ID

19347

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT00191555

Nyckelord

Versioner (1)
  1. 2016-12-19 2016-12-19 -
Uppladdad den

19 december 2016

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Eligibility Schizophrenia NCT00191555

Engelsk

Eligibility Schizophrenia NCT00191555

1 Formulär  
Inclusion Criteria
Beskrivning

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.
Beskrivning

Schizophrenia disease length | Antipsychotic Agents

Datatyp

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).
Beskrivning

Outpatients | Hospital admission Due to Social circumstances

Datatyp

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.
Beskrivning

Antipsychotic Agents conventional Same | Antipsychotic Agents Dose Stable

Datatyp

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.
Beskrivning

Positive and negative syndrome scale

Datatyp

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.
Beskrivning

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

Datatyp

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
Beskrivning

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.
Beskrivning

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

Datatyp

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.
Beskrivning

Atypical antipsychotic

Datatyp

boolean

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

Resistance Antipsychotic Agents

Datatyp

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.
Beskrivning

psychiatric hospitalization | Psychiatric emergency hospital admission

Datatyp

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.
Beskrivning

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

Datatyp

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
Tillbaka till toppen

Similar models

Eligibility Schizophrenia NCT00191555

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial