ID

15971

Descripción

Adjunctive Vortioxetine in Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT02357797

Link

https://clinicaltrials.gov/show/NCT02357797

Palabras clave

Versiones (1)
  1. 22/6/16 22/6/16 -
Subido en

22 de junio de 2016

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT02357797

Inglés

Eligibility Schizophrenia NCT02357797

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. outpatient
Descripción

Outpatient

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0029921
2. scid diagnosis of schizophrenia
Descripción

Schizophrenia

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0036341
3. age 18-65 years old
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
4. treated with an adequate dose of one or a maximum of two antipsychotic medications for at least 3 months, with a stable dose for at least the last 4 weeks, and willing to continue for up to 16 weeks.
Descripción

Antipsychotic Agents | Dosage Adequate | Dosage Stable

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0040615
UMLS CUI [2,1]
C0178602
UMLS CUI [2,2]
C0205411
UMLS CUI [3,1]
C0178602
UMLS CUI [3,2]
C0205360
5. no antidepressant treatment for at least 8 weeks prior to randomization.
Descripción

Antidepressant therapy Absent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1096649
UMLS CUI [1,2]
C0332197
6. treatment with other concomitant, non-antipsychotic, psychiatric medications is allowed, but must be unchanged for at least 8 weeks, with a stable dose for at least the last 4 weeks, and willing to continue for 16 weeks. benzodiazepines must not be given within 8 hours of the cognitive assessment. treatment with non-psychiatric medications is unrestricted.
Descripción

Pharmaceutical Preparations psychiatric concomitant | Benzodiazepines | Assessment: Cognition

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0205487
UMLS CUI [1,3]
C0521115
UMLS CUI [2]
C0005064
UMLS CUI [3]
C0870300
7. panss negative subscore >14 with at least two of the items at a level >/=4 (moderate)
Descripción

Positive and negative syndrome scale Negative | Level Moderate

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0451383
UMLS CUI [1,2]
C0205160
UMLS CUI [2,1]
C0441889
UMLS CUI [2,2]
C0205081
8. panss positive subscore </=14 with not more than one of the items at a level >/=4 (moderate)
Descripción

Positive and negative syndrome scale Positive | Level Moderate

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0451383
UMLS CUI [1,2]
C1446409
UMLS CUI [2,1]
C0441889
UMLS CUI [2,2]
C0205081
9. hamd-17 total score </=12
Descripción

HAMD-17 - Total Score

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3639399
10. simpson angus score of any item <3
Descripción

ID.10

Tipo de datos

boolean

11. english-speaking
Descripción

Able to speak English Language

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0564215
UMLS CUI [1,2]
C0376245
12. competent and willing to sign informed consent
Descripción

Informed consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. structural brain disease
Descripción

Structural brain disorder

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0851391
2. mental retardation by history and estimated iq <70 (wrat-iii word reading)
Descripción

Mental Retardation | Intelligence quotient

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0025362
UMLS CUI [2]
C0456149
3. autism-spectrum disorder diagnosis by history
Descripción

Autism Spectrum Disorder

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1510586
4. any serious chronic medical illnesses that in the view of the investigator will interfere with the patient's ability to comply with the study procedures or that will interfere with cognition.
Descripción

Chronic disease Interferes with Compliance behavior Study Protocol | Chronic disease Interferes with Cognition

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0008679
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C1321605
UMLS CUI [1,4]
C2348563
UMLS CUI [2,1]
C0008679
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0009240
5. active substance abuse or dependence in the past 8 weeks
Descripción

Substance Use Disorders | Substance Dependence

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0038580
6. intolerance to or inefficacy of vortioxetine in the past
Descripción

intolerance to vortioxetine | vortioxetine ineffective

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C3661282
UMLS CUI [2,1]
C3661282
UMLS CUI [2,2]
C3242229
7. acute anger to self or others as per investigator assessment
Descripción

Persistent anger with self or others

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1718201
8. pregnant or breastfeeding females
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
9. unwilling or unable to be sexually abstinent or not using an effective form of birth control if they are sexually active
Descripción

Sexual Abstinence Unwilling | Sexual Abstinence Unable | Contraceptive methods Not used

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0036899
UMLS CUI [1,2]
C0558080
UMLS CUI [2,1]
C0036899
UMLS CUI [2,2]
C1299582
UMLS CUI [3,1]
C0700589
UMLS CUI [3,2]
C0445107
10. current treatment with a monoamine oxidase inhibitor (maoi)
Descripción

Therapeutic procedure Monoamine Oxidase Inhibitor

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0026457
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Similar models

Eligibility Schizophrenia NCT02357797

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Outpatient
Item
1. outpatient
boolean
C0029921 (UMLS CUI [1])
Schizophrenia
Item
2. scid diagnosis of schizophrenia
boolean
C0036341 (UMLS CUI [1])
Age
Item
3. age 18-65 years old
boolean
C0001779 (UMLS CUI [1])
Antipsychotic Agents | Dosage Adequate | Dosage Stable
Item
4. treated with an adequate dose of one or a maximum of two antipsychotic medications for at least 3 months, with a stable dose for at least the last 4 weeks, and willing to continue for up to 16 weeks.
boolean
C0040615 (UMLS CUI [1])
C0178602 (UMLS CUI [2,1])
C0205411 (UMLS CUI [2,2])
C0178602 (UMLS CUI [3,1])
C0205360 (UMLS CUI [3,2])
Antidepressant therapy Absent
Item
5. no antidepressant treatment for at least 8 weeks prior to randomization.
boolean
C1096649 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Pharmaceutical Preparations psychiatric concomitant | Benzodiazepines | Assessment: Cognition
Item
6. treatment with other concomitant, non-antipsychotic, psychiatric medications is allowed, but must be unchanged for at least 8 weeks, with a stable dose for at least the last 4 weeks, and willing to continue for 16 weeks. benzodiazepines must not be given within 8 hours of the cognitive assessment. treatment with non-psychiatric medications is unrestricted.
boolean
C0013227 (UMLS CUI [1,1])
C0205487 (UMLS CUI [1,2])
C0521115 (UMLS CUI [1,3])
C0005064 (UMLS CUI [2])
C0870300 (UMLS CUI [3])
Positive and negative syndrome scale Negative | Level Moderate
Item
7. panss negative subscore >14 with at least two of the items at a level >/=4 (moderate)
boolean
C0451383 (UMLS CUI [1,1])
C0205160 (UMLS CUI [1,2])
C0441889 (UMLS CUI [2,1])
C0205081 (UMLS CUI [2,2])
Positive and negative syndrome scale Positive | Level Moderate
Item
8. panss positive subscore </=14 with not more than one of the items at a level >/=4 (moderate)
boolean
C0451383 (UMLS CUI [1,1])
C1446409 (UMLS CUI [1,2])
C0441889 (UMLS CUI [2,1])
C0205081 (UMLS CUI [2,2])
HAMD-17 - Total Score
Item
9. hamd-17 total score </=12
boolean
C3639399 (UMLS CUI [1])
ID.10
Item
10. simpson angus score of any item <3
boolean
Able to speak English Language
Item
11. english-speaking
boolean
C0564215 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
Informed consent
Item
12. competent and willing to sign informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Structural brain disorder
Item
1. structural brain disease
boolean
C0851391 (UMLS CUI [1])
Mental Retardation | Intelligence quotient
Item
2. mental retardation by history and estimated iq <70 (wrat-iii word reading)
boolean
C0025362 (UMLS CUI [1])
C0456149 (UMLS CUI [2])
Autism Spectrum Disorder
Item
3. autism-spectrum disorder diagnosis by history
boolean
C1510586 (UMLS CUI [1])
Chronic disease Interferes with Compliance behavior Study Protocol | Chronic disease Interferes with Cognition
Item
4. any serious chronic medical illnesses that in the view of the investigator will interfere with the patient's ability to comply with the study procedures or that will interfere with cognition.
boolean
C0008679 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C1321605 (UMLS CUI [1,3])
C2348563 (UMLS CUI [1,4])
C0008679 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0009240 (UMLS CUI [2,3])
Substance Use Disorders | Substance Dependence
Item
5. active substance abuse or dependence in the past 8 weeks
boolean
C0038586 (UMLS CUI [1])
C0038580 (UMLS CUI [2])
intolerance to vortioxetine | vortioxetine ineffective
Item
6. intolerance to or inefficacy of vortioxetine in the past
boolean
C1744706 (UMLS CUI [1,1])
C3661282 (UMLS CUI [1,2])
C3661282 (UMLS CUI [2,1])
C3242229 (UMLS CUI [2,2])
Persistent anger with self or others
Item
7. acute anger to self or others as per investigator assessment
boolean
C1718201 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
8. pregnant or breastfeeding females
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Sexual Abstinence Unwilling | Sexual Abstinence Unable | Contraceptive methods Not used
Item
9. unwilling or unable to be sexually abstinent or not using an effective form of birth control if they are sexually active
boolean
C0036899 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0036899 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
C0700589 (UMLS CUI [3,1])
C0445107 (UMLS CUI [3,2])
Therapeutic procedure Monoamine Oxidase Inhibitor
Item
10. current treatment with a monoamine oxidase inhibitor (maoi)
boolean
C0087111 (UMLS CUI [1,1])
C0026457 (UMLS CUI [1,2])
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