ID

19347

Description

Efficacy Study of Switching Stabilized Schizophrenic Patients From Conventional to Atypical Antipsychotic Treatment; ODM derived from: https://clinicaltrials.gov/show/NCT00191555

Lien

https://clinicaltrials.gov/show/NCT00191555

Mots-clés

Versions (1)
  1. 19/12/2016 19/12/2016 -
Téléchargé le

19 décembre 2016

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT00191555

Anglais

Eligibility Schizophrenia NCT00191555

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
schizophrenic patient meeting the dsm-iv diagnostic criteria more than one year ago and treated with antipsychotic for at least 1 year.
Description

Schizophrenia disease length | Antipsychotic Agents

Type de données

boolean

Alias
UMLS CUI [1,1]
C0036341
UMLS CUI [1,2]
C0872146
UMLS CUI [2]
C0040615
outpatient (or patient admitted to hospital for social or logistic reasons).
Description

Outpatients | Hospital admission Due to Social circumstances

Type de données

boolean

Alias
UMLS CUI [1]
C0029921
UMLS CUI [2,1]
C0184666
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0851364
patient receiving a stable dose of the same conventional antipsychotic for at least 8 weeks before visit 1.
Description

Antipsychotic Agents conventional Same | Antipsychotic Agents Dose Stable

Type de données

boolean

Alias
UMLS CUI [1,1]
C0040615
UMLS CUI [1,2]
C0439858
UMLS CUI [1,3]
C0445247
UMLS CUI [2,1]
C0040615
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205360
patient presenting a panss score equal or greater than 49 at visit 2.
Description

Positive and negative syndrome scale

Type de données

boolean

Alias
UMLS CUI [1]
C0451383
patient considered by the investigator as possible candidates for a switch, owing to inadequate efficacy or poor safety of the current treatment.
Description

Indication Therapy change | Therapeutic procedure Lack of Efficacy | Therapeutic procedure Safety Poor

Type de données

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C3665894
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0235828
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C0036043
UMLS CUI [3,3]
C0542537
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient presenting a schizophreniform or a schizo-affective disorder according to the dsm-iv diagnostic criteria, or any other disorder from axis i of the dsm-iv, or a disorder from axis ii (limit personality), substance dependence or substance abuse.
Description

Schizophreniform Disorders | Schizoaffective Disorder | Axis I diagnosis | Axis II diagnosis | Substance Dependence | Substance Use Disorders

Type de données

boolean

Alias
UMLS CUI [1]
C0036358
UMLS CUI [2]
C0036337
UMLS CUI [3]
C0270287
UMLS CUI [4]
C0270288
UMLS CUI [5]
C0038580
UMLS CUI [6]
C0038586
administration of an atypical antipsychotic drug during the 8 weeks preceding v1.
Description

Atypical antipsychotic

Type de données

boolean

Alias
UMLS CUI [1]
C1276996
history of resistance to antipsychotic drugs
Description

Resistance Antipsychotic Agents

Type de données

boolean

Alias
UMLS CUI [1,1]
C1514892
UMLS CUI [1,2]
C0040615
hospitalization in a psychiatric unit or in a psychiatric emergency department within the 8 weeks preceding the beginning of the study.
Description

psychiatric hospitalization | Psychiatric emergency hospital admission

Type de données

boolean

Alias
UMLS CUI [1]
C0748061
UMLS CUI [2]
C0420275
presence of serious unstable disease, such as a fatal outcome or hospitalization in an intensive care unit, is foreseeable within a period of 6 months.
Description

Disease Unstable Serious | Fatal Outcome | Admission to intensive care unit

Type de données

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0443343
UMLS CUI [1,3]
C0205404
UMLS CUI [2]
C0206277
UMLS CUI [3]
C0583239
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Similar models

Eligibility Schizophrenia NCT00191555

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Schizophrenia disease length | Antipsychotic Agents
Item
schizophrenic patient meeting the dsm-iv diagnostic criteria more than one year ago and treated with antipsychotic for at least 1 year.
boolean
C0036341 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C0040615 (UMLS CUI [2])
Outpatients | Hospital admission Due to Social circumstances
Item
outpatient (or patient admitted to hospital for social or logistic reasons).
boolean
C0029921 (UMLS CUI [1])
C0184666 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0851364 (UMLS CUI [2,3])
Antipsychotic Agents conventional Same | Antipsychotic Agents Dose Stable
Item
patient receiving a stable dose of the same conventional antipsychotic for at least 8 weeks before visit 1.
boolean
C0040615 (UMLS CUI [1,1])
C0439858 (UMLS CUI [1,2])
C0445247 (UMLS CUI [1,3])
C0040615 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
Positive and negative syndrome scale
Item
patient presenting a panss score equal or greater than 49 at visit 2.
boolean
C0451383 (UMLS CUI [1])
Indication Therapy change | Therapeutic procedure Lack of Efficacy | Therapeutic procedure Safety Poor
Item
patient considered by the investigator as possible candidates for a switch, owing to inadequate efficacy or poor safety of the current treatment.
boolean
C3146298 (UMLS CUI [1,1])
C3665894 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C0235828 (UMLS CUI [2,2])
C0087111 (UMLS CUI [3,1])
C0036043 (UMLS CUI [3,2])
C0542537 (UMLS CUI [3,3])
Item Group
C0680251 (UMLS CUI)
Schizophreniform Disorders | Schizoaffective Disorder | Axis I diagnosis | Axis II diagnosis | Substance Dependence | Substance Use Disorders
Item
patient presenting a schizophreniform or a schizo-affective disorder according to the dsm-iv diagnostic criteria, or any other disorder from axis i of the dsm-iv, or a disorder from axis ii (limit personality), substance dependence or substance abuse.
boolean
C0036358 (UMLS CUI [1])
C0036337 (UMLS CUI [2])
C0270287 (UMLS CUI [3])
C0270288 (UMLS CUI [4])
C0038580 (UMLS CUI [5])
C0038586 (UMLS CUI [6])
Atypical antipsychotic
Item
administration of an atypical antipsychotic drug during the 8 weeks preceding v1.
boolean
C1276996 (UMLS CUI [1])
Resistance Antipsychotic Agents
Item
history of resistance to antipsychotic drugs
boolean
C1514892 (UMLS CUI [1,1])
C0040615 (UMLS CUI [1,2])
psychiatric hospitalization | Psychiatric emergency hospital admission
Item
hospitalization in a psychiatric unit or in a psychiatric emergency department within the 8 weeks preceding the beginning of the study.
boolean
C0748061 (UMLS CUI [1])
C0420275 (UMLS CUI [2])
Disease Unstable Serious | Fatal Outcome | Admission to intensive care unit
Item
presence of serious unstable disease, such as a fatal outcome or hospitalization in an intensive care unit, is foreseeable within a period of 6 months.
boolean
C0012634 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0205404 (UMLS CUI [1,3])
C0206277 (UMLS CUI [2])
C0583239 (UMLS CUI [3])
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