ID

19264

Beschrijving

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

Trefwoorden

Versies (3)
  1. 16-12-16 16-12-16 -
  2. 19-04-18 19-04-18 - Sarah Riepenhausen
  3. 20-09-21 20-09-21 -
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16 december 2016

DOI

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Creative Commons BY-NC 3.0
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Eligibility Schizophrenia NCT00086593

Engels

Eligibility Schizophrenia NCT00086593

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosed with schizophrenia.
Beschrijving

Schizophrenia

Datatype

boolean

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

Symptoms Positive persistent

Datatype

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.
Beschrijving

Atypical antipsychotic Specific Quantity

Datatype

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.
Beschrijving

Informed Consent | Informed Consent Legal Guardian

Datatype

boolean

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

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.
Beschrijving

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

Datatype

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.
Beschrijving

Axis I diagnosis predominant | Schizophrenia

Datatype

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.
Beschrijving

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

Datatype

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.
Beschrijving

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

Datatype

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.
Beschrijving

Psychotropic Drugs | Central Nervous System Agents Primary

Datatype

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.
Beschrijving

Antidepressive Agents | Mood Stabilizer

Datatype

boolean

Alias
UMLS CUI [1]
C0003289
UMLS CUI [2]
C2917435
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Similar models

Eligibility Schizophrenia NCT00086593

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
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