ID

30475

Description

Study on the Tolerability of Duloxetine in Depressed Patients With Parkinson's Disease; ODM derived from: https://clinicaltrials.gov/show/NCT00437125

Link

https://clinicaltrials.gov/show/NCT00437125

Keywords

Versions (1)
  1. 6/6/18 6/6/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 6, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Major Depressive Disorder NCT00437125

English

Eligibility Major Depressive Disorder NCT00437125

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
are outpatients, male or female, 30 through 75 years of age
Description

Outpatients | Age

Data type

boolean

Alias
UMLS CUI [1]
C0029921
UMLS CUI [2]
C0001779
meet diagnostic criteria for major depression episode and a clinical diagnosis of idiopathic parkinson's disease
Description

Major depressive episode | Parkinson Disease

Data type

boolean

Alias
UMLS CUI [1]
C0024517
UMLS CUI [2]
C0030567
have a clinician-rated 17-item hamilton depression rating scale (hamd17) total score greater than or equal to 15, a beck depression inventory (bdi) total score greater than or equal to 13 and a clinical global impression of severity (cgi-s) score greater than or equal to 3 at both visit 1 and visit 2
Description

Hamilton Depression Rating Scale 17 Item Clinical Classification | Beck depression inventory | CGI - Severity of Illness

Data type

boolean

Alias
UMLS CUI [1]
C3639712
UMLS CUI [2]
C0451022
UMLS CUI [3]
C3639887
have satisfactory cognitive function
Description

Cognitive function satisfactory

Data type

boolean

Alias
UMLS CUI [1,1]
C0392335
UMLS CUI [1,2]
C0205410
have been held on stable dosage of antiparkinsonian medications for at least 4 weeks immediately prior to visit 1
Description

Antiparkinson Agents Dosage Stable

Data type

boolean

Alias
UMLS CUI [1,1]
C0003405
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
any current primary psychiatric diagnosis other than major depressive episode, and any personality disorder that could interfere with the compliance with the study protocol
Description

Psychiatric Diagnosis Except Major depressive episode | Personality Disorder Interferes with Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C0376338
UMLS CUI [1,2]
C0332300
UMLS CUI [1,3]
C0024517
UMLS CUI [2,1]
C0031212
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0525058
atypical or secondary parkinsonism due to drugs or diseases with features of parkinson's disease
Description

Atypical Parkinsonism | Secondary Parkinson Disease | Etiology Pharmaceutical Preparations Feature Parkinson Disease | Etiology Disease Feature Parkinson Disease

Data type

boolean

Alias
UMLS CUI [1]
C4302185
UMLS CUI [2]
C0030569
UMLS CUI [3,1]
C0015127
UMLS CUI [3,2]
C0013227
UMLS CUI [3,3]
C2348519
UMLS CUI [3,4]
C0030567
UMLS CUI [4,1]
C0015127
UMLS CUI [4,2]
C0012634
UMLS CUI [4,3]
C2348519
UMLS CUI [4,4]
C0030567
motor conditions for which it is to be expected to change the antiparkinsonian treatment during the course of the study
Description

Motor nerve Condition Changing Antiparkinson Agents

Data type

boolean

Alias
UMLS CUI [1,1]
C0501384
UMLS CUI [1,2]
C0348080
UMLS CUI [1,3]
C0392747
UMLS CUI [1,4]
C0003405
clinically significant laboratory abnormalities or serious, unstable medical illness
Description

Laboratory test result abnormal | Illness Serious Unstable

Data type

boolean

Alias
UMLS CUI [1]
C0438215
UMLS CUI [2,1]
C0221423
UMLS CUI [2,2]
C0205404
UMLS CUI [2,3]
C0443343
lack of response of current episode to two or more adequate courses of antidepressant therapy
Description

Depressive episode Unresponsive to Treatment | Antidepressive Agents | Course Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0349217
UMLS CUI [1,2]
C0205269
UMLS CUI [2]
C0003289
UMLS CUI [3,1]
C0750729
UMLS CUI [3,2]
C1265611
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Similar models

Eligibility Major Depressive Disorder NCT00437125

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Outpatients | Age
Item
are outpatients, male or female, 30 through 75 years of age
boolean
C0029921 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Major depressive episode | Parkinson Disease
Item
meet diagnostic criteria for major depression episode and a clinical diagnosis of idiopathic parkinson's disease
boolean
C0024517 (UMLS CUI [1])
C0030567 (UMLS CUI [2])
Hamilton Depression Rating Scale 17 Item Clinical Classification | Beck depression inventory | CGI - Severity of Illness
Item
have a clinician-rated 17-item hamilton depression rating scale (hamd17) total score greater than or equal to 15, a beck depression inventory (bdi) total score greater than or equal to 13 and a clinical global impression of severity (cgi-s) score greater than or equal to 3 at both visit 1 and visit 2
boolean
C3639712 (UMLS CUI [1])
C0451022 (UMLS CUI [2])
C3639887 (UMLS CUI [3])
Cognitive function satisfactory
Item
have satisfactory cognitive function
boolean
C0392335 (UMLS CUI [1,1])
C0205410 (UMLS CUI [1,2])
Antiparkinson Agents Dosage Stable
Item
have been held on stable dosage of antiparkinsonian medications for at least 4 weeks immediately prior to visit 1
boolean
C0003405 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Psychiatric Diagnosis Except Major depressive episode | Personality Disorder Interferes with Protocol Compliance
Item
any current primary psychiatric diagnosis other than major depressive episode, and any personality disorder that could interfere with the compliance with the study protocol
boolean
C0376338 (UMLS CUI [1,1])
C0332300 (UMLS CUI [1,2])
C0024517 (UMLS CUI [1,3])
C0031212 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
Atypical Parkinsonism | Secondary Parkinson Disease | Etiology Pharmaceutical Preparations Feature Parkinson Disease | Etiology Disease Feature Parkinson Disease
Item
atypical or secondary parkinsonism due to drugs or diseases with features of parkinson's disease
boolean
C4302185 (UMLS CUI [1])
C0030569 (UMLS CUI [2])
C0015127 (UMLS CUI [3,1])
C0013227 (UMLS CUI [3,2])
C2348519 (UMLS CUI [3,3])
C0030567 (UMLS CUI [3,4])
C0015127 (UMLS CUI [4,1])
C0012634 (UMLS CUI [4,2])
C2348519 (UMLS CUI [4,3])
C0030567 (UMLS CUI [4,4])
Motor nerve Condition Changing Antiparkinson Agents
Item
motor conditions for which it is to be expected to change the antiparkinsonian treatment during the course of the study
boolean
C0501384 (UMLS CUI [1,1])
C0348080 (UMLS CUI [1,2])
C0392747 (UMLS CUI [1,3])
C0003405 (UMLS CUI [1,4])
Laboratory test result abnormal | Illness Serious Unstable
Item
clinically significant laboratory abnormalities or serious, unstable medical illness
boolean
C0438215 (UMLS CUI [1])
C0221423 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0443343 (UMLS CUI [2,3])
Depressive episode Unresponsive to Treatment | Antidepressive Agents | Course Quantity
Item
lack of response of current episode to two or more adequate courses of antidepressant therapy
boolean
C0349217 (UMLS CUI [1,1])
C0205269 (UMLS CUI [1,2])
C0003289 (UMLS CUI [2])
C0750729 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
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