patients in Integrated Care
Baseline characteristics by cohort
| Measure |
Quetiapine XR With Integrated Care Program (ICP)
n=5 Participants
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
n=2 Participants
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
n=7 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
18-65 years
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 monthsPopulation: No data were reported as no participants completed the study
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 monthPopulation: No data were reported as no participants completed the study
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 monthPopulation: No data were reported as no participants completed the study
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 monthPopulation: No data were reported as no participants completed the study
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 monthPopulation: No data were reported as no participants completed the study
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 monthPopulation: No data were reported as no participants completed the study
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 monthPopulation: No data were reported as no participants completed the study
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 18 months (V1 Day 1, V2 Month 1, V3 Month 3, V4 Month 6, V5 Month 12, V6 Month 18)Population: No data were reported as no participants completed the study
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
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 monthPopulation: No data were reported as no participants completed the study
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 monthPopulation: No data were reported as no participants completed the study
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".
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 monthPopulation: No data were reported as no participants completed the study
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 monthPopulation: No data were reported as no participants completed the study
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 monthPopulation: No data were reported as no participants completed the study
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 monthPopulation: No data were reported as no participants completed the study
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 monthPopulation: No data were reported as no participants completed the study
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 monthPopulation: No data were reported as no participants completed the study
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 monthPopulation: No data were reported as no participants completed the study
Measuring of weight and waist circumference in centimeter.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 monthPopulation: No data were reported as no participants completed the study
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 monthPopulation: No data were reported as no participants completed the study
Listing of all concomitant medication to show the efficacy and safety.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 monthPopulation: No data were reported as no participants completed the study
Listing of all adverse event or SAE´s to show the safety and tolerability.
Outcome measures
Outcome data not reported
Adverse Events
Quetiapine XR With Integrated Care Program (ICP)
Quetiapine XR Alone
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Quetiapine XR With Integrated Care Program (ICP)
n=5 participants at risk
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
n=2 participants at risk
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
|
|---|---|---|
|
General disorders
Fatigue
|
20.0%
1/5
|
50.0%
1/2
|
|
Gastrointestinal disorders
Dry Mouth
|
20.0%
1/5
|
0.00%
0/2
|
|
Gastrointestinal disorders
Nausea
|
20.0%
1/5
|
0.00%
0/2
|
|
Investigations
Weight Increased
|
0.00%
0/5
|
50.0%
1/2
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/5
|
50.0%
1/2
|
|
Psychiatric disorders
Abnormal Dreams
|
20.0%
1/5
|
0.00%
0/2
|
|
Psychiatric disorders
Suicidal Ideation
|
0.00%
0/5
|
50.0%
1/2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Site has to inform sponsor about a publication at least 60 day in advance and 10 days before submission of an abstract or presentation. Change requests by the sponsor are recognized unless the scientific character or the objectivity is on risk. If the sponsor plans a patent application the publication has to be postponed up to 120 days.
- Publication restrictions are in place
Restriction type: OTHER