ID

23083

Descrição

Effects of Atomoxetine on Cognitive Function in Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT00420498

Link

https://clinicaltrials.gov/show/NCT00420498

Palavras-chave

Versões (1)
  1. 22/06/2017 22/06/2017 -
Transferido a

22 de junho de 2017

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT00420498

Inglês

Eligibility Schizophrenia NCT00420498

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
between ages 18 and 59;
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
scid-i for dsm-iv diagnosis of schizophrenia or schizoaffective disorder, and nicotine dependence
Descrição

Schizophrenia | Schizoaffective Disorder | Nicotine Dependence

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0036341
UMLS CUI [2]
C0036337
UMLS CUI [3]
C0028043
smoking at least 15 cigarettes per day, and have expired breath co level >10 ppm,
Descrição

Tobacco use Number of cigarettes per day | breath test expired carbon monoxide

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0543414
UMLS CUI [1,2]
C3694146
UMLS CUI [2]
C2207180
be in stable remission from active psychiatric symptomatology, (as judged by trained clinical staff in the prism research program) and be on a stable dose of psychiatric medication(s) for the past 3 months
Descrição

Psychiatric symptom | Remission Stable | Pharmaceutical Preparations Psychiatric Dose Stable

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0233401
UMLS CUI [2,1]
C0544452
UMLS CUI [2,2]
C0205360
UMLS CUI [3,1]
C0013227
UMLS CUI [3,2]
C0205487
UMLS CUI [3,3]
C0178602
UMLS CUI [3,4]
C0205360
no current abuse or dependence of alcohol or other substances of abuse within the past 3 months,
Descrição

Substance Use Disorders Absent | Substance Dependence Absent

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0038586
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0038580
UMLS CUI [2,2]
C0332197
full scale iq > 80,
Descrição

Intelligence quotient

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0456149
presence of definable cognitive deficits of interest including vswm, cpt, and wcst (e.g. at least one standard deviation below average).
Descrição

Cognition Disorders | Visuospatial memory deficit | Wisconsin card sorting test

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0009241
UMLS CUI [2]
C4228414
UMLS CUI [3]
C0451592
able to give informed consent for participation.
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
meet dsm-iv criteria for other major axis i disorders besides those specified for each diagnostic group.
Descrição

Axis I diagnosis Major

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0270287
UMLS CUI [1,2]
C0205164
current abuse or dependence of alcohol or substances within the last 3 months, and subjects who are methadone maintained will be excluded.
Descrição

Substance Use Disorders | Substance Dependence | Methadone maintenance

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0038580
UMLS CUI [3]
C0588202
full scale iq < 80.
Descrição

Intelligence quotient

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0456149
unable to give informed consent.
Descrição

Informed Consent Unable

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
patients who are pregnant or planning on becoming pregnant will not be included in this study.
Descrição

Pregnancy | Pregnancy, Planned

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
patients on paroxetine, fluoxetine, and quinidine will be excluded from this study.
Descrição

Paroxetine | Fluoxetine | Quinidine

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0070122
UMLS CUI [2]
C0016365
UMLS CUI [3]
C0034414
are deemed medically unsafe to take atomoxetine, as judged by the study physician. contraindications to the use of atomoxetine include hypersensitivity to atomoxetine, concurrent use of monoamine oxidase inhibitors (atomoxetine should be avoided during therapy with or within 2 weeks of discontinuing an mao inhibitor), and patients with narrow angle glaucoma. precautions would include concomitant administration with cyp 2d6 inhibitors (eg, paroxetine, fluoxetine, quinidine) (which would necessitate a dose adjustment with atomoxetine), liver disease (enhanced risk of toxicity; empiric dose reduction is suggested based on clinical response; the drug should be avoided in acute hepatic failure), patients with hypertension, tachycardia, or other cardiovascular or cerebrovascular disease, patients with or at risk of hypotension , patients with urinary retention or bladder dysfunction.
Descrição

Medical contraindication atomoxetine | Hypersensitivity atomoxetine | Monoamine Oxidase Inhibitors | Angle Closure Glaucoma | Cytochrome P-450 CYP2D6 inhibitors | Paroxetine | Fluoxetine | Quinidine | Liver diseases | Risk Toxicity | Liver Failure | Hypertensive disease | Tachycardia | Cardiovascular Diseases | Cerebrovascular Disorders | Hypotension | Risk Hypotension | Urinary Retention | Bladder dysfunction

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0076823
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0076823
UMLS CUI [3]
C0026457
UMLS CUI [4]
C0017605
UMLS CUI [5,1]
C0057223
UMLS CUI [5,2]
C0243077
UMLS CUI [6]
C0070122
UMLS CUI [7]
C0016365
UMLS CUI [8]
C0034414
UMLS CUI [9]
C0023895
UMLS CUI [10,1]
C0035647
UMLS CUI [10,2]
C0600688
UMLS CUI [11]
C0085605
UMLS CUI [12]
C0020538
UMLS CUI [13]
C0039231
UMLS CUI [14]
C0007222
UMLS CUI [15]
C0007820
UMLS CUI [16]
C0020649
UMLS CUI [17,1]
C0035647
UMLS CUI [17,2]
C0020649
UMLS CUI [18]
C0080274
UMLS CUI [19]
C0232841
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Similar models

Eligibility Schizophrenia NCT00420498

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
between ages 18 and 59;
boolean
C0001779 (UMLS CUI [1])
Schizophrenia | Schizoaffective Disorder | Nicotine Dependence
Item
scid-i for dsm-iv diagnosis of schizophrenia or schizoaffective disorder, and nicotine dependence
boolean
C0036341 (UMLS CUI [1])
C0036337 (UMLS CUI [2])
C0028043 (UMLS CUI [3])
Tobacco use Number of cigarettes per day | breath test expired carbon monoxide
Item
smoking at least 15 cigarettes per day, and have expired breath co level >10 ppm,
boolean
C0543414 (UMLS CUI [1,1])
C3694146 (UMLS CUI [1,2])
C2207180 (UMLS CUI [2])
Psychiatric symptom | Remission Stable | Pharmaceutical Preparations Psychiatric Dose Stable
Item
be in stable remission from active psychiatric symptomatology, (as judged by trained clinical staff in the prism research program) and be on a stable dose of psychiatric medication(s) for the past 3 months
boolean
C0233401 (UMLS CUI [1])
C0544452 (UMLS CUI [2,1])
C0205360 (UMLS CUI [2,2])
C0013227 (UMLS CUI [3,1])
C0205487 (UMLS CUI [3,2])
C0178602 (UMLS CUI [3,3])
C0205360 (UMLS CUI [3,4])
Substance Use Disorders Absent | Substance Dependence Absent
Item
no current abuse or dependence of alcohol or other substances of abuse within the past 3 months,
boolean
C0038586 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0038580 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Intelligence quotient
Item
full scale iq > 80,
boolean
C0456149 (UMLS CUI [1])
Cognition Disorders | Visuospatial memory deficit | Wisconsin card sorting test
Item
presence of definable cognitive deficits of interest including vswm, cpt, and wcst (e.g. at least one standard deviation below average).
boolean
C0009241 (UMLS CUI [1])
C4228414 (UMLS CUI [2])
C0451592 (UMLS CUI [3])
Informed Consent
Item
able to give informed consent for participation.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Axis I diagnosis Major
Item
meet dsm-iv criteria for other major axis i disorders besides those specified for each diagnostic group.
boolean
C0270287 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
Substance Use Disorders | Substance Dependence | Methadone maintenance
Item
current abuse or dependence of alcohol or substances within the last 3 months, and subjects who are methadone maintained will be excluded.
boolean
C0038586 (UMLS CUI [1])
C0038580 (UMLS CUI [2])
C0588202 (UMLS CUI [3])
Intelligence quotient
Item
full scale iq < 80.
boolean
C0456149 (UMLS CUI [1])
Informed Consent Unable
Item
unable to give informed consent.
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Pregnancy | Pregnancy, Planned
Item
patients who are pregnant or planning on becoming pregnant will not be included in this study.
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
Paroxetine | Fluoxetine | Quinidine
Item
patients on paroxetine, fluoxetine, and quinidine will be excluded from this study.
boolean
C0070122 (UMLS CUI [1])
C0016365 (UMLS CUI [2])
C0034414 (UMLS CUI [3])
Medical contraindication atomoxetine | Hypersensitivity atomoxetine | Monoamine Oxidase Inhibitors | Angle Closure Glaucoma | Cytochrome P-450 CYP2D6 inhibitors | Paroxetine | Fluoxetine | Quinidine | Liver diseases | Risk Toxicity | Liver Failure | Hypertensive disease | Tachycardia | Cardiovascular Diseases | Cerebrovascular Disorders | Hypotension | Risk Hypotension | Urinary Retention | Bladder dysfunction
Item
are deemed medically unsafe to take atomoxetine, as judged by the study physician. contraindications to the use of atomoxetine include hypersensitivity to atomoxetine, concurrent use of monoamine oxidase inhibitors (atomoxetine should be avoided during therapy with or within 2 weeks of discontinuing an mao inhibitor), and patients with narrow angle glaucoma. precautions would include concomitant administration with cyp 2d6 inhibitors (eg, paroxetine, fluoxetine, quinidine) (which would necessitate a dose adjustment with atomoxetine), liver disease (enhanced risk of toxicity; empiric dose reduction is suggested based on clinical response; the drug should be avoided in acute hepatic failure), patients with hypertension, tachycardia, or other cardiovascular or cerebrovascular disease, patients with or at risk of hypotension , patients with urinary retention or bladder dysfunction.
boolean
C1301624 (UMLS CUI [1,1])
C0076823 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0076823 (UMLS CUI [2,2])
C0026457 (UMLS CUI [3])
C0017605 (UMLS CUI [4])
C0057223 (UMLS CUI [5,1])
C0243077 (UMLS CUI [5,2])
C0070122 (UMLS CUI [6])
C0016365 (UMLS CUI [7])
C0034414 (UMLS CUI [8])
C0023895 (UMLS CUI [9])
C0035647 (UMLS CUI [10,1])
C0600688 (UMLS CUI [10,2])
C0085605 (UMLS CUI [11])
C0020538 (UMLS CUI [12])
C0039231 (UMLS CUI [13])
C0007222 (UMLS CUI [14])
C0007820 (UMLS CUI [15])
C0020649 (UMLS CUI [16])
C0035647 (UMLS CUI [17,1])
C0020649 (UMLS CUI [17,2])
C0080274 (UMLS CUI [18])
C0232841 (UMLS CUI [19])
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