ID

32014

Beschrijving

Rasagiline in the Treatment of Persistent Negative Symptoms of Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT00492336

Link

https://clinicaltrials.gov/show/NCT00492336

Trefwoorden

Versies (2)
  1. 12-10-18 12-10-18 -
  2. 13-10-18 13-10-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

12 oktober 2018

DOI

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Licentie

Creative Commons BY-NC 3.0
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Eligibility Schizophrenia NCT00492336

Engels

Eligibility Schizophrenia NCT00492336

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects will meet dsm-iv criteria for schizophrenia or schizoaffective disorder.
Beschrijving

Schizophrenia | Schizoaffective Disorder

Datatype

boolean

Alias
UMLS CUI [1]
C0036341
UMLS CUI [2]
C0036337
current treatment with one or more second generation antipsychotics, except ziprasidone
Beschrijving

Antipsychotic Agents Generation second Quantity | Exception Ziprasidone

Datatype

boolean

Alias
UMLS CUI [1,1]
C0040615
UMLS CUI [1,2]
C0079411
UMLS CUI [1,3]
C0205436
UMLS CUI [1,4]
C1265611
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0380393
on same second generation antipsychotic(s)for at least 56 days
Beschrijving

Antipsychotic Agents Same Generation second

Datatype

boolean

Alias
UMLS CUI [1,1]
C0040615
UMLS CUI [1,2]
C0445247
UMLS CUI [1,3]
C0079411
UMLS CUI [1,4]
C0205436
on same dose of second generation antipsychotic(s)for at least 30 days
Beschrijving

Antipsychotic Agents Dose Same | Antipsychotic Agents Generation second

Datatype

boolean

Alias
UMLS CUI [1,1]
C0040615
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0445247
UMLS CUI [2,1]
C0040615
UMLS CUI [2,2]
C0079411
UMLS CUI [2,3]
C0205436
22-item sans: total score (i.e.all items minus global items and poverty of content of speech)greater than 20 or global rating of affective flattening greater than or equal to 3 or global rating of alogia greater than or equal to 3
Beschrijving

Rating scale Schizophrenia | Symptoms Negative | Poverty of speech | Affective blunting | Alogia

Datatype

boolean

Alias
UMLS CUI [1,1]
C0681889
UMLS CUI [1,2]
C0036341
UMLS CUI [2,1]
C0683368
UMLS CUI [2,2]
C1513916
UMLS CUI [3]
C0233720
UMLS CUI [4]
C0860608
UMLS CUI [5]
C0003537
bprs: sum of the four positive symptom items less than or equal to 16 (items 4,11,12,15)
Beschrijving

Brief Psychiatric Rating Scale Symptoms Positive

Datatype

boolean

Alias
UMLS CUI [1,1]
C0029941
UMLS CUI [1,2]
C0683368
UMLS CUI [1,3]
C1514241
bprs: sum of the four anxiety/depression factor items less than or equal to 14 (items 1,2,5,9)
Beschrijving

Brief Psychiatric Rating Scale | BPRS-A - Anxiety | BPRS-A - Depressive Mood

Datatype

boolean

Alias
UMLS CUI [1]
C0029941
UMLS CUI [2]
C3639357
UMLS CUI [3]
C3639364
simpson-angus scale: total score less than or equal to 8
Beschrijving

Rating scale Extrapyramidal Disorders

Datatype

boolean

Alias
UMLS CUI [1,1]
C0681889
UMLS CUI [1,2]
C0015371
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
dsm-iv major depressive disorder within last 6 months
Beschrijving

Major Depressive Disorder

Datatype

boolean

Alias
UMLS CUI [1]
C1269683
current treatment with ziprasidone
Beschrijving

ziprasidone

Datatype

boolean

Alias
UMLS CUI [1]
C0380393
dsm-iv diagnosis of alcohol or substance dependence within the last 6 months
Beschrijving

Substance Dependence

Datatype

boolean

Alias
UMLS CUI [1]
C0038580
dsm-iv criteria for alcohol or substance abuse within the last month
Beschrijving

Substance Use Disorders

Datatype

boolean

Alias
UMLS CUI [1]
C0038586
evidence of illicit substance use, as identified with urine toxicology screen
Beschrijving

Illicit substance use Urine Toxicology screen

Datatype

boolean

Alias
UMLS CUI [1,1]
C0281875
UMLS CUI [1,2]
C0042036
UMLS CUI [1,3]
C0430054
history of an organic brain disorder, mental retardation,epilepsy, or a medical condition, whose pathology or treatment could alter the presentation or treatment of schizophrenia or significantly increase the risk associated with the proposed treatment protocol. see those listed below
Beschrijving

Organic brain disorder | Mental Retardation | Epilepsy | Medical condition Affecting Schizophrenia | Medical condition Study Protocol At risk

Datatype

boolean

Alias
UMLS CUI [1]
C4062280
UMLS CUI [2]
C0025362
UMLS CUI [3]
C0014544
UMLS CUI [4,1]
C3843040
UMLS CUI [4,2]
C0392760
UMLS CUI [4,3]
C0036341
UMLS CUI [5,1]
C3843040
UMLS CUI [5,2]
C2348563
UMLS CUI [5,3]
C1444641
uncontrolled hypertension defined as bp exceeding 145/90 on 3 consecutive readings despite adequate treatment, pheochromocytoma, melanoma, hepatic insufficiency
Beschrijving

Uncontrolled hypertension | Blood pressure determination Quantity | Therapy Adequate | Pheochromocytoma | Melanoma | Hepatic Insufficiency

Datatype

boolean

Alias
UMLS CUI [1]
C1868885
UMLS CUI [2,1]
C0005824
UMLS CUI [2,2]
C1265611
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C0205411
UMLS CUI [4]
C0031511
UMLS CUI [5]
C0025202
UMLS CUI [6]
C1306571
pregnancy or lactation in females
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
pheochromocytoma
Beschrijving

Pheochromocytoma

Datatype

boolean

Alias
UMLS CUI [1]
C0031511
melanoma
Beschrijving

Melanoma

Datatype

boolean

Alias
UMLS CUI [1]
C0025202
hepatic insufficiency
Beschrijving

Hepatic Insufficiency

Datatype

boolean

Alias
UMLS CUI [1]
C1306571
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Similar models

Eligibility Schizophrenia NCT00492336

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Schizophrenia | Schizoaffective Disorder
Item
subjects will meet dsm-iv criteria for schizophrenia or schizoaffective disorder.
boolean
C0036341 (UMLS CUI [1])
C0036337 (UMLS CUI [2])
Antipsychotic Agents Generation second Quantity | Exception Ziprasidone
Item
current treatment with one or more second generation antipsychotics, except ziprasidone
boolean
C0040615 (UMLS CUI [1,1])
C0079411 (UMLS CUI [1,2])
C0205436 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
C1705847 (UMLS CUI [2,1])
C0380393 (UMLS CUI [2,2])
Antipsychotic Agents Same Generation second
Item
on same second generation antipsychotic(s)for at least 56 days
boolean
C0040615 (UMLS CUI [1,1])
C0445247 (UMLS CUI [1,2])
C0079411 (UMLS CUI [1,3])
C0205436 (UMLS CUI [1,4])
Antipsychotic Agents Dose Same | Antipsychotic Agents Generation second
Item
on same dose of second generation antipsychotic(s)for at least 30 days
boolean
C0040615 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0445247 (UMLS CUI [1,3])
C0040615 (UMLS CUI [2,1])
C0079411 (UMLS CUI [2,2])
C0205436 (UMLS CUI [2,3])
Rating scale Schizophrenia | Symptoms Negative | Poverty of speech | Affective blunting | Alogia
Item
22-item sans: total score (i.e.all items minus global items and poverty of content of speech)greater than 20 or global rating of affective flattening greater than or equal to 3 or global rating of alogia greater than or equal to 3
boolean
C0681889 (UMLS CUI [1,1])
C0036341 (UMLS CUI [1,2])
C0683368 (UMLS CUI [2,1])
C1513916 (UMLS CUI [2,2])
C0233720 (UMLS CUI [3])
C0860608 (UMLS CUI [4])
C0003537 (UMLS CUI [5])
Brief Psychiatric Rating Scale Symptoms Positive
Item
bprs: sum of the four positive symptom items less than or equal to 16 (items 4,11,12,15)
boolean
C0029941 (UMLS CUI [1,1])
C0683368 (UMLS CUI [1,2])
C1514241 (UMLS CUI [1,3])
Brief Psychiatric Rating Scale | BPRS-A - Anxiety | BPRS-A - Depressive Mood
Item
bprs: sum of the four anxiety/depression factor items less than or equal to 14 (items 1,2,5,9)
boolean
C0029941 (UMLS CUI [1])
C3639357 (UMLS CUI [2])
C3639364 (UMLS CUI [3])
Rating scale Extrapyramidal Disorders
Item
simpson-angus scale: total score less than or equal to 8
boolean
C0681889 (UMLS CUI [1,1])
C0015371 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Major Depressive Disorder
Item
dsm-iv major depressive disorder within last 6 months
boolean
C1269683 (UMLS CUI [1])
ziprasidone
Item
current treatment with ziprasidone
boolean
C0380393 (UMLS CUI [1])
Substance Dependence
Item
dsm-iv diagnosis of alcohol or substance dependence within the last 6 months
boolean
C0038580 (UMLS CUI [1])
Substance Use Disorders
Item
dsm-iv criteria for alcohol or substance abuse within the last month
boolean
C0038586 (UMLS CUI [1])
Illicit substance use Urine Toxicology screen
Item
evidence of illicit substance use, as identified with urine toxicology screen
boolean
C0281875 (UMLS CUI [1,1])
C0042036 (UMLS CUI [1,2])
C0430054 (UMLS CUI [1,3])
Organic brain disorder | Mental Retardation | Epilepsy | Medical condition Affecting Schizophrenia | Medical condition Study Protocol At risk
Item
history of an organic brain disorder, mental retardation,epilepsy, or a medical condition, whose pathology or treatment could alter the presentation or treatment of schizophrenia or significantly increase the risk associated with the proposed treatment protocol. see those listed below
boolean
C4062280 (UMLS CUI [1])
C0025362 (UMLS CUI [2])
C0014544 (UMLS CUI [3])
C3843040 (UMLS CUI [4,1])
C0392760 (UMLS CUI [4,2])
C0036341 (UMLS CUI [4,3])
C3843040 (UMLS CUI [5,1])
C2348563 (UMLS CUI [5,2])
C1444641 (UMLS CUI [5,3])
Uncontrolled hypertension | Blood pressure determination Quantity | Therapy Adequate | Pheochromocytoma | Melanoma | Hepatic Insufficiency
Item
uncontrolled hypertension defined as bp exceeding 145/90 on 3 consecutive readings despite adequate treatment, pheochromocytoma, melanoma, hepatic insufficiency
boolean
C1868885 (UMLS CUI [1])
C0005824 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0087111 (UMLS CUI [3,1])
C0205411 (UMLS CUI [3,2])
C0031511 (UMLS CUI [4])
C0025202 (UMLS CUI [5])
C1306571 (UMLS CUI [6])
Pregnancy | Breast Feeding
Item
pregnancy or lactation in females
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Pheochromocytoma
Item
pheochromocytoma
boolean
C0031511 (UMLS CUI [1])
Melanoma
Item
melanoma
boolean
C0025202 (UMLS CUI [1])
Hepatic Insufficiency
Item
hepatic insufficiency
boolean
C1306571 (UMLS CUI [1])
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