ID

18799

Description

SAM-e for the Treatment of Depression in Patients With Parkinson's Disease; ODM derived from: https://clinicaltrials.gov/show/NCT00070941

Lien

https://clinicaltrials.gov/show/NCT00070941

Mots-clés

Versions (1)
  1. 21/11/2016 21/11/2016 -
Téléchargé le

21 novembre 2016

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Parkinson's Disease NCT00070941

Anglais

Eligibility Parkinson's Disease NCT00070941

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
idiopathic parkinson's disease as indicated by the presence of at least two of the following signs: resting tremor, rigidity, bradykinesia, or postural reflex impairment
Description

Parkinson Disease Signs | Resting Tremor | Rigidity | Bradykinesia | Postural reflex impairment

Type de données

boolean

Alias
UMLS CUI [1,1]
C0030567
UMLS CUI [1,2]
C0311392
UMLS CUI [2]
C0234379
UMLS CUI [3]
C0026837
UMLS CUI [4]
C0233565
UMLS CUI [5]
C1868839
stable anti-parkinson medication regimen, with no change in medications in the 4 weeks prior to study entry
Description

Antiparkinson Agents Stable | Pharmaceutical Preparations unchanged

Type de données

boolean

Alias
UMLS CUI [1,1]
C0003405
UMLS CUI [1,2]
C0205360
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0442739
no antidepressant or antipsychotic medications within 30 days prior to study entry
Description

Antidepressive Agents | Antipsychotic Agents

Type de données

boolean

Alias
UMLS CUI [1]
C0003289
UMLS CUI [2]
C0040615
agree not to start other pharmacotherapy, psychotherapy, or behavior therapy while participating in the trial
Description

Pharmacotherapy | Psychotherapy | Behavior Therapy | Study Subject Participation Status

Type de données

boolean

Alias
UMLS CUI [1]
C0013216
UMLS CUI [2]
C0033968
UMLS CUI [3]
C0004933
UMLS CUI [4]
C2348568
acceptable methods of contraception
Description

Contraceptive methods Acceptable

Type de données

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C1879533
ability to read and/or follow written and oral instructions presented in english
Description

Able to read Instructions written English Language | Instructions Oral English Language Compliance Ability

Type de données

boolean

Alias
UMLS CUI [1,1]
C0586740
UMLS CUI [1,2]
C1442085
UMLS CUI [1,3]
C1576874
UMLS CUI [1,4]
C0376245
UMLS CUI [2,1]
C1442085
UMLS CUI [2,2]
C0442027
UMLS CUI [2,3]
C0376245
UMLS CUI [2,4]
C3714738
UMLS CUI [2,5]
C0085732
sufficient cognitive ability (baseline mini-mental status > 24) to provide informed consent
Description

Cognitive status Sufficient Informed Consent Related | Mini-mental state examination

Type de données

boolean

Alias
UMLS CUI [1,1]
C0945985
UMLS CUI [1,2]
C0205410
UMLS CUI [1,3]
C0021430
UMLS CUI [1,4]
C0439849
UMLS CUI [2]
C0451306
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of cardiac, hepatic, renal, hematologic, respiratory, endocrine, vascular, metabolic, or other systems abnormalities that are clinically relevant in the opinion of study officials
Description

Heart Diseases | Liver diseases | Kidney Diseases | Hematological Disease | Respiration Disorders | Endocrine System Diseases | Vascular Diseases | Metabolic Diseases | System Abnormality Relevant Clinical

Type de données

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2]
C0023895
UMLS CUI [3]
C0022658
UMLS CUI [4]
C0018939
UMLS CUI [5]
C0035204
UMLS CUI [6]
C0014130
UMLS CUI [7]
C0042373
UMLS CUI [8]
C0025517
UMLS CUI [9,1]
C0449913
UMLS CUI [9,2]
C1704258
UMLS CUI [9,3]
C2347946
UMLS CUI [9,4]
C0205210
certain abnormal laboratory values
Description

Laboratory test result abnormal

Type de données

boolean

Alias
UMLS CUI [1]
C0438215
pregnant or breastfeeding
Description

Pregnancy | Breast Feeding

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
use of an investigational drug within 3 months of study entry
Description

Investigational New Drugs

Type de données

boolean

Alias
UMLS CUI [1]
C0013230
use of st. john's wort or any other "natural" product known to have mood enhancing properties in the 30 days prior to study entry
Description

ST. JOHN'S WORT EXTRACT | Natural Products Mood Enhancement

Type de données

boolean

Alias
UMLS CUI [1]
C0813171
UMLS CUI [2,1]
C1566558
UMLS CUI [2,2]
C0026516
UMLS CUI [2,3]
C2349975
selegiline or other monoamine oxidase inhibitor within the 6 weeks prior to study entry
Description

Selegiline | Monoamine Oxidase Inhibitors

Type de données

boolean

Alias
UMLS CUI [1]
C0036579
UMLS CUI [2]
C0026457
regular usage of anti-anxiety medications or habitual use of sleep medications, although occasional use of certain hypnotics (temazepam, melatonin, or zolpidem) is allowed
Description

Anti-Anxiety Agents Use Regular | taking medication to help sleep Habitual | Narcotics Use Infrequent | Temazepam | Melatonin | zolpidem

Type de données

boolean

Alias
UMLS CUI [1,1]
C0040616
UMLS CUI [1,2]
C1524063
UMLS CUI [1,3]
C0205272
UMLS CUI [2,1]
C2054158
UMLS CUI [2,2]
C0205353
UMLS CUI [3,1]
C0027415
UMLS CUI [3,2]
C1524063
UMLS CUI [3,3]
C0521114
UMLS CUI [4]
C0039468
UMLS CUI [5]
C0025219
UMLS CUI [6]
C0078839
psychotherapy initiated in the 6 months prior to study entry
Description

Psychotherapy Initiation

Type de données

boolean

Alias
UMLS CUI [1,1]
C0033968
UMLS CUI [1,2]
C1704686
history of bipolar disorder, hypomania, mania, schizophrenia, or other psychotic disorder
Description

Bipolar Disorder | Hypomania | Mania | Schizophrenia | Psychotic Disorders

Type de données

boolean

Alias
UMLS CUI [1]
C0005586
UMLS CUI [2]
C0241934
UMLS CUI [3]
C0338831
UMLS CUI [4]
C0036341
UMLS CUI [5]
C0033975
serious suicidal attempt in the 12 months prior to study entry or serious suicidal tendencies/potential
Description

Suicide attempt Serious | Suicidal tendency Serious | Potential Suicidal Serious

Type de données

boolean

Alias
UMLS CUI [1,1]
C0038663
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C0235196
UMLS CUI [2,2]
C0205404
UMLS CUI [3,1]
C3245505
UMLS CUI [3,2]
C0438696
UMLS CUI [3,3]
C0205404
use of dopamine receptor antagonist (metoclopramide, haloperidol)
Description

Dopamine Antagonists | Metoclopramide | Haloperidol

Type de données

boolean

Alias
UMLS CUI [1]
C0242702
UMLS CUI [2]
C0025853
UMLS CUI [3]
C0018546
secondary parkinsonian symptoms due to drugs (including dopamine receptor antagonists), metabolic disorders, cerebrovascular disease, encephalitis, or other degenerative diseases
Description

Parkinsonian Disorders Secondary Due to Pharmaceutical Preparations | Dopamine Antagonists | Metabolic Diseases | Cerebrovascular Disorders | Encephalitis | Degenerative disorder

Type de données

boolean

Alias
UMLS CUI [1,1]
C0242422
UMLS CUI [1,2]
C0175668
UMLS CUI [1,3]
C0678226
UMLS CUI [1,4]
C0013227
UMLS CUI [2]
C0242702
UMLS CUI [3]
C0025517
UMLS CUI [4]
C0007820
UMLS CUI [5]
C0014038
UMLS CUI [6]
C1285162
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Similar models

Eligibility Parkinson's Disease NCT00070941

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Parkinson Disease Signs | Resting Tremor | Rigidity | Bradykinesia | Postural reflex impairment
Item
idiopathic parkinson's disease as indicated by the presence of at least two of the following signs: resting tremor, rigidity, bradykinesia, or postural reflex impairment
boolean
C0030567 (UMLS CUI [1,1])
C0311392 (UMLS CUI [1,2])
C0234379 (UMLS CUI [2])
C0026837 (UMLS CUI [3])
C0233565 (UMLS CUI [4])
C1868839 (UMLS CUI [5])
Antiparkinson Agents Stable | Pharmaceutical Preparations unchanged
Item
stable anti-parkinson medication regimen, with no change in medications in the 4 weeks prior to study entry
boolean
C0003405 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C0442739 (UMLS CUI [2,2])
Antidepressive Agents | Antipsychotic Agents
Item
no antidepressant or antipsychotic medications within 30 days prior to study entry
boolean
C0003289 (UMLS CUI [1])
C0040615 (UMLS CUI [2])
Pharmacotherapy | Psychotherapy | Behavior Therapy | Study Subject Participation Status
Item
agree not to start other pharmacotherapy, psychotherapy, or behavior therapy while participating in the trial
boolean
C0013216 (UMLS CUI [1])
C0033968 (UMLS CUI [2])
C0004933 (UMLS CUI [3])
C2348568 (UMLS CUI [4])
Contraceptive methods Acceptable
Item
acceptable methods of contraception
boolean
C0700589 (UMLS CUI [1,1])
C1879533 (UMLS CUI [1,2])
Able to read Instructions written English Language | Instructions Oral English Language Compliance Ability
Item
ability to read and/or follow written and oral instructions presented in english
boolean
C0586740 (UMLS CUI [1,1])
C1442085 (UMLS CUI [1,2])
C1576874 (UMLS CUI [1,3])
C0376245 (UMLS CUI [1,4])
C1442085 (UMLS CUI [2,1])
C0442027 (UMLS CUI [2,2])
C0376245 (UMLS CUI [2,3])
C3714738 (UMLS CUI [2,4])
C0085732 (UMLS CUI [2,5])
Cognitive status Sufficient Informed Consent Related | Mini-mental state examination
Item
sufficient cognitive ability (baseline mini-mental status > 24) to provide informed consent
boolean
C0945985 (UMLS CUI [1,1])
C0205410 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
C0439849 (UMLS CUI [1,4])
C0451306 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Heart Diseases | Liver diseases | Kidney Diseases | Hematological Disease | Respiration Disorders | Endocrine System Diseases | Vascular Diseases | Metabolic Diseases | System Abnormality Relevant Clinical
Item
history of cardiac, hepatic, renal, hematologic, respiratory, endocrine, vascular, metabolic, or other systems abnormalities that are clinically relevant in the opinion of study officials
boolean
C0018799 (UMLS CUI [1])
C0023895 (UMLS CUI [2])
C0022658 (UMLS CUI [3])
C0018939 (UMLS CUI [4])
C0035204 (UMLS CUI [5])
C0014130 (UMLS CUI [6])
C0042373 (UMLS CUI [7])
C0025517 (UMLS CUI [8])
C0449913 (UMLS CUI [9,1])
C1704258 (UMLS CUI [9,2])
C2347946 (UMLS CUI [9,3])
C0205210 (UMLS CUI [9,4])
Laboratory test result abnormal
Item
certain abnormal laboratory values
boolean
C0438215 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnant or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Investigational New Drugs
Item
use of an investigational drug within 3 months of study entry
boolean
C0013230 (UMLS CUI [1])
ST. JOHN'S WORT EXTRACT | Natural Products Mood Enhancement
Item
use of st. john's wort or any other "natural" product known to have mood enhancing properties in the 30 days prior to study entry
boolean
C0813171 (UMLS CUI [1])
C1566558 (UMLS CUI [2,1])
C0026516 (UMLS CUI [2,2])
C2349975 (UMLS CUI [2,3])
Selegiline | Monoamine Oxidase Inhibitors
Item
selegiline or other monoamine oxidase inhibitor within the 6 weeks prior to study entry
boolean
C0036579 (UMLS CUI [1])
C0026457 (UMLS CUI [2])
Anti-Anxiety Agents Use Regular | taking medication to help sleep Habitual | Narcotics Use Infrequent | Temazepam | Melatonin | zolpidem
Item
regular usage of anti-anxiety medications or habitual use of sleep medications, although occasional use of certain hypnotics (temazepam, melatonin, or zolpidem) is allowed
boolean
C0040616 (UMLS CUI [1,1])
C1524063 (UMLS CUI [1,2])
C0205272 (UMLS CUI [1,3])
C2054158 (UMLS CUI [2,1])
C0205353 (UMLS CUI [2,2])
C0027415 (UMLS CUI [3,1])
C1524063 (UMLS CUI [3,2])
C0521114 (UMLS CUI [3,3])
C0039468 (UMLS CUI [4])
C0025219 (UMLS CUI [5])
C0078839 (UMLS CUI [6])
Psychotherapy Initiation
Item
psychotherapy initiated in the 6 months prior to study entry
boolean
C0033968 (UMLS CUI [1,1])
C1704686 (UMLS CUI [1,2])
Bipolar Disorder | Hypomania | Mania | Schizophrenia | Psychotic Disorders
Item
history of bipolar disorder, hypomania, mania, schizophrenia, or other psychotic disorder
boolean
C0005586 (UMLS CUI [1])
C0241934 (UMLS CUI [2])
C0338831 (UMLS CUI [3])
C0036341 (UMLS CUI [4])
C0033975 (UMLS CUI [5])
Suicide attempt Serious | Suicidal tendency Serious | Potential Suicidal Serious
Item
serious suicidal attempt in the 12 months prior to study entry or serious suicidal tendencies/potential
boolean
C0038663 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0235196 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C3245505 (UMLS CUI [3,1])
C0438696 (UMLS CUI [3,2])
C0205404 (UMLS CUI [3,3])
Dopamine Antagonists | Metoclopramide | Haloperidol
Item
use of dopamine receptor antagonist (metoclopramide, haloperidol)
boolean
C0242702 (UMLS CUI [1])
C0025853 (UMLS CUI [2])
C0018546 (UMLS CUI [3])
Parkinsonian Disorders Secondary Due to Pharmaceutical Preparations | Dopamine Antagonists | Metabolic Diseases | Cerebrovascular Disorders | Encephalitis | Degenerative disorder
Item
secondary parkinsonian symptoms due to drugs (including dopamine receptor antagonists), metabolic disorders, cerebrovascular disease, encephalitis, or other degenerative diseases
boolean
C0242422 (UMLS CUI [1,1])
C0175668 (UMLS CUI [1,2])
C0678226 (UMLS CUI [1,3])
C0013227 (UMLS CUI [1,4])
C0242702 (UMLS CUI [2])
C0025517 (UMLS CUI [3])
C0007820 (UMLS CUI [4])
C0014038 (UMLS CUI [5])
C1285162 (UMLS CUI [6])
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