ID

37170

Descripción

Memantine add-on for Cognitive and Negative Symptoms of Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT02001103

Link

https://clinicaltrials.gov/show/NCT02001103

Palabras clave

Versiones (1)
  1. 5/7/19 5/7/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

5 de julio de 2019

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT02001103

Inglés

Eligibility Schizophrenia NCT02001103

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
both male and female outpatients
Descripción

Outpatients

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0029921
age 18-45 years old at the time of screening
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
a diagnosis of schizophrenia based on the structured clinical interview for dsm-iv
Descripción

Schizophrenia

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0036341
currently receiving treatment mainly by an atypical antipsychotic (risperidone, olanzapine, amisulpride, aripiprazole, quetiapine, ziprasidone, paliperidone), including long-acting injectable antipsychotic
Descripción

Atypical antipsychotic | Risperidone | olanzapine | Amisulpride | aripiprazole | quetiapine | ziprasidone | paliperidone | Antipsychotic Agents Injectable Long-term Active

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1276996
UMLS CUI [2]
C0073393
UMLS CUI [3]
C0171023
UMLS CUI [4]
C0103045
UMLS CUI [5]
C0299792
UMLS CUI [6]
C0123091
UMLS CUI [7]
C0380393
UMLS CUI [8]
C0753678
UMLS CUI [9,1]
C0040615
UMLS CUI [9,2]
C0086466
UMLS CUI [9,3]
C0443252
UMLS CUI [9,4]
C0205177
a first generation antipsychotic agent only for a low-dose, as needed use purpose
Descripción

Antipsychotic Agents Generation First Low dose

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0040615
UMLS CUI [1,2]
C0079411
UMLS CUI [1,3]
C0205435
UMLS CUI [1,4]
C0445550
no revised use of benzodiazepines, antidepressants, anticholinergics, or other concomitant medications during past 3 months
Descripción

Benzodiazepines Absent | Antidepressive Agents Absent | Anticholinergic Agents Absent | Concomitant Agent Absent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0005064
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0003289
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0242896
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C2347852
UMLS CUI [4,2]
C0332197
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
a score of 5 or more on any of the 7 positive symptom items of the panss rating at screening
Descripción

PANSS Clinical Classification | Item score Symptom Positive

Tipo de datos

boolean

Alias
UMLS CUI [1]
C4086747
UMLS CUI [2,1]
C0559741
UMLS CUI [2,2]
C1457887
UMLS CUI [2,3]
C1514241
scores of 4 on at least 3 of the 7 positive symptom items of the panss rating at screening
Descripción

PANSS Clinical Classification | Item score Symptom Positive

Tipo de datos

boolean

Alias
UMLS CUI [1]
C4086747
UMLS CUI [2,1]
C0559741
UMLS CUI [2,2]
C1457887
UMLS CUI [2,3]
C1514241
currently under clozapine treatment
Descripción

Clozapine

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0009079
a change of current antipsychotic medication in recent 3 months
Descripción

Antipsychotic Agents Change

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0040615
UMLS CUI [1,2]
C0392747
mental retardation known as iq below 70 prior to the diagnosis of schizophrenia
Descripción

Mental Retardation Intelligence quotient

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0025362
UMLS CUI [1,2]
C0456149
a history of pervasive mental disorder or bipolar disorder
Descripción

Pervasive disorder mental | Bipolar Disorder

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1404993
UMLS CUI [1,2]
C0229992
UMLS CUI [2]
C0005586
a medical condition with significant cognitive sequelae
Descripción

Medical condition Associated with Sequelae Cognitive

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C0243088
UMLS CUI [1,4]
C1516691
a history of substance dependence
Descripción

Substance Dependence

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0038580
a history of hypersensitivity to memantine or other drugs of the same class, such as amantadine
Descripción

Hypersensitivity Memantine | Hypersensitivity Pharmaceutical Preparations Class Same | Amantadine allergy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0025242
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0013227
UMLS CUI [2,3]
C0456387
UMLS CUI [2,4]
C0445247
UMLS CUI [3]
C0570733
pregnancy, plan to get pregnant during the study period, or lactating women
Descripción

Pregnancy | Pregnancy, Planned | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
UMLS CUI [3]
C0006147
abnormal liver function (ast, alt higher than doubling the upper limits of normal range) or abnormal renal function (blood creatinine > 1.3 mg/dl)
Descripción

Liver Dysfunction | Aspartate aminotransferase increased | Alanine aminotransferase increased | Abnormal renal function | Measurement of creatinine in blood

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2]
C0151904
UMLS CUI [3]
C0151905
UMLS CUI [4]
C0151746
UMLS CUI [5]
C3525719
a history of epilepsy
Descripción

Epilepsy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0014544
a history of myocardial infarction, congestive heart failure, uncontrolled hypertension, stroke, or severe heart block.
Descripción

Myocardial Infarction | Congestive heart failure | Uncontrolled hypertension | Cerebrovascular accident | Heart Block Severe

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0018802
UMLS CUI [3]
C1868885
UMLS CUI [4]
C0038454
UMLS CUI [5,1]
C0018794
UMLS CUI [5,2]
C0205082
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Similar models

Eligibility Schizophrenia NCT02001103

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Outpatients
Item
both male and female outpatients
boolean
C0029921 (UMLS CUI [1])
Age
Item
age 18-45 years old at the time of screening
boolean
C0001779 (UMLS CUI [1])
Schizophrenia
Item
a diagnosis of schizophrenia based on the structured clinical interview for dsm-iv
boolean
C0036341 (UMLS CUI [1])
Atypical antipsychotic | Risperidone | olanzapine | Amisulpride | aripiprazole | quetiapine | ziprasidone | paliperidone | Antipsychotic Agents Injectable Long-term Active
Item
currently receiving treatment mainly by an atypical antipsychotic (risperidone, olanzapine, amisulpride, aripiprazole, quetiapine, ziprasidone, paliperidone), including long-acting injectable antipsychotic
boolean
C1276996 (UMLS CUI [1])
C0073393 (UMLS CUI [2])
C0171023 (UMLS CUI [3])
C0103045 (UMLS CUI [4])
C0299792 (UMLS CUI [5])
C0123091 (UMLS CUI [6])
C0380393 (UMLS CUI [7])
C0753678 (UMLS CUI [8])
C0040615 (UMLS CUI [9,1])
C0086466 (UMLS CUI [9,2])
C0443252 (UMLS CUI [9,3])
C0205177 (UMLS CUI [9,4])
Antipsychotic Agents Generation First Low dose
Item
a first generation antipsychotic agent only for a low-dose, as needed use purpose
boolean
C0040615 (UMLS CUI [1,1])
C0079411 (UMLS CUI [1,2])
C0205435 (UMLS CUI [1,3])
C0445550 (UMLS CUI [1,4])
Benzodiazepines Absent | Antidepressive Agents Absent | Anticholinergic Agents Absent | Concomitant Agent Absent
Item
no revised use of benzodiazepines, antidepressants, anticholinergics, or other concomitant medications during past 3 months
boolean
C0005064 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0003289 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0242896 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C2347852 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Item Group
C0680251 (UMLS CUI)
PANSS Clinical Classification | Item score Symptom Positive
Item
a score of 5 or more on any of the 7 positive symptom items of the panss rating at screening
boolean
C4086747 (UMLS CUI [1])
C0559741 (UMLS CUI [2,1])
C1457887 (UMLS CUI [2,2])
C1514241 (UMLS CUI [2,3])
PANSS Clinical Classification | Item score Symptom Positive
Item
scores of 4 on at least 3 of the 7 positive symptom items of the panss rating at screening
boolean
C4086747 (UMLS CUI [1])
C0559741 (UMLS CUI [2,1])
C1457887 (UMLS CUI [2,2])
C1514241 (UMLS CUI [2,3])
Clozapine
Item
currently under clozapine treatment
boolean
C0009079 (UMLS CUI [1])
Antipsychotic Agents Change
Item
a change of current antipsychotic medication in recent 3 months
boolean
C0040615 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
Mental Retardation Intelligence quotient
Item
mental retardation known as iq below 70 prior to the diagnosis of schizophrenia
boolean
C0025362 (UMLS CUI [1,1])
C0456149 (UMLS CUI [1,2])
Pervasive disorder mental | Bipolar Disorder
Item
a history of pervasive mental disorder or bipolar disorder
boolean
C1404993 (UMLS CUI [1,1])
C0229992 (UMLS CUI [1,2])
C0005586 (UMLS CUI [2])
Medical condition Associated with Sequelae Cognitive
Item
a medical condition with significant cognitive sequelae
boolean
C3843040 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0243088 (UMLS CUI [1,3])
C1516691 (UMLS CUI [1,4])
Substance Dependence
Item
a history of substance dependence
boolean
C0038580 (UMLS CUI [1])
Hypersensitivity Memantine | Hypersensitivity Pharmaceutical Preparations Class Same | Amantadine allergy
Item
a history of hypersensitivity to memantine or other drugs of the same class, such as amantadine
boolean
C0020517 (UMLS CUI [1,1])
C0025242 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0456387 (UMLS CUI [2,3])
C0445247 (UMLS CUI [2,4])
C0570733 (UMLS CUI [3])
Pregnancy | Pregnancy, Planned | Breast Feeding
Item
pregnancy, plan to get pregnant during the study period, or lactating women
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
Liver Dysfunction | Aspartate aminotransferase increased | Alanine aminotransferase increased | Abnormal renal function | Measurement of creatinine in blood
Item
abnormal liver function (ast, alt higher than doubling the upper limits of normal range) or abnormal renal function (blood creatinine > 1.3 mg/dl)
boolean
C0086565 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
C0151905 (UMLS CUI [3])
C0151746 (UMLS CUI [4])
C3525719 (UMLS CUI [5])
Epilepsy
Item
a history of epilepsy
boolean
C0014544 (UMLS CUI [1])
Myocardial Infarction | Congestive heart failure | Uncontrolled hypertension | Cerebrovascular accident | Heart Block Severe
Item
a history of myocardial infarction, congestive heart failure, uncontrolled hypertension, stroke, or severe heart block.
boolean
C0027051 (UMLS CUI [1])
C0018802 (UMLS CUI [2])
C1868885 (UMLS CUI [3])
C0038454 (UMLS CUI [4])
C0018794 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
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