ID

37172

Description

Brexpiprazole (OPC-34712) Trial in the Treatment of Adults With Acute Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT02054702

Link

https://clinicaltrials.gov/show/NCT02054702

Keywords

Versions (1)
  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 NCT02054702

English

Eligibility Schizophrenia NCT02054702

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
18 to 65 years of age, inclusive, at the time of informed consent with a diagnosis of schizophrenia as defined by the diagnostic and statistical manual of mental disorders, fourth edition, text revision (dsm-iv-tr) and confirmed by the mini international neuropsychiatric interview (m.i.n.i) for schizophrenia and psychotic disorders studies
Description

Age | Schizophrenia

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0036341
would benefit from hospitalization or continued hospitalization for treatment of a current acute relapse of schizophrenia at trial entry
Description

Hospitalization benefits Schizophrenia relapse

Data type

boolean

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C0814225
UMLS CUI [1,3]
C1536217
are experiencing an acute exacerbation of psychotic symptoms and marked deterioration of usual function as demonstrated by all of the following:
Description

Exacerbation Psychotic symptoms | Deterioration Function Usual

Data type

boolean

Alias
UMLS CUI [1,1]
C4086268
UMLS CUI [1,2]
C0871189
UMLS CUI [2,1]
C0868945
UMLS CUI [2,2]
C0542341
UMLS CUI [2,3]
C3538928
positive and negative syndrome scale (panss) total score of ≥ 80
Description

PANSS Clinical Classification

Data type

boolean

Alias
UMLS CUI [1]
C4086747
score of ≥ 4 on two or more of the following panss items at screening: hallucinatory behavior, unusual thought content, conceptual disorganization, or suspiciousness
Description

PANSS Clinical Classification Item score | Hallucinatory Behavior | Unusual Thought Content | Conceptual Disorganization | Suspiciousness

Data type

boolean

Alias
UMLS CUI [1,1]
C4086747
UMLS CUI [1,2]
C0559741
UMLS CUI [2]
C4086696
UMLS CUI [3]
C4086711
UMLS CUI [4]
C4086687
UMLS CUI [5]
C4087067
clinical global impression - severity of illness scale (cgi-s) score ≥ 4 (moderately ill)
Description

Clinical global impression scale

Data type

boolean

Alias
UMLS CUI [1]
C3639708
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
are presenting with a first episode of schizophrenia based on the clinical judgment of the investigator
Description

Schizophrenia First episode

Data type

boolean

Alias
UMLS CUI [1,1]
C0036341
UMLS CUI [1,2]
C0439615
have been hospitalized > 21 days for the current acute episode at the time of the baseline visit
Description

Hospitalization Length of Stay Acute schizophrenic episode

Data type

boolean

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C0023303
UMLS CUI [1,3]
C0813173
have a current dsm-iv-tr axis i diagnosis other than schizophrenia, including, but not limited to, schizoaffective disorder, major depressive disorder (mdd), bipolar disorder, post-traumatic stress disorder, anxiety disorders, delirium, dementia, amnestic, or other cognitive disorders; also borderline, paranoid, histrionic, schizotypal, schizoid, antisocial personality disorders or mental retardation.
Description

Axis I diagnosis | Exception Schizophrenia | Schizoaffective Disorder | Major Depressive Disorder | Bipolar Disorder | Post-Traumatic Stress Disorder | Anxiety Disorders | Delirium | Dementia | Amnestic Disorder | Cognition Disorders | Borderline Personality Disorder | Paranoid Personality Disorder | Histrionic Personality Disorder | Schizotypal Personality Disorder | Schizoid Personality Disorder | Antisocial Personality Disorder | Mental Retardation

Data type

boolean

Alias
UMLS CUI [1]
C0270287
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0036341
UMLS CUI [3]
C0036337
UMLS CUI [4]
C1269683
UMLS CUI [5]
C0005586
UMLS CUI [6]
C0038436
UMLS CUI [7]
C0003469
UMLS CUI [8]
C0011206
UMLS CUI [9]
C0497327
UMLS CUI [10]
C0002625
UMLS CUI [11]
C0009241
UMLS CUI [12]
C0006012
UMLS CUI [13]
C0030477
UMLS CUI [14]
C0019681
UMLS CUI [15]
C0036363
UMLS CUI [16]
C0036339
UMLS CUI [17]
C0003431
UMLS CUI [18]
C0025362
improvement of ≥ 20% in total panss score between the screening and baseline assessments.
Description

Improvement Percentage PANSS Clinical Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C2986411
UMLS CUI [1,2]
C0439165
UMLS CUI [1,3]
C4086747
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Similar models

Eligibility Schizophrenia NCT02054702

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age | Schizophrenia
Item
18 to 65 years of age, inclusive, at the time of informed consent with a diagnosis of schizophrenia as defined by the diagnostic and statistical manual of mental disorders, fourth edition, text revision (dsm-iv-tr) and confirmed by the mini international neuropsychiatric interview (m.i.n.i) for schizophrenia and psychotic disorders studies
boolean
C0001779 (UMLS CUI [1])
C0036341 (UMLS CUI [2])
Hospitalization benefits Schizophrenia relapse
Item
would benefit from hospitalization or continued hospitalization for treatment of a current acute relapse of schizophrenia at trial entry
boolean
C0019993 (UMLS CUI [1,1])
C0814225 (UMLS CUI [1,2])
C1536217 (UMLS CUI [1,3])
Exacerbation Psychotic symptoms | Deterioration Function Usual
Item
are experiencing an acute exacerbation of psychotic symptoms and marked deterioration of usual function as demonstrated by all of the following:
boolean
C4086268 (UMLS CUI [1,1])
C0871189 (UMLS CUI [1,2])
C0868945 (UMLS CUI [2,1])
C0542341 (UMLS CUI [2,2])
C3538928 (UMLS CUI [2,3])
PANSS Clinical Classification
Item
positive and negative syndrome scale (panss) total score of ≥ 80
boolean
C4086747 (UMLS CUI [1])
PANSS Clinical Classification Item score | Hallucinatory Behavior | Unusual Thought Content | Conceptual Disorganization | Suspiciousness
Item
score of ≥ 4 on two or more of the following panss items at screening: hallucinatory behavior, unusual thought content, conceptual disorganization, or suspiciousness
boolean
C4086747 (UMLS CUI [1,1])
C0559741 (UMLS CUI [1,2])
C4086696 (UMLS CUI [2])
C4086711 (UMLS CUI [3])
C4086687 (UMLS CUI [4])
C4087067 (UMLS CUI [5])
Clinical global impression scale
Item
clinical global impression - severity of illness scale (cgi-s) score ≥ 4 (moderately ill)
boolean
C3639708 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Schizophrenia First episode
Item
are presenting with a first episode of schizophrenia based on the clinical judgment of the investigator
boolean
C0036341 (UMLS CUI [1,1])
C0439615 (UMLS CUI [1,2])
Hospitalization Length of Stay Acute schizophrenic episode
Item
have been hospitalized > 21 days for the current acute episode at the time of the baseline visit
boolean
C0019993 (UMLS CUI [1,1])
C0023303 (UMLS CUI [1,2])
C0813173 (UMLS CUI [1,3])
Axis I diagnosis | Exception Schizophrenia | Schizoaffective Disorder | Major Depressive Disorder | Bipolar Disorder | Post-Traumatic Stress Disorder | Anxiety Disorders | Delirium | Dementia | Amnestic Disorder | Cognition Disorders | Borderline Personality Disorder | Paranoid Personality Disorder | Histrionic Personality Disorder | Schizotypal Personality Disorder | Schizoid Personality Disorder | Antisocial Personality Disorder | Mental Retardation
Item
have a current dsm-iv-tr axis i diagnosis other than schizophrenia, including, but not limited to, schizoaffective disorder, major depressive disorder (mdd), bipolar disorder, post-traumatic stress disorder, anxiety disorders, delirium, dementia, amnestic, or other cognitive disorders; also borderline, paranoid, histrionic, schizotypal, schizoid, antisocial personality disorders or mental retardation.
boolean
C0270287 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0036341 (UMLS CUI [2,2])
C0036337 (UMLS CUI [3])
C1269683 (UMLS CUI [4])
C0005586 (UMLS CUI [5])
C0038436 (UMLS CUI [6])
C0003469 (UMLS CUI [7])
C0011206 (UMLS CUI [8])
C0497327 (UMLS CUI [9])
C0002625 (UMLS CUI [10])
C0009241 (UMLS CUI [11])
C0006012 (UMLS CUI [12])
C0030477 (UMLS CUI [13])
C0019681 (UMLS CUI [14])
C0036363 (UMLS CUI [15])
C0036339 (UMLS CUI [16])
C0003431 (UMLS CUI [17])
C0025362 (UMLS CUI [18])
Improvement Percentage PANSS Clinical Classification
Item
improvement of ≥ 20% in total panss score between the screening and baseline assessments.
boolean
C2986411 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
C4086747 (UMLS CUI [1,3])
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