ID

37175

Description

An Open-Label Study of Aripiprazole Lauroxil in Subjects With Stable Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT02320032

Link

https://clinicaltrials.gov/show/NCT02320032

Keywords

  1. 7/6/19 7/6/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 6, 2019

DOI

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License

Creative Commons BY 4.0

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Eligibility Schizophrenia NCT02320032

Eligibility Schizophrenia NCT02320032

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
has stable schizophrenia or schizoaffective disorder
Description

Schizophrenia Stable | Schizoaffective Disorder

Data type

boolean

Alias
UMLS CUI [1,1]
C0036341
UMLS CUI [1,2]
C0205360
UMLS CUI [2]
C0036337
has demonstrated ability to tolerate aripiprazole
Description

Patient Tolerable Aripiprazole

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C4053931
UMLS CUI [1,3]
C0299792
has been on a stable antipsychotic medication regimen without any changes for at least 2 months prior to screening
Description

Antipsychotic drug therapy Stable Unchanged

Data type

boolean

Alias
UMLS CUI [1,1]
C1319421
UMLS CUI [1,2]
C0205360
UMLS CUI [1,3]
C0442739
has a body mass index (bmi) of 18.0 to 35.0 kg/m2, inclusive
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
additional criteria may apply
Description

Inclusion criteria Additional

Data type

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C1524062
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
is pregnant, breastfeeding, or is planning to become pregnant during the study period
Description

Pregnancy | Breast Feeding | Pregnancy, Planned

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
has received aripiprazole lauroxil or im depot aripiprazole within 6 months, or other long-acting, injectable antipsychotic medication within 3 months
Description

aripiprazole lauroxil | Depot Aripiprazole Intramuscular | Antipsychotic Agents Injectable Long-term Active

Data type

boolean

Alias
UMLS CUI [1]
C4056439
UMLS CUI [2,1]
C0086129
UMLS CUI [2,2]
C0299792
UMLS CUI [2,3]
C1556154
UMLS CUI [3,1]
C0040615
UMLS CUI [3,2]
C0086466
UMLS CUI [3,3]
C0443252
UMLS CUI [3,4]
C0205177
is a danger to himself/herself at screening or upon admission
Description

At risk for deliberate self harm

Data type

boolean

Alias
UMLS CUI [1]
C1276053
has a history of or positive test result for human immunodeficiency virus (hiv), hepatitis b, or hepatitis c
Description

HIV Infection | Hepatitis B | Hepatitis C | HIV Seropositivity | Hepatitis B positive | Hepatitis C positive

Data type

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0019196
UMLS CUI [4]
C0019699
UMLS CUI [5]
C0856706
UMLS CUI [6]
C1112419
has a positive urine drug screen at screening or day 1
Description

Urine drug screen positive

Data type

boolean

Alias
UMLS CUI [1]
C0743300
additional criteria may apply
Description

Exclusion Criteria Additional

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1524062

Similar models

Eligibility Schizophrenia NCT02320032

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Schizophrenia Stable | Schizoaffective Disorder
Item
has stable schizophrenia or schizoaffective disorder
boolean
C0036341 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0036337 (UMLS CUI [2])
Patient Tolerable Aripiprazole
Item
has demonstrated ability to tolerate aripiprazole
boolean
C0030705 (UMLS CUI [1,1])
C4053931 (UMLS CUI [1,2])
C0299792 (UMLS CUI [1,3])
Antipsychotic drug therapy Stable Unchanged
Item
has been on a stable antipsychotic medication regimen without any changes for at least 2 months prior to screening
boolean
C1319421 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0442739 (UMLS CUI [1,3])
Body mass index
Item
has a body mass index (bmi) of 18.0 to 35.0 kg/m2, inclusive
boolean
C1305855 (UMLS CUI [1])
Inclusion criteria Additional
Item
additional criteria may apply
boolean
C1512693 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
is pregnant, breastfeeding, or is planning to become pregnant during the study period
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
aripiprazole lauroxil | Depot Aripiprazole Intramuscular | Antipsychotic Agents Injectable Long-term Active
Item
has received aripiprazole lauroxil or im depot aripiprazole within 6 months, or other long-acting, injectable antipsychotic medication within 3 months
boolean
C4056439 (UMLS CUI [1])
C0086129 (UMLS CUI [2,1])
C0299792 (UMLS CUI [2,2])
C1556154 (UMLS CUI [2,3])
C0040615 (UMLS CUI [3,1])
C0086466 (UMLS CUI [3,2])
C0443252 (UMLS CUI [3,3])
C0205177 (UMLS CUI [3,4])
At risk for deliberate self harm
Item
is a danger to himself/herself at screening or upon admission
boolean
C1276053 (UMLS CUI [1])
HIV Infection | Hepatitis B | Hepatitis C | HIV Seropositivity | Hepatitis B positive | Hepatitis C positive
Item
has a history of or positive test result for human immunodeficiency virus (hiv), hepatitis b, or hepatitis c
boolean
C0019693 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
C0019699 (UMLS CUI [4])
C0856706 (UMLS CUI [5])
C1112419 (UMLS CUI [6])
Urine drug screen positive
Item
has a positive urine drug screen at screening or day 1
boolean
C0743300 (UMLS CUI [1])
Exclusion Criteria Additional
Item
additional criteria may apply
boolean
C0680251 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])

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