ID

37172

Beschrijving

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

Trefwoorden

Versies (1)
  1. 06-07-19 06-07-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

6 juli 2019

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility Schizophrenia NCT02054702

Engels

Eligibility Schizophrenia NCT02054702

1 Formulieren  
Inclusion Criteria
Beschrijving

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
Beschrijving

Age | Schizophrenia

Datatype

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
Beschrijving

Hospitalization benefits Schizophrenia relapse

Datatype

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:
Beschrijving

Exacerbation Psychotic symptoms | Deterioration Function Usual

Datatype

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
Beschrijving

PANSS Clinical Classification

Datatype

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
Beschrijving

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

Datatype

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)
Beschrijving

Clinical global impression scale

Datatype

boolean

Alias
UMLS CUI [1]
C3639708
Exclusion Criteria
Beschrijving

Exclusion Criteria

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

Schizophrenia First episode

Datatype

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
Beschrijving

Hospitalization Length of Stay Acute schizophrenic episode

Datatype

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.
Beschrijving

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

Datatype

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.
Beschrijving

Improvement Percentage PANSS Clinical Classification

Datatype

boolean

Alias
UMLS CUI [1,1]
C2986411
UMLS CUI [1,2]
C0439165
UMLS CUI [1,3]
C4086747
Terug naar het begin van de pagina

Similar models

Eligibility Schizophrenia NCT02054702

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Help

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