ID

19264

Description

Study Of An FDA-approved Drug As Additional Therapy In Patients With Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT00086593

Link

https://clinicaltrials.gov/show/NCT00086593

Keywords

Versions (3)
  1. 12/16/16 12/16/16 -
  2. 4/19/18 4/19/18 - Sarah Riepenhausen
  3. 9/20/21 9/20/21 -
Uploaded on

December 16, 2016

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Schizophrenia NCT00086593

English

Eligibility Schizophrenia NCT00086593

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosed with schizophrenia.
Description

Schizophrenia

Data type

boolean

Alias
UMLS CUI [1]
C0036341
exhibits persistent positive symptoms that have persisted for a minimum of 3 months prior to screening.
Description

Symptoms Positive persistent

Data type

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C1514241
UMLS CUI [1,3]
C0205322
continuously taking 1-2 specific atypical antipsychotics for a minimum of 3 months and must be on a stable dose for at least 1 month prior to entering the study.
Description

Atypical antipsychotic Specific Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C1276996
UMLS CUI [1,2]
C0205369
UMLS CUI [1,3]
C1265611
participant or a legal guardian is able to understand and sign the consent form.
Description

Informed Consent | Informed Consent Legal Guardian

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0023226
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
panss (positive and negative syndrome score) total score increases or decreases by more than 20% between the screening and baseline visits.
Description

Positive and negative syndrome scale Increase Percent | Positive and negative syndrome scale Decrease Percentage

Data type

boolean

Alias
UMLS CUI [1,1]
C0451383
UMLS CUI [1,2]
C0442805
UMLS CUI [1,3]
C0439165
UMLS CUI [2,1]
C0451383
UMLS CUI [2,2]
C0547047
UMLS CUI [2,3]
C0439165
predominant axis i disorder other than schizophrenia within 6 months prior to screening.
Description

Axis I diagnosis predominant | Schizophrenia

Data type

boolean

Alias
UMLS CUI [1,1]
C0270287
UMLS CUI [1,2]
C1542147
UMLS CUI [2]
C0036341
history of clinically significant or unstable medical disorder or treatment that would interfere with the study.
Description

Disease Clinical Significance Interferes with Clinical Trial | Disease Unstable Interferes with Clinical Trial | Therapeutic procedure Clinical Significance Interferes with Clinical Trial | Therapeutic procedure Unstable Interferes with Clinical Trial

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2826293
UMLS CUI [1,3]
C0521102
UMLS CUI [1,4]
C0008976
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0443343
UMLS CUI [2,3]
C0521102
UMLS CUI [2,4]
C0008976
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C2826293
UMLS CUI [3,3]
C0521102
UMLS CUI [3,4]
C0008976
UMLS CUI [4,1]
C0087111
UMLS CUI [4,2]
C0443343
UMLS CUI [4,3]
C0521102
UMLS CUI [4,4]
C0008976
history of autistic disorder or another pervasive developmental disorder, organic brain disease, dementia, stroke, epilepsy or a history of seizures requiring treatment (this does not include febrile seizures as a child), or those who have suffered a traumatic head injury.
Description

Autistic Disorder | Pervasive Development Disorder | Organic brain disorder | Dementia | Cerebrovascular accident | Epilepsy | Seizures Requirement Therapeutic procedure | Febrile Convulsions | Craniocerebral Trauma

Data type

boolean

Alias
UMLS CUI [1]
C0004352
UMLS CUI [2]
C0524528
UMLS CUI [3]
C4062280
UMLS CUI [4]
C0497327
UMLS CUI [5]
C0038454
UMLS CUI [6]
C0014544
UMLS CUI [7,1]
C0036572
UMLS CUI [7,2]
C1514873
UMLS CUI [7,3]
C0087111
UMLS CUI [8]
C0009952
UMLS CUI [9]
C0018674
taking psychotropic or primarily centrally active medication at screening.
Description

Psychotropic Drugs | Central Nervous System Agents Primary

Data type

boolean

Alias
UMLS CUI [1]
C0033978
UMLS CUI [2,1]
C0007680
UMLS CUI [2,2]
C0205225
use of antidepressant medications or mood stabilizers within 1 month of screening.
Description

Antidepressive Agents | Mood Stabilizer

Data type

boolean

Alias
UMLS CUI [1]
C0003289
UMLS CUI [2]
C2917435
Back to the top of the page

Similar models

Eligibility Schizophrenia NCT00086593

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Schizophrenia
Item
diagnosed with schizophrenia.
boolean
C0036341 (UMLS CUI [1])
Symptoms Positive persistent
Item
exhibits persistent positive symptoms that have persisted for a minimum of 3 months prior to screening.
boolean
C1457887 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
C0205322 (UMLS CUI [1,3])
Atypical antipsychotic Specific Quantity
Item
continuously taking 1-2 specific atypical antipsychotics for a minimum of 3 months and must be on a stable dose for at least 1 month prior to entering the study.
boolean
C1276996 (UMLS CUI [1,1])
C0205369 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Informed Consent | Informed Consent Legal Guardian
Item
participant or a legal guardian is able to understand and sign the consent form.
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0023226 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Positive and negative syndrome scale Increase Percent | Positive and negative syndrome scale Decrease Percentage
Item
panss (positive and negative syndrome score) total score increases or decreases by more than 20% between the screening and baseline visits.
boolean
C0451383 (UMLS CUI [1,1])
C0442805 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
C0451383 (UMLS CUI [2,1])
C0547047 (UMLS CUI [2,2])
C0439165 (UMLS CUI [2,3])
Axis I diagnosis predominant | Schizophrenia
Item
predominant axis i disorder other than schizophrenia within 6 months prior to screening.
boolean
C0270287 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
C0036341 (UMLS CUI [2])
Disease Clinical Significance Interferes with Clinical Trial | Disease Unstable Interferes with Clinical Trial | Therapeutic procedure Clinical Significance Interferes with Clinical Trial | Therapeutic procedure Unstable Interferes with Clinical Trial
Item
history of clinically significant or unstable medical disorder or treatment that would interfere with the study.
boolean
C0012634 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C0008976 (UMLS CUI [1,4])
C0012634 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
C0521102 (UMLS CUI [2,3])
C0008976 (UMLS CUI [2,4])
C0087111 (UMLS CUI [3,1])
C2826293 (UMLS CUI [3,2])
C0521102 (UMLS CUI [3,3])
C0008976 (UMLS CUI [3,4])
C0087111 (UMLS CUI [4,1])
C0443343 (UMLS CUI [4,2])
C0521102 (UMLS CUI [4,3])
C0008976 (UMLS CUI [4,4])
Autistic Disorder | Pervasive Development Disorder | Organic brain disorder | Dementia | Cerebrovascular accident | Epilepsy | Seizures Requirement Therapeutic procedure | Febrile Convulsions | Craniocerebral Trauma
Item
history of autistic disorder or another pervasive developmental disorder, organic brain disease, dementia, stroke, epilepsy or a history of seizures requiring treatment (this does not include febrile seizures as a child), or those who have suffered a traumatic head injury.
boolean
C0004352 (UMLS CUI [1])
C0524528 (UMLS CUI [2])
C4062280 (UMLS CUI [3])
C0497327 (UMLS CUI [4])
C0038454 (UMLS CUI [5])
C0014544 (UMLS CUI [6])
C0036572 (UMLS CUI [7,1])
C1514873 (UMLS CUI [7,2])
C0087111 (UMLS CUI [7,3])
C0009952 (UMLS CUI [8])
C0018674 (UMLS CUI [9])
Psychotropic Drugs | Central Nervous System Agents Primary
Item
taking psychotropic or primarily centrally active medication at screening.
boolean
C0033978 (UMLS CUI [1])
C0007680 (UMLS CUI [2,1])
C0205225 (UMLS CUI [2,2])
Antidepressive Agents | Mood Stabilizer
Item
use of antidepressant medications or mood stabilizers within 1 month of screening.
boolean
C0003289 (UMLS CUI [1])
C2917435 (UMLS CUI [2])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

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