ID

13769

Description

SPD489 as Adjunctive Treatment in Adults With Negative Symptoms of Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT01234298

Link

https://clinicaltrials.gov/show/NCT01234298

Keywords

  1. 3/6/16 3/6/16 -
Uploaded on

March 6, 2016

DOI

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License

Creative Commons BY 4.0

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Eligibility Negative Symptoms of Schizophrenia NCT01234298

Eligibility Negative Symptoms of Schizophrenia NCT01234298

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
subject has diagnosis of schizophrenia for at least 2 years
Description

schizophrenia

Data type

boolean

Alias
UMLS CUI [1]
C0036341
subject has persistent predominant negative symptoms
Description

symptoms negative

Data type

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0205160
subject has 2 or more persistent predominant negative symptoms (affective flattening, alogia, avolition apathy, and anhedonia-asociality) determined to have been present for at least 6 months
Description

symptoms negative; alogia

Data type

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0205160
UMLS CUI [2]
C0003537
subject is maintained on antipsychotic monotherapy or polytherapy with no more than 2 antipsychotic medications
Description

PSYCHIATRIC TREATMENT ANTIPSYCHOTIC MEDICATION

Data type

boolean

Alias
UMLS CUI [1]
C0748066
subject has been clinically stable and is in the non-acute phase of illness
Description

Stable Disease

Data type

boolean

Alias
UMLS CUI [1]
C0677946
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
subject has clinically notable positive symptoms
Description

symptoms positive

Data type

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C1446409
subject is considered to be treatment refractory
Description

treatment refractory

Data type

boolean

Alias
UMLS CUI [1]
C0205269
subject has current history of substance abuse/dependance
Description

Substance Use Disorder

Data type

boolean

Alias
UMLS CUI [1]
C0038586
subject is considered a suicide risk or risk to harm others
Description

suicidal

Data type

boolean

Alias
UMLS CUI [1]
C0438696

Similar models

Eligibility Negative Symptoms of Schizophrenia NCT01234298

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
schizophrenia
Item
subject has diagnosis of schizophrenia for at least 2 years
boolean
C0036341 (UMLS CUI [1])
symptoms negative
Item
subject has persistent predominant negative symptoms
boolean
C1457887 (UMLS CUI [1,1])
C0205160 (UMLS CUI [1,2])
symptoms negative; alogia
Item
subject has 2 or more persistent predominant negative symptoms (affective flattening, alogia, avolition apathy, and anhedonia-asociality) determined to have been present for at least 6 months
boolean
C1457887 (UMLS CUI [1,1])
C0205160 (UMLS CUI [1,2])
C0003537 (UMLS CUI [2])
PSYCHIATRIC TREATMENT ANTIPSYCHOTIC MEDICATION
Item
subject is maintained on antipsychotic monotherapy or polytherapy with no more than 2 antipsychotic medications
boolean
C0748066 (UMLS CUI [1])
Stable Disease
Item
subject has been clinically stable and is in the non-acute phase of illness
boolean
C0677946 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
symptoms positive
Item
subject has clinically notable positive symptoms
boolean
C1457887 (UMLS CUI [1,1])
C1446409 (UMLS CUI [1,2])
treatment refractory
Item
subject is considered to be treatment refractory
boolean
C0205269 (UMLS CUI [1])
Substance Use Disorder
Item
subject has current history of substance abuse/dependance
boolean
C0038586 (UMLS CUI [1])
suicidal
Item
subject is considered a suicide risk or risk to harm others
boolean
C0438696 (UMLS CUI [1])

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