ID

17037

Beskrivning

Effectiveness of Pramipexole for Treatment-Resistant Depression; ODM derived from: https://clinicaltrials.gov/show/NCT00231959

Länk

https://clinicaltrials.gov/show/NCT00231959

Nyckelord

Versioner (1)
  1. 2016-08-22 2016-08-22 -
Uppladdad den

22 augusti 2016

DOI

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Creative Commons BY 4.0
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Eligibility Depression NCT00231959

Engelsk

Eligibility Depression NCT00231959

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT00231959
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
meets diagnostic criteria for major depressive disorder
Beskrivning

Major Depressive Disorder

Datatyp

boolean

Alias
UMLS CUI [1]
C1269683
meets criteria for current major depressive episode
Beskrivning

Single major depressive episode

Datatyp

boolean

Alias
UMLS CUI [1]
C0024517
score of at least 18 on the montgomery-asberg depression rating scale (madrs) at the baseline visit
Beskrivning

Montgomery-Asberg Depression Rating Scale Questionnaire

Datatyp

boolean

Alias
UMLS CUI [1]
C4054475
currently being treated with antidepressant monotherapy at an adequate dose for 6 weeks or willing to enter open lead-in treatment
Beskrivning

Antidepressive Agents Dosage

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0003289
UMLS CUI [1,2]
C0178602
agrees to use an effective form of contraception throughout the study
Beskrivning

Contraceptive methods Agree

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C3641827
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant
Beskrivning

Pregnancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
at risk for suicide or homicide
Beskrivning

At risk for suicide | Homicide At risk

Datatyp

boolean

Alias
UMLS CUI [1]
C0563664
UMLS CUI [2,1]
C0019872
UMLS CUI [2,2]
C1444641
unstable medical illness (e.g., cardiovascular, liver, kidney, respiratory, endocrine, or neurologic disease, including uncontrolled seizure disorder)
Beskrivning

Illness Unstable | Cardiovascular Diseases | Liver diseases | Kidney Diseases | Respiration Disorders | Endocrine System Diseases | nervous system disorder | Epilepsy Uncontrolled

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0443343
UMLS CUI [2]
C0007222
UMLS CUI [3]
C0023895
UMLS CUI [4]
C0022658
UMLS CUI [5]
C0035204
UMLS CUI [6]
C0014130
UMLS CUI [7]
C0027765
UMLS CUI [8,1]
C0014544
UMLS CUI [8,2]
C0205318
history of a substance use disorder within 6 months of study enrollment
Beskrivning

Substance Use Disorders

Datatyp

boolean

Alias
UMLS CUI [1]
C0038586
history of or current psychotic features
Beskrivning

depression psychotic feature

Datatyp

boolean

Alias
UMLS CUI [1]
C0743076
currently being treated with typical or atypical antipsychotic medications
Beskrivning

Antipsychotic Agents | Antipsychotic Agents Atypical

Datatyp

boolean

Alias
UMLS CUI [1]
C0040615
UMLS CUI [2,1]
C0040615
UMLS CUI [2,2]
C0205182
currently being treated with a medication known to significantly decrease pramipexole clearance (e.g., cimetidine, ranitidine, diltazem, verapamil, quinine or triamterene)
Beskrivning

Pharmaceutical Preparations Decreasing Significant Pramipexole Clearance | Cimetidine | Ranitidine | Dilacor | Verapamil | Quinine | Triamterene

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0442797
UMLS CUI [1,3]
C0750502
UMLS CUI [1,4]
C0074710
UMLS CUI [1,5]
C1382187
UMLS CUI [2]
C0008783
UMLS CUI [3]
C0034665
UMLS CUI [4]
C2587066
UMLS CUI [5]
C0042523
UMLS CUI [6]
C0034417
UMLS CUI [7]
C0040869
clinical or laboratory evidence of untreated hypothyroidism
Beskrivning

Hypothyroidism untreated Evidence of

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2749407
UMLS CUI [1,2]
C0332120
history of a 2-week or longer course of pramipexole
Beskrivning

Pramipexole Course Length

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0074710
UMLS CUI [1,2]
C0750729
UMLS CUI [1,3]
C1444754
intolerance of pramipexole at any dose
Beskrivning

intolerance to Pramipexole Dosage

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C0074710
UMLS CUI [1,3]
C0178602
any investigational psychotropic drug use within the last three months
Beskrivning

Psychotropic Drugs Investigational

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0033978
UMLS CUI [1,2]
C1517586
level 3 or greater antidepressant resistance as assessed by the athf
Beskrivning

Antidepressive Agents Resistance Level

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0003289
UMLS CUI [1,2]
C0013203
UMLS CUI [1,3]
C0441889
three or more episodes of self-harm in the year prior to study enrollment
Beskrivning

Self-harm Episodes Quantity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0424366
UMLS CUI [1,2]
C0332189
UMLS CUI [1,3]
C1265611
documented history of poor treatment adherence or frequently missed appointments
Beskrivning

Adherence to treatment Poor | Missed appointment Frequently

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0516958
UMLS CUI [1,2]
C2700379
UMLS CUI [2,1]
C3854235
UMLS CUI [2,2]
C0332183
parkinson's disease
Beskrivning

Parkinson Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0030567
Tillbaka till toppen

Similar models

Eligibility Depression NCT00231959

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT00231959
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Major Depressive Disorder
Item
meets diagnostic criteria for major depressive disorder
boolean
C1269683 (UMLS CUI [1])
Single major depressive episode
Item
meets criteria for current major depressive episode
boolean
C0024517 (UMLS CUI [1])
Montgomery-Asberg Depression Rating Scale Questionnaire
Item
score of at least 18 on the montgomery-asberg depression rating scale (madrs) at the baseline visit
boolean
C4054475 (UMLS CUI [1])
Antidepressive Agents Dosage
Item
currently being treated with antidepressant monotherapy at an adequate dose for 6 weeks or willing to enter open lead-in treatment
boolean
C0003289 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Contraceptive methods Agree
Item
agrees to use an effective form of contraception throughout the study
boolean
C0700589 (UMLS CUI [1,1])
C3641827 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Pregnancy
Item
pregnant
boolean
C0032961 (UMLS CUI [1])
At risk for suicide | Homicide At risk
Item
at risk for suicide or homicide
boolean
C0563664 (UMLS CUI [1])
C0019872 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
Illness Unstable | Cardiovascular Diseases | Liver diseases | Kidney Diseases | Respiration Disorders | Endocrine System Diseases | nervous system disorder | Epilepsy Uncontrolled
Item
unstable medical illness (e.g., cardiovascular, liver, kidney, respiratory, endocrine, or neurologic disease, including uncontrolled seizure disorder)
boolean
C0221423 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0007222 (UMLS CUI [2])
C0023895 (UMLS CUI [3])
C0022658 (UMLS CUI [4])
C0035204 (UMLS CUI [5])
C0014130 (UMLS CUI [6])
C0027765 (UMLS CUI [7])
C0014544 (UMLS CUI [8,1])
C0205318 (UMLS CUI [8,2])
Substance Use Disorders
Item
history of a substance use disorder within 6 months of study enrollment
boolean
C0038586 (UMLS CUI [1])
depression psychotic feature
Item
history of or current psychotic features
boolean
C0743076 (UMLS CUI [1])
Antipsychotic Agents | Antipsychotic Agents Atypical
Item
currently being treated with typical or atypical antipsychotic medications
boolean
C0040615 (UMLS CUI [1])
C0040615 (UMLS CUI [2,1])
C0205182 (UMLS CUI [2,2])
Pharmaceutical Preparations Decreasing Significant Pramipexole Clearance | Cimetidine | Ranitidine | Dilacor | Verapamil | Quinine | Triamterene
Item
currently being treated with a medication known to significantly decrease pramipexole clearance (e.g., cimetidine, ranitidine, diltazem, verapamil, quinine or triamterene)
boolean
C0013227 (UMLS CUI [1,1])
C0442797 (UMLS CUI [1,2])
C0750502 (UMLS CUI [1,3])
C0074710 (UMLS CUI [1,4])
C1382187 (UMLS CUI [1,5])
C0008783 (UMLS CUI [2])
C0034665 (UMLS CUI [3])
C2587066 (UMLS CUI [4])
C0042523 (UMLS CUI [5])
C0034417 (UMLS CUI [6])
C0040869 (UMLS CUI [7])
Hypothyroidism untreated Evidence of
Item
clinical or laboratory evidence of untreated hypothyroidism
boolean
C2749407 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
Pramipexole Course Length
Item
history of a 2-week or longer course of pramipexole
boolean
C0074710 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
C1444754 (UMLS CUI [1,3])
intolerance to Pramipexole Dosage
Item
intolerance of pramipexole at any dose
boolean
C1744706 (UMLS CUI [1,1])
C0074710 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
Psychotropic Drugs Investigational
Item
any investigational psychotropic drug use within the last three months
boolean
C0033978 (UMLS CUI [1,1])
C1517586 (UMLS CUI [1,2])
Antidepressive Agents Resistance Level
Item
level 3 or greater antidepressant resistance as assessed by the athf
boolean
C0003289 (UMLS CUI [1,1])
C0013203 (UMLS CUI [1,2])
C0441889 (UMLS CUI [1,3])
Self-harm Episodes Quantity
Item
three or more episodes of self-harm in the year prior to study enrollment
boolean
C0424366 (UMLS CUI [1,1])
C0332189 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Adherence to treatment Poor | Missed appointment Frequently
Item
documented history of poor treatment adherence or frequently missed appointments
boolean
C0516958 (UMLS CUI [1,1])
C2700379 (UMLS CUI [1,2])
C3854235 (UMLS CUI [2,1])
C0332183 (UMLS CUI [2,2])
Parkinson Disease
Item
parkinson's disease
boolean
C0030567 (UMLS CUI [1])
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