ID

19369

Description

Comparison of Intramuscular Olanzapine Depot to Oral Olanzapine and Low-Dose Depot in Patients With Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT00088491

Lien

https://clinicaltrials.gov/show/NCT00088491

Mots-clés

Versions (1)
  1. 22/12/2016 22/12/2016 -
Téléchargé le

22 décembre 2016

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Schizophrenic Disorders NCT00088491

Anglais

Eligibility Schizophrenic Disorders NCT00088491

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients must have schizophrenia
Description

Schizophrenia

Type de données

boolean

Alias
UMLS CUI [1]
C0036341
patients must be clinically stable on antipsychotic medication
Description

Antipsychotic Agents Clinical Stable

Type de données

boolean

Alias
UMLS CUI [1,1]
C0040615
UMLS CUI [1,2]
C0205210
UMLS CUI [1,3]
C0205360
patients must be retrospectively judged by investigators, based on clinical interview and impression, to have been stable (with respect to their symptoms of schizophrenia) for at least 4 weeks entry into the study
Description

Schizophrenia Symptoms Stable

Type de données

boolean

Alias
UMLS CUI [1,1]
C0036341
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0205360
patients must be an outpatient and have bprs positive items scores of 4 or less to enter the study
Description

Outpatients | Brief Psychiatric Rating Scale

Type de données

boolean

Alias
UMLS CUI [1]
C0029921
UMLS CUI [2]
C0029941
female patients of childbearing potential must be using a medically accepted means of contraception.
Description

Childbearing Potential Contraceptive methods

Type de données

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients must not have participated in a clinical trial of another investigational drug, including olanzapine, within 1 month (30 days) prior to study entry.
Description

Study Subject Participation Status | Investigational New Drugs | olanzapine

Type de données

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C0171023
female patients must not be pregnant or breast-feeding
Description

Pregnancy | Breast Feeding

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
patients must not be experiencing acute, serious, or unstable medical conditions other than schizophrenia
Description

Medical condition acute | Medical condition Serious | Medical condition Unstable | Schizophrenia

Type de données

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205178
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0205404
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C0443343
UMLS CUI [4]
C0036341
patients must not require concomitant treatment with any other medication with primarily central nervous system activity, including antidepressants, mood stabilizers, and anticonvulsants.
Description

Central Nervous System Agents Patient need for | Antidepressive Agents | Mood Stabilizer | Anticonvulsants

Type de données

boolean

Alias
UMLS CUI [1,1]
C0007680
UMLS CUI [1,2]
C0686904
UMLS CUI [2]
C0003289
UMLS CUI [3]
C2917435
UMLS CUI [4]
C0003286
patients must not have a substance (except nicotine or caffeine) dependence within the past 30 days
Description

Substance Dependence | Nicotine Dependence | Caffeine dependence

Type de données

boolean

Alias
UMLS CUI [1]
C0038580
UMLS CUI [2]
C0028043
UMLS CUI [3]
C1386553
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Similar models

Eligibility Schizophrenic Disorders NCT00088491

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Schizophrenia
Item
patients must have schizophrenia
boolean
C0036341 (UMLS CUI [1])
Antipsychotic Agents Clinical Stable
Item
patients must be clinically stable on antipsychotic medication
boolean
C0040615 (UMLS CUI [1,1])
C0205210 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
Schizophrenia Symptoms Stable
Item
patients must be retrospectively judged by investigators, based on clinical interview and impression, to have been stable (with respect to their symptoms of schizophrenia) for at least 4 weeks entry into the study
boolean
C0036341 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
Outpatients | Brief Psychiatric Rating Scale
Item
patients must be an outpatient and have bprs positive items scores of 4 or less to enter the study
boolean
C0029921 (UMLS CUI [1])
C0029941 (UMLS CUI [2])
Childbearing Potential Contraceptive methods
Item
female patients of childbearing potential must be using a medically accepted means of contraception.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Study Subject Participation Status | Investigational New Drugs | olanzapine
Item
patients must not have participated in a clinical trial of another investigational drug, including olanzapine, within 1 month (30 days) prior to study entry.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C0171023 (UMLS CUI [3])
Pregnancy | Breast Feeding
Item
female patients must not be pregnant or breast-feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Medical condition acute | Medical condition Serious | Medical condition Unstable | Schizophrenia
Item
patients must not be experiencing acute, serious, or unstable medical conditions other than schizophrenia
boolean
C3843040 (UMLS CUI [1,1])
C0205178 (UMLS CUI [1,2])
C3843040 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C3843040 (UMLS CUI [3,1])
C0443343 (UMLS CUI [3,2])
C0036341 (UMLS CUI [4])
Central Nervous System Agents Patient need for | Antidepressive Agents | Mood Stabilizer | Anticonvulsants
Item
patients must not require concomitant treatment with any other medication with primarily central nervous system activity, including antidepressants, mood stabilizers, and anticonvulsants.
boolean
C0007680 (UMLS CUI [1,1])
C0686904 (UMLS CUI [1,2])
C0003289 (UMLS CUI [2])
C2917435 (UMLS CUI [3])
C0003286 (UMLS CUI [4])
Substance Dependence | Nicotine Dependence | Caffeine dependence
Item
patients must not have a substance (except nicotine or caffeine) dependence within the past 30 days
boolean
C0038580 (UMLS CUI [1])
C0028043 (UMLS CUI [2])
C1386553 (UMLS CUI [3])
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