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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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9 October 2012 |
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Main ID: |
EUCTR2007-007127-40-DE |
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Date of registration:
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28/02/2008 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Scientific title:
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CARE II - Evaluation of treatment outcomes in schizophrenic patients taking part in the integrated care program
- a single-country, multi-centre phase IV study
- CARE II |
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Date of first enrolment:
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10/09/2008 |
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Target sample size:
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200 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-007127-40 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: no
Open: yes
Single blind: no
Double blind: no
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: yes
Other specify the comparator: Participation in an Integrated Care Program at ratio of 3:1
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Phase:
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Countries of recruitment
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Germany
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
1. Provision of written informed consent to take part in the study
2. If applicable according to the intended treatment group allocation: Provision of written informed consent to start participation in an integrated health care program (ICP; the offered ICP services must be covered by a contract according to §§ 140 a-d SGB-V)
3. Patients with a baseline SWN-K total score of = 70
4. Male and female out-patients aged between 18 and 65 years
5. Treated or need of treatment for symptomatic schizophrenia (F20), schizo-affective disorder (F25), schizophreniform disorder (F23), delusional disorder (F22) or psychotic disorder not otherwise specified (F29), confirmed according to the ICD-10 definitions
6. Female patients of childbearing potential must have a negative serum pregnancy test at enrolment and be willing to use a reliable method of birth-control, i.e. double-barrier method, oral contraceptive, implant, dermal contraception, long-term injectable contraceptive, intrauterine device, or tubal ligation during the study
7. Ability to understand and comply with the study requirements as per the investigator
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
1. Current or previous participation in an integrated care program
2. Patients who in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others
3. Evidence of clinically relevant disease, e.g., renal or hepatic impairment, significant coronary artery disease, cerebrovascular disease, viral hepatitis B or C, acquired immunodeficiency syndrome (AIDS) as judged by the investigator
4. Patients with known cardiovascular diseases or other conditions predisposing to hypotension or family history of QT prolongation
5. Administration of a depot antipsychotic medication within one dosing interval prior to enrolment
6. Use of drugs that induce or inhibit the hepatic metabolizing CYP3A4 enzymes within 2 weeks prior to enrolment and throughout the 18-month treatment phase of the study (e.g., inducers: phenytoin, carbamazepine, phenobarbital, rifampicin, rifabutin, glucocorticoids, thioridazine and St John’s wort. E.g., inhibitors: ketoconazole (except for topical use), itraconazole, fluconazole, erythromycin, clarithromycin, fluvoxamin, nefadozone, troleandomycin, indinavir, nelfinavir, ritonavir and saquinavir).
7. Patients who are pregnant or lactating
8. Known intolerance or lack of response to the substance quetiapine
9. Neutropenia with an absolute neutrophil count (ANC) of ? 1.5 x 109 per litre.
10. Patients with unstable diabetes mellitus (DM)/HbA1c fulfilling one of the following criteria:
- Unstable DM defined as enrolment glycosylated haemoglobin (HbA1c) > 8.5%
- Patients admitted to hospital for treatment of DM or DM related illness in past 12 weeks
- Patients not under physician care for DM;
- Physician responsible for patient’s DM care has not indicated that patient’s DM is
controlled or has not approved patient’s participation in the study
- Patient has not been on the same dose of oral hypoglycaemic drug(s) and/or diet for the
4 weeks prior to enrolment - for thiazolidinediones (glitazones) not less than 8 weeks
- Patients taking insulin whose daily dose on one occasion in the past 4 weeks has been
more than 10% above or below their mean dose in the preceding 4 weeks.
(Note: If a diabetic patient meets one of these criteria, the patient must be excluded even if
the treating physician believes that the patient is stable and can participate in the study.)
11. Any contraindication as detailed in the German SmPC for quetiapine XR
12. Participation in another drug trial within 4 weeks prior enrolment into this study
13. Previous enrolment in the present study or CARE NIS
14. Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the investigational site)
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Symptomatic schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder or psychotic disorder not otherwise specified
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Intervention(s)
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Trade Name: Seroquel prolong 200 mg Retardtabletten
Product Name: Seroquel Prolong 200 mg Retardtabletten
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: Quetiapine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Trade Name: Seroquel prolong 300 mg Retardtabletten
Product Name: Seroquel Prolong 200 mg Retardtabletten
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: Quetiapine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-
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Primary Outcome(s)
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Secondary Objective: Secondary outcome measures to assess the treatment efficacy, compliance, quality of life, health economy issues and safety/tolerability.
Secondary study objectives will evaluate the influence of quetiapine XR with or without ICP participation on the following parameters during the study period:
Subjective well-being by SWN-K total score, symptomatic outcome by CGI-S and PANSS-8 scale, functional outcome by GAF, PSP, EQ-5D, and Vocational Occupational Index scores, quality of life by Q-LES-Q-18 questionnaire and RSM scale, patient engagement to therapy by SES scale, compliance/medication adherence by MARS scale, level of the patients' (subjective) satisfaction by CSQ-8 scale, health economy improvements, Safety and tolerability by evaluation of vital signs including weight/waist circumference, laboratory tests, concomitant medication, and the incidence of adverse events
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Primary end point(s): The primary outcome variable is the rate of patients with SWN-K score = 80 after 18 months. Exploratory 95% CIs will be calculated for this primary variable for each treatment group as well as for the difference between the treatment groups.
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Main Objective: Primary study objective is to assess the effect of quetiapine XR with or without concomitant participation in the ICP on the subjective well-being in patients treated for symptomatic schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder or psychotic disorder not otherwise specified, measured by the patients' self-report instrument SWN-K total score with a result of = 80 defined as the response limit for an adequate subjective well-being over a study treatment period of 18 months.
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Secondary ID(s)
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D1443L00048
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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