Informatie:
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ID
23824
Beschrijving
A Study for Patients With Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT00520923
Link
https://clinicaltrials.gov/show/NCT00520923
Trefwoorden
Versies (1)
- 14-07-17 14-07-17 -
Geüploaded op
14 juli 2017
DOI
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Licentie
Creative Commons BY 4.0
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Eligibility Schizophrenia NCT00520923
Eligibility Schizophrenia NCT00520923
- StudyEvent: Eligibility
Similar models
Eligibility Schizophrenia NCT00520923
- StudyEvent: Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
ID.1
Item
patients must have a diagnosis of schizophrenia as defined in diagnostic and statistical manual of mental disorders, fourth edition (dsm-iv) (disorganized, 295.10; catatonic, 295.20; paranoid, 295.30; residual, 295.60; or undifferentiated, 295.90) and confirmed by the structured clinical interview for dsm-iv (scid).
boolean
C0036341 (UMLS CUI [1])
ID.2
Item
patients must meet the following psychopathologic severity criteria at visit 1: brief psychiatric rating scale (bprs) total score, extracted from the positive and negative syndrome scale (panss), of at least 45 (18-item version, in which 1 indicates "absent" and 7 indicates "severe"). in addition, item scores of at least 4 (moderate) will be required on 2 of the following bprs items: conceptual disorganization, suspiciousness, hallucinatory behavior, and/or unusual thought content.
boolean
C0029941 (UMLS CUI [1,1])
C0451383 (UMLS CUI [1,2])
C0451383 (UMLS CUI [1,2])
ID.3
Item
patients must receive a rating of 4 (moderately ill) or greater on the clinical global impression-severity (cgi-s) scale at visit 1.
boolean
C3639708 (UMLS CUI [1])
ID.4
Item
patients in whom, in the opinion of the investigator, a switch to another antipsychotic medication or initiation of an antipsychotic medication is acutely indicated.
boolean
C0748066 (UMLS CUI [1,1])
C0748066 (UMLS CUI [1,2])
C0748066 (UMLS CUI [1,2])
ID.5
Item
some exclusion criteria:
boolean
ID.6
Item
patients in whom treatment with olanzapine or placebo is relatively or absolutely clinically contraindicated.
boolean
C0171023 (UMLS CUI [1,1])
C0032042 (UMLS CUI [1,2])
C0032042 (UMLS CUI [1,2])
ID.7
Item
patients who have a history of inadequate response to an adequate treatment trial with olanzapine, in the opinion of the investigator.
boolean
C1704632 (UMLS CUI [1,1])
C0171023 (UMLS CUI [1,2])
C0171023 (UMLS CUI [1,2])
ID.8
Item
patients who have received treatment with olanzapine within 6 weeks prior to visit 1.
boolean
C0171023 (UMLS CUI [1])
ID.9
Item
patients who have received treatment with clozapine at doses greater than 200 mg daily within 12 months prior to visit 1, or who have received any clozapine at all during the month before visit 1.
boolean
C0171023 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,2])
ID.10
Item
patients who have a history of an inadequate response, in the opinion of the investigator, to 2 or more adequate antipsychotic medication trials of at least 8 weeks duration in the past 12 months prior to visit 1.
boolean
C1704632 (UMLS CUI [1,1])
C1704632 (UMLS CUI [1,2])
C1704632 (UMLS CUI [1,2])
ID.11
Item
patients with acute, serious, or unstable medical conditions, including (but not limited to) inadequately controlled diabetes (hemoglobin a1c (hba1c) 8%), severe hypertriglyceridemia (fasting triglycerides 5.6 mmol/l, recent cerebrovascular accidents, serious acute systemic infection or immunologic disease, unstable cardiovascular disorders (including ischemic heart disease), malnutrition, hepatic, renal, gastroenterologic, respiratory, endocrinologic, neurologic, or hematologic diseases.
boolean
C1704632 (UMLS CUI [1])