ID

32145

Beschreibung

Efficacy and Safety of Risperidone Oral Solution Combination Clonazepam Versus Haloperidol Intramuscular (IM) Injection for Treatment of Acute Psychotic Agitation in Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT00859872

Link

https://clinicaltrials.gov/show/NCT00859872

Stichworte

Versionen (1)
  1. 21.10.18 21.10.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

21. Oktober 2018

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT00859872

Englisch

Eligibility Schizophrenia NCT00859872

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
men or women aged 18 to 45 years
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
dsm-iv diagnosis of acute exacerbation of schizophrenia or schizoaffective disorders
Beschreibung

Schizophrenia Acute exacerbation | Schizoaffective Disorder Acute exacerbation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0036341
UMLS CUI [1,2]
C0743630
UMLS CUI [2,1]
C0036337
UMLS CUI [2,2]
C0743630
a score of ≥ 14 on a 5-item acute-agitation cluster (including excitement, hostility, uncooperativeness and poor impulse control) derived from the pnass
Beschreibung

Agitation Cluster Score | Relationship PANSS | PANSS - Excitement | PANSS - Hostility | PANSS - Uncooperativeness | PANSS - Poor Impulse Control

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0085631
UMLS CUI [1,2]
C1704332
UMLS CUI [1,3]
C0449820
UMLS CUI [2,1]
C0439849
UMLS CUI [2,2]
C4086747
UMLS CUI [3]
C4086693
UMLS CUI [4]
C4086697
UMLS CUI [5]
C4086710
UMLS CUI [6]
C4086704
the total scores ≥60 on the panss
Beschreibung

PANSS

Datentyp

boolean

Alias
UMLS CUI [1]
C4086747
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
women who are pregnant or breast feeding, or who plan to become pregnant during the study
Beschreibung

Pregnancy | Breast Feeding | Pregnancy, Planned

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
the psychotic agitation is caused by delirium, epilepsy, mental retardation and affective disorder; intoxication or symptoms of withdrawal from alcohol or other psychoactive substances
Beschreibung

Agitation Psychotic caused by Delirium | Agitation Psychotic caused by Epilepsy | Agitation Psychotic caused by Mental Retardation | Agitation Psychotic caused by Mood Disorders | Alcoholic Intoxication | Psychoactive substance intoxication | Alcohol consumption Withdrawal Symptoms | Psychoactive substance Withdrawal Symptoms

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0085631
UMLS CUI [1,2]
C0033975
UMLS CUI [1,3]
C0015127
UMLS CUI [1,4]
C0011206
UMLS CUI [2,1]
C0085631
UMLS CUI [2,2]
C0033975
UMLS CUI [2,3]
C0015127
UMLS CUI [2,4]
C0014544
UMLS CUI [3,1]
C0085631
UMLS CUI [3,2]
C0033975
UMLS CUI [3,3]
C0015127
UMLS CUI [3,4]
C0025362
UMLS CUI [4,1]
C0085631
UMLS CUI [4,2]
C0033975
UMLS CUI [4,3]
C0015127
UMLS CUI [4,4]
C0525045
UMLS CUI [5]
C0001969
UMLS CUI [6]
C1401172
UMLS CUI [7,1]
C0001948
UMLS CUI [7,2]
C0087169
UMLS CUI [8,1]
C0682880
UMLS CUI [8,2]
C0087169
clinical laboratory values indicating serious medical illness
Beschreibung

Illness Serious Laboratory Results

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C1254595
known hypersensitivity to any of the study medications
Beschreibung

Hypersensitivity Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
treatment with a depot antipsychotic with 1 cycle of screening
Beschreibung

Injection of depot antipsychotic agent | Screening procedure Quantity

Datentyp

boolean

Alias
UMLS CUI [1]
C2585377
UMLS CUI [2,1]
C0220908
UMLS CUI [2,2]
C1265611
using of disallowed medication
Beschreibung

Illicit medication use

Datentyp

boolean

Alias
UMLS CUI [1]
C0281875
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Ähnliche Modelle

Eligibility Schizophrenia NCT00859872

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
men or women aged 18 to 45 years
boolean
C0001779 (UMLS CUI [1])
Schizophrenia Acute exacerbation | Schizoaffective Disorder Acute exacerbation
Item
dsm-iv diagnosis of acute exacerbation of schizophrenia or schizoaffective disorders
boolean
C0036341 (UMLS CUI [1,1])
C0743630 (UMLS CUI [1,2])
C0036337 (UMLS CUI [2,1])
C0743630 (UMLS CUI [2,2])
Agitation Cluster Score | Relationship PANSS | PANSS - Excitement | PANSS - Hostility | PANSS - Uncooperativeness | PANSS - Poor Impulse Control
Item
a score of ≥ 14 on a 5-item acute-agitation cluster (including excitement, hostility, uncooperativeness and poor impulse control) derived from the pnass
boolean
C0085631 (UMLS CUI [1,1])
C1704332 (UMLS CUI [1,2])
C0449820 (UMLS CUI [1,3])
C0439849 (UMLS CUI [2,1])
C4086747 (UMLS CUI [2,2])
C4086693 (UMLS CUI [3])
C4086697 (UMLS CUI [4])
C4086710 (UMLS CUI [5])
C4086704 (UMLS CUI [6])
PANSS
Item
the total scores ≥60 on the panss
boolean
C4086747 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
women who are pregnant or breast feeding, or who plan to become pregnant during the study
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Agitation Psychotic caused by Delirium | Agitation Psychotic caused by Epilepsy | Agitation Psychotic caused by Mental Retardation | Agitation Psychotic caused by Mood Disorders | Alcoholic Intoxication | Psychoactive substance intoxication | Alcohol consumption Withdrawal Symptoms | Psychoactive substance Withdrawal Symptoms
Item
the psychotic agitation is caused by delirium, epilepsy, mental retardation and affective disorder; intoxication or symptoms of withdrawal from alcohol or other psychoactive substances
boolean
C0085631 (UMLS CUI [1,1])
C0033975 (UMLS CUI [1,2])
C0015127 (UMLS CUI [1,3])
C0011206 (UMLS CUI [1,4])
C0085631 (UMLS CUI [2,1])
C0033975 (UMLS CUI [2,2])
C0015127 (UMLS CUI [2,3])
C0014544 (UMLS CUI [2,4])
C0085631 (UMLS CUI [3,1])
C0033975 (UMLS CUI [3,2])
C0015127 (UMLS CUI [3,3])
C0025362 (UMLS CUI [3,4])
C0085631 (UMLS CUI [4,1])
C0033975 (UMLS CUI [4,2])
C0015127 (UMLS CUI [4,3])
C0525045 (UMLS CUI [4,4])
C0001969 (UMLS CUI [5])
C1401172 (UMLS CUI [6])
C0001948 (UMLS CUI [7,1])
C0087169 (UMLS CUI [7,2])
C0682880 (UMLS CUI [8,1])
C0087169 (UMLS CUI [8,2])
Illness Serious Laboratory Results
Item
clinical laboratory values indicating serious medical illness
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C1254595 (UMLS CUI [1,3])
Hypersensitivity Investigational New Drugs
Item
known hypersensitivity to any of the study medications
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Injection of depot antipsychotic agent | Screening procedure Quantity
Item
treatment with a depot antipsychotic with 1 cycle of screening
boolean
C2585377 (UMLS CUI [1])
C0220908 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
Illicit medication use
Item
using of disallowed medication
boolean
C0281875 (UMLS CUI [1])
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