ID

40365

Description

Rotigotine Versus Placebo to Evaluate the Efficacy on Depressive Symptoms in Idiopathic Parkinson's Disease Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01523301

Link

https://clinicaltrials.gov/show/NCT01523301

Keywords

Versions (1)
  1. 4/14/20 4/14/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 14, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Idiopathic Parkinson's Disease NCT01523301

English

Eligibility Idiopathic Parkinson's Disease NCT01523301

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female subjects ≥ 20 years old
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
subjects diagnosed with idiopathic parkinson's disease (according to the united kingdom parkinson's disease society brain bank diagnostic criteria for parkinson's disease) at modified hoehn and yahr scale stages i-iii; do not have motor fluctuations, dyskinesia, and have stable motor symptom at least 4 weeks prior to the screening visit as judged by the local investigator
Description

Parkinson Disease | UPDRS - Modified Hoehn and Yahr Staging | Motor fluctuations Absent | Dyskinetic syndrome | Motor symptoms Stable

Data type

boolean

Alias
UMLS CUI [1]
C0030567
UMLS CUI [2]
C3639878
UMLS CUI [3,1]
C1868976
UMLS CUI [3,2]
C0332197
UMLS CUI [4]
C0013384
UMLS CUI [5,1]
C0426980
UMLS CUI [5,2]
C0205360
subject has a hamilton depression scale (ham- d) score ≥ 16 as evidenced by depression rating scale study in parkinson's disease (schrag a et al, 2007)
Description

Hamilton rating scale for depression

Data type

boolean

Alias
UMLS CUI [1]
C0451203
subject has a mini-mental state examination (mmse) score ≥ 24
Description

Mini-mental state examination

Data type

boolean

Alias
UMLS CUI [1]
C0451306
if subject is taking levodopa (l-dopa) and derivatives, monoamine oxidase (mao) b-inhibitors, anticholinergics agents, catechol-o-methyl transferase (comt) inhibitor or n-methyl-d-aspartate (nmda) antagonist, he/she must have been on stable dose for at least 28 days prior to the screening visit
Description

Levodopa | Levodopa Derivative | Monoamine Oxidase Inhibitors | Anticholinergic Agents | Catechol-O-methyltransferase inhibitor | NMDA Receptor Antagonists

Data type

boolean

Alias
UMLS CUI [1]
C0023570
UMLS CUI [2,1]
C0023570
UMLS CUI [2,2]
C1527240
UMLS CUI [3]
C0026457
UMLS CUI [4]
C0242896
UMLS CUI [5]
C0595267
UMLS CUI [6]
C2916808
if subject is taking an antidepressant drug such as selective serotonin reuptake inhibitors (ssris), serotonin-norepinephrine reuptake inhibitors (snris), bupropion, tricyclic antidepressants (tcas), he/she must have been on a stable dose for at least 28 days prior to the screening visit and be maintained on that dose for the duration of the trial
Description

Antidepressive Agents | Selective Serotonin Reuptake Inhibitors | Serotonin and Norepinephrine Reuptake Inhibitors (SNRIs) | Bupropion | Tricyclic Antidepressive Agents

Data type

boolean

Alias
UMLS CUI [1]
C0003289
UMLS CUI [2]
C0360105
UMLS CUI [3]
C1579361
UMLS CUI [4]
C0085208
UMLS CUI [5]
C0003290
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
subject has any medical or psychiatric condition (ie, bipolar disorder, dementia, hallucinations or psychosis) that, in the opinion of the investigator, could jeopardize or would compromise the subject's ability to participate in this study
Description

Medical condition At risk Study Subject Participation Status | Mental condition At risk Study Subject Participation Status | Medical condition Impairing Study Subject Participation Status | Mental condition Impairing Study Subject Participation Status | Bipolar Disorder | Dementia | Hallucinations | Psychotic Disorders

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C1444641
UMLS CUI [1,3]
C2348568
UMLS CUI [2,1]
C3840291
UMLS CUI [2,2]
C1444641
UMLS CUI [2,3]
C2348568
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C0221099
UMLS CUI [3,3]
C2348568
UMLS CUI [4,1]
C3840291
UMLS CUI [4,2]
C0221099
UMLS CUI [4,3]
C2348568
UMLS CUI [5]
C0005586
UMLS CUI [6]
C0497327
UMLS CUI [7]
C0018524
UMLS CUI [8]
C0033975
subject has a lifetime history of suicide attempt (including an active attempt, interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6 months as indicated by a positive response ('yes') to either question 4 or question 5 of the c-ssrs at screening (visit 1)
Description

History of attempted suicide Lifetime | Suicide attempt | Suicide attempt Interrupted | Feeling suicidal Columbia-Suicide Severity Rating Scale Screening Questionnaire

Data type

boolean

Alias
UMLS CUI [1,1]
C0455507
UMLS CUI [1,2]
C4071830
UMLS CUI [2]
C0038663
UMLS CUI [3,1]
C0038663
UMLS CUI [3,2]
C1512900
UMLS CUI [4,1]
C0424000
UMLS CUI [4,2]
C3827015
current psychotherapy or behavior therapy while participating in this study
Description

Psychotherapy | Behavior Therapy

Data type

boolean

Alias
UMLS CUI [1]
C0033968
UMLS CUI [2]
C0004933
subject has received electroconvulsive therapy within 12 weeks of the screening visit
Description

Electroconvulsive Therapy

Data type

boolean

Alias
UMLS CUI [1]
C0013806
subject who has received dopamine agonists within 28 days of the screening visit
Description

Dopamine Agonists

Data type

boolean

Alias
UMLS CUI [1]
C0178601
subject who has received neuroleptics, methylphenidate, reserpine, alpha-methyldopa, metoclopramide, levosulpiride or amphetamine derivatives within 28 days of the screening visit
Description

Antipsychotic Agents | Methylphenidate | Reserpine | Methyldopa | Metoclopramide | levosulpiride | Amphetamine Derivative

Data type

boolean

Alias
UMLS CUI [1]
C0040615
UMLS CUI [2]
C0025810
UMLS CUI [3]
C0035179
UMLS CUI [4]
C0025741
UMLS CUI [5]
C0025853
UMLS CUI [6]
C0210380
UMLS CUI [7,1]
C0002658
UMLS CUI [7,2]
C1527240
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Similar models

Eligibility Idiopathic Parkinson's Disease NCT01523301

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
male or female subjects ≥ 20 years old
boolean
C0001779 (UMLS CUI [1])
Parkinson Disease | UPDRS - Modified Hoehn and Yahr Staging | Motor fluctuations Absent | Dyskinetic syndrome | Motor symptoms Stable
Item
subjects diagnosed with idiopathic parkinson's disease (according to the united kingdom parkinson's disease society brain bank diagnostic criteria for parkinson's disease) at modified hoehn and yahr scale stages i-iii; do not have motor fluctuations, dyskinesia, and have stable motor symptom at least 4 weeks prior to the screening visit as judged by the local investigator
boolean
C0030567 (UMLS CUI [1])
C3639878 (UMLS CUI [2])
C1868976 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0013384 (UMLS CUI [4])
C0426980 (UMLS CUI [5,1])
C0205360 (UMLS CUI [5,2])
Hamilton rating scale for depression
Item
subject has a hamilton depression scale (ham- d) score ≥ 16 as evidenced by depression rating scale study in parkinson's disease (schrag a et al, 2007)
boolean
C0451203 (UMLS CUI [1])
Mini-mental state examination
Item
subject has a mini-mental state examination (mmse) score ≥ 24
boolean
C0451306 (UMLS CUI [1])
Levodopa | Levodopa Derivative | Monoamine Oxidase Inhibitors | Anticholinergic Agents | Catechol-O-methyltransferase inhibitor | NMDA Receptor Antagonists
Item
if subject is taking levodopa (l-dopa) and derivatives, monoamine oxidase (mao) b-inhibitors, anticholinergics agents, catechol-o-methyl transferase (comt) inhibitor or n-methyl-d-aspartate (nmda) antagonist, he/she must have been on stable dose for at least 28 days prior to the screening visit
boolean
C0023570 (UMLS CUI [1])
C0023570 (UMLS CUI [2,1])
C1527240 (UMLS CUI [2,2])
C0026457 (UMLS CUI [3])
C0242896 (UMLS CUI [4])
C0595267 (UMLS CUI [5])
C2916808 (UMLS CUI [6])
Antidepressive Agents | Selective Serotonin Reuptake Inhibitors | Serotonin and Norepinephrine Reuptake Inhibitors (SNRIs) | Bupropion | Tricyclic Antidepressive Agents
Item
if subject is taking an antidepressant drug such as selective serotonin reuptake inhibitors (ssris), serotonin-norepinephrine reuptake inhibitors (snris), bupropion, tricyclic antidepressants (tcas), he/she must have been on a stable dose for at least 28 days prior to the screening visit and be maintained on that dose for the duration of the trial
boolean
C0003289 (UMLS CUI [1])
C0360105 (UMLS CUI [2])
C1579361 (UMLS CUI [3])
C0085208 (UMLS CUI [4])
C0003290 (UMLS CUI [5])
Item Group
C0680251 (UMLS CUI)
Medical condition At risk Study Subject Participation Status | Mental condition At risk Study Subject Participation Status | Medical condition Impairing Study Subject Participation Status | Mental condition Impairing Study Subject Participation Status | Bipolar Disorder | Dementia | Hallucinations | Psychotic Disorders
Item
subject has any medical or psychiatric condition (ie, bipolar disorder, dementia, hallucinations or psychosis) that, in the opinion of the investigator, could jeopardize or would compromise the subject's ability to participate in this study
boolean
C3843040 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C3840291 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
C3843040 (UMLS CUI [3,1])
C0221099 (UMLS CUI [3,2])
C2348568 (UMLS CUI [3,3])
C3840291 (UMLS CUI [4,1])
C0221099 (UMLS CUI [4,2])
C2348568 (UMLS CUI [4,3])
C0005586 (UMLS CUI [5])
C0497327 (UMLS CUI [6])
C0018524 (UMLS CUI [7])
C0033975 (UMLS CUI [8])
History of attempted suicide Lifetime | Suicide attempt | Suicide attempt Interrupted | Feeling suicidal Columbia-Suicide Severity Rating Scale Screening Questionnaire
Item
subject has a lifetime history of suicide attempt (including an active attempt, interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6 months as indicated by a positive response ('yes') to either question 4 or question 5 of the c-ssrs at screening (visit 1)
boolean
C0455507 (UMLS CUI [1,1])
C4071830 (UMLS CUI [1,2])
C0038663 (UMLS CUI [2])
C0038663 (UMLS CUI [3,1])
C1512900 (UMLS CUI [3,2])
C0424000 (UMLS CUI [4,1])
C3827015 (UMLS CUI [4,2])
Psychotherapy | Behavior Therapy
Item
current psychotherapy or behavior therapy while participating in this study
boolean
C0033968 (UMLS CUI [1])
C0004933 (UMLS CUI [2])
Electroconvulsive Therapy
Item
subject has received electroconvulsive therapy within 12 weeks of the screening visit
boolean
C0013806 (UMLS CUI [1])
Dopamine Agonists
Item
subject who has received dopamine agonists within 28 days of the screening visit
boolean
C0178601 (UMLS CUI [1])
Antipsychotic Agents | Methylphenidate | Reserpine | Methyldopa | Metoclopramide | levosulpiride | Amphetamine Derivative
Item
subject who has received neuroleptics, methylphenidate, reserpine, alpha-methyldopa, metoclopramide, levosulpiride or amphetamine derivatives within 28 days of the screening visit
boolean
C0040615 (UMLS CUI [1])
C0025810 (UMLS CUI [2])
C0035179 (UMLS CUI [3])
C0025741 (UMLS CUI [4])
C0025853 (UMLS CUI [5])
C0210380 (UMLS CUI [6])
C0002658 (UMLS CUI [7,1])
C1527240 (UMLS CUI [7,2])
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