ID

17037

Description

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

Link

https://clinicaltrials.gov/show/NCT00231959

Keywords

Versions (1)
  1. 8/22/16 8/22/16 -
Uploaded on

August 22, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Depression NCT00231959

English

Eligibility Depression NCT00231959

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT00231959
Inclusion Criteria
Description

Inclusion Criteria

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

Major Depressive Disorder

Data type

boolean

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

Single major depressive episode

Data type

boolean

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

Montgomery-Asberg Depression Rating Scale Questionnaire

Data type

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
Description

Antidepressive Agents Dosage

Data type

boolean

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

Contraceptive methods Agree

Data type

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant
Description

Pregnancy

Data type

boolean

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

At risk for suicide | Homicide At risk

Data type

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)
Description

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

Data type

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
Description

Substance Use Disorders

Data type

boolean

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

depression psychotic feature

Data type

boolean

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

Antipsychotic Agents | Antipsychotic Agents Atypical

Data type

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)
Description

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

Data type

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
Description

Hypothyroidism untreated Evidence of

Data type

boolean

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

Pramipexole Course Length

Data type

boolean

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

intolerance to Pramipexole Dosage

Data type

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
Description

Psychotropic Drugs Investigational

Data type

boolean

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

Antidepressive Agents Resistance Level

Data type

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
Description

Self-harm Episodes Quantity

Data type

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
Description

Adherence to treatment Poor | Missed appointment Frequently

Data type

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
Description

Parkinson Disease

Data type

boolean

Alias
UMLS CUI [1]
C0030567
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Similar models

Eligibility Depression NCT00231959

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT00231959
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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