ID

19358

Description

Managing Acute Schizophrenia, a Comparison Between Two Atypical Antipsychotics; ODM derived from: https://clinicaltrials.gov/show/NCT00485498

Link

https://clinicaltrials.gov/show/NCT00485498

Keywords

  1. 12/21/16 12/21/16 -
Uploaded on

December 21, 2016

DOI

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License

Creative Commons BY 4.0

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Eligibility Schizophrenia NCT00485498

Eligibility Schizophrenia NCT00485498

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female subjects, aged 18 - 60
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
subjects must meet a clinical diagnosis of schizophrenia, schizophreniform disorder, or schizoaffective disorder according to dsm-iv
Description

Schizophrenia | Schizophreniform Disorders | Schizoaffective Disorder

Data type

boolean

Alias
UMLS CUI [1]
C0036341
UMLS CUI [2]
C0036358
UMLS CUI [3]
C0036337
subjects' illness must not, in the opinion of the investigator, be caused by substance abuse
Description

Illness caused by Substance Use Disorders

Data type

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0015127
UMLS CUI [1,3]
C0038586
bprs total score (1 to 7 scale) of greater than or equal to 36 at visit 1
Description

Brief Psychiatric Rating Scale

Data type

boolean

Alias
UMLS CUI [1]
C0029941
subjects must have a minimum total score of greater than or equal to 14 on the five items of the panss-ec and at least one individual item score of greater than or equal to 4 using the 1-7 scoring system prior to first dose of double-blind medications
Description

Positive and negative syndrome scale

Data type

boolean

Alias
UMLS CUI [1]
C0451383
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
treatment with antipsychotics or benzodiazepines within 4 hours prior to the first study drug administration
Description

Antipsychotic Agents | Benzodiazepines

Data type

boolean

Alias
UMLS CUI [1]
C0040615
UMLS CUI [2]
C0005064
treatment with an injectable depot neuroleptic within 1 injection interval prior to study drug administration
Description

Injection of depot antipsychotic agent

Data type

boolean

Alias
UMLS CUI [1]
C2585377
electroconvulsive therapy (ect) within 1 month (90 days) prior to study entry (visit 1)
Description

Electroconvulsive Therapy

Data type

boolean

Alias
UMLS CUI [1]
C0013806
treatment with remoxipride within 6 months (180 days) prior to visit 1
Description

Remoxipride

Data type

boolean

Alias
UMLS CUI [1]
C0073047
documented history of allergic reaction to study medications
Description

Allergic Reaction Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C0013230

Similar models

Eligibility Schizophrenia NCT00485498

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
male or female subjects, aged 18 - 60
boolean
C0001779 (UMLS CUI [1])
Schizophrenia | Schizophreniform Disorders | Schizoaffective Disorder
Item
subjects must meet a clinical diagnosis of schizophrenia, schizophreniform disorder, or schizoaffective disorder according to dsm-iv
boolean
C0036341 (UMLS CUI [1])
C0036358 (UMLS CUI [2])
C0036337 (UMLS CUI [3])
Illness caused by Substance Use Disorders
Item
subjects' illness must not, in the opinion of the investigator, be caused by substance abuse
boolean
C0221423 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
C0038586 (UMLS CUI [1,3])
Brief Psychiatric Rating Scale
Item
bprs total score (1 to 7 scale) of greater than or equal to 36 at visit 1
boolean
C0029941 (UMLS CUI [1])
Positive and negative syndrome scale
Item
subjects must have a minimum total score of greater than or equal to 14 on the five items of the panss-ec and at least one individual item score of greater than or equal to 4 using the 1-7 scoring system prior to first dose of double-blind medications
boolean
C0451383 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Antipsychotic Agents | Benzodiazepines
Item
treatment with antipsychotics or benzodiazepines within 4 hours prior to the first study drug administration
boolean
C0040615 (UMLS CUI [1])
C0005064 (UMLS CUI [2])
Injection of depot antipsychotic agent
Item
treatment with an injectable depot neuroleptic within 1 injection interval prior to study drug administration
boolean
C2585377 (UMLS CUI [1])
Electroconvulsive Therapy
Item
electroconvulsive therapy (ect) within 1 month (90 days) prior to study entry (visit 1)
boolean
C0013806 (UMLS CUI [1])
Remoxipride
Item
treatment with remoxipride within 6 months (180 days) prior to visit 1
boolean
C0073047 (UMLS CUI [1])
Allergic Reaction Investigational New Drugs
Item
documented history of allergic reaction to study medications
boolean
C1527304 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])

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