ID

30473

Beschrijving

Efficacy and Safety of SR58611A co-Administered With Escitalopram in Adults With Major Depressive Disorder; ODM derived from: https://clinicaltrials.gov/show/NCT00432614

Link

https://clinicaltrials.gov/show/NCT00432614

Trefwoorden

Versies (2)
  1. 06-06-18 06-06-18 -
  2. 06-06-18 06-06-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

6 juni 2018

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Major Depressive Disorder NCT00432614

Engels

Eligibility Major Depressive Disorder NCT00432614

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
inpatients or outpatients with major depressive disorder characterized by a recurrent major depressive episode with montgomery and asberg depression rating scale (madrs) total score => 30
Beschrijving

Inpatients | Outpatients | Major Depressive Disorder Montgomery-Asberg Depression Rating Scale Questionnaire | Recurrent major depressive episodes

Datatype

boolean

Alias
UMLS CUI [1]
C0021562
UMLS CUI [2]
C0029921
UMLS CUI [3,1]
C1269683
UMLS CUI [3,2]
C4054475
UMLS CUI [4]
C0154409
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient is at immediate risk for suicidal behavior
Beschrijving

At risk Suicidal behavior

Datatype

boolean

Alias
UMLS CUI [1,1]
C1444641
UMLS CUI [1,2]
C1760428
patient with psychotic features, catatonic features, seasonal pattern or postpartum onset
Beschrijving

Psychotic symptom present | Feature Catatonic | Seasonal Affective Disorder | Depression, Postpartum

Datatype

boolean

Alias
UMLS CUI [1]
C0459435
UMLS CUI [2,1]
C2348519
UMLS CUI [2,2]
C0007398
UMLS CUI [3]
C0085159
UMLS CUI [4]
C0221074
patients with a current depressive episode secondary to a general medical disorder
Beschrijving

Depressive episode Secondary to Disease General

Datatype

boolean

Alias
UMLS CUI [1,1]
C0349217
UMLS CUI [1,2]
C0175668
UMLS CUI [1,3]
C0012634
UMLS CUI [1,4]
C0205246
patients with a lifetime history or presence of bipolar disorder, psychotic disorder, panic disorder and antisocial personality disorder
Beschrijving

Bipolar Disorder Lifetime | Psychotic Disorders Lifetime | Panic Disorder Lifetime | Antisocial Personality Disorder Lifetime | Bipolar Disorder | Psychotic Disorders | Panic Disorder | Antisocial Personality Disorder

Datatype

boolean

Alias
UMLS CUI [1,1]
C0005586
UMLS CUI [1,2]
C4071830
UMLS CUI [2,1]
C0033975
UMLS CUI [2,2]
C4071830
UMLS CUI [3,1]
C0030319
UMLS CUI [3,2]
C4071830
UMLS CUI [4,1]
C0003431
UMLS CUI [4,2]
C4071830
UMLS CUI [5]
C0005586
UMLS CUI [6]
C0033975
UMLS CUI [7]
C0030319
UMLS CUI [8]
C0003431
patients with severe or unstable concomitant medical conditions
Beschrijving

Comorbidity Severe | Comorbidity Unstable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0443343
pregnant, breastfeeding, or likely to become pregnant during the study
Beschrijving

Pregnancy | Breast Feeding | Pregnancy Probably

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0032961
UMLS CUI [3,2]
C0750492
treated with escitalopram within 6 months before the study, or who have had an adverse reaction to escitalopram
Beschrijving

Escitalopram | Adverse reaction Escitalopram

Datatype

boolean

Alias
UMLS CUI [1]
C1099456
UMLS CUI [2,1]
C0559546
UMLS CUI [2,2]
C1099456
the investigator will evaluate whether there are other reasons why a patient may not participate.
Beschrijving

Other Reason Study Subject Participation Status Excluded

Datatype

boolean

Alias
UMLS CUI [1,1]
C3840932
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C0332196
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Similar models

Eligibility Major Depressive Disorder NCT00432614

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Inpatients | Outpatients | Major Depressive Disorder Montgomery-Asberg Depression Rating Scale Questionnaire | Recurrent major depressive episodes
Item
inpatients or outpatients with major depressive disorder characterized by a recurrent major depressive episode with montgomery and asberg depression rating scale (madrs) total score => 30
boolean
C0021562 (UMLS CUI [1])
C0029921 (UMLS CUI [2])
C1269683 (UMLS CUI [3,1])
C4054475 (UMLS CUI [3,2])
C0154409 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
At risk Suicidal behavior
Item
patient is at immediate risk for suicidal behavior
boolean
C1444641 (UMLS CUI [1,1])
C1760428 (UMLS CUI [1,2])
Psychotic symptom present | Feature Catatonic | Seasonal Affective Disorder | Depression, Postpartum
Item
patient with psychotic features, catatonic features, seasonal pattern or postpartum onset
boolean
C0459435 (UMLS CUI [1])
C2348519 (UMLS CUI [2,1])
C0007398 (UMLS CUI [2,2])
C0085159 (UMLS CUI [3])
C0221074 (UMLS CUI [4])
Depressive episode Secondary to Disease General
Item
patients with a current depressive episode secondary to a general medical disorder
boolean
C0349217 (UMLS CUI [1,1])
C0175668 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,3])
C0205246 (UMLS CUI [1,4])
Bipolar Disorder Lifetime | Psychotic Disorders Lifetime | Panic Disorder Lifetime | Antisocial Personality Disorder Lifetime | Bipolar Disorder | Psychotic Disorders | Panic Disorder | Antisocial Personality Disorder
Item
patients with a lifetime history or presence of bipolar disorder, psychotic disorder, panic disorder and antisocial personality disorder
boolean
C0005586 (UMLS CUI [1,1])
C4071830 (UMLS CUI [1,2])
C0033975 (UMLS CUI [2,1])
C4071830 (UMLS CUI [2,2])
C0030319 (UMLS CUI [3,1])
C4071830 (UMLS CUI [3,2])
C0003431 (UMLS CUI [4,1])
C4071830 (UMLS CUI [4,2])
C0005586 (UMLS CUI [5])
C0033975 (UMLS CUI [6])
C0030319 (UMLS CUI [7])
C0003431 (UMLS CUI [8])
Comorbidity Severe | Comorbidity Unstable
Item
patients with severe or unstable concomitant medical conditions
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0009488 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
Pregnancy | Breast Feeding | Pregnancy Probably
Item
pregnant, breastfeeding, or likely to become pregnant during the study
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032961 (UMLS CUI [3,1])
C0750492 (UMLS CUI [3,2])
Escitalopram | Adverse reaction Escitalopram
Item
treated with escitalopram within 6 months before the study, or who have had an adverse reaction to escitalopram
boolean
C1099456 (UMLS CUI [1])
C0559546 (UMLS CUI [2,1])
C1099456 (UMLS CUI [2,2])
Other Reason Study Subject Participation Status Excluded
Item
the investigator will evaluate whether there are other reasons why a patient may not participate.
boolean
C3840932 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0332196 (UMLS CUI [1,3])
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