ID

20548

Description

A Study of SR58611A in the Prevention of Depression Relapse in Patients With Major Depressive Disorder; ODM derived from: https://clinicaltrials.gov/show/NCT00345098

Lien

https://clinicaltrials.gov/show/NCT00345098

Mots-clés

Versions (1)
  1. 02/03/2017 02/03/2017 -
Téléchargé le

2 mars 2017

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
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Eligibility Depressive Disorder NCT00345098

Anglais

Eligibility Depressive Disorder NCT00345098

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients diagnosed with major depressive disorder, recurrent according to dsm-iv-tr criteria diagnostic and statistical manual of mental disorders (fourth edition) and assessed with the mini international neuropsychiatric interview (mini)
Description

Major Depressive Disorder Recurrent

Type de données

boolean

Alias
UMLS CUI [1,1]
C1269683
UMLS CUI [1,2]
C2945760
total score on the montgomery and asberg depression rating scale (madrs) > 28
Description

Montgomery-Asberg Depression Rating Scale Questionnaire

Type de données

boolean

Alias
UMLS CUI [1]
C4054475
at w12 (v7), patients will be randomized into the double-blind treatment phase if they have madrs total score < 12
Description

Montgomery-Asberg Depression Rating Scale Questionnaire | Randomization | Double-Blind Method

Type de données

boolean

Alias
UMLS CUI [1]
C4054475
UMLS CUI [2]
C0034656
UMLS CUI [3]
C0013072
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with a significant risk of suicide.
Description

At risk for suicide

Type de données

boolean

Alias
UMLS CUI [1]
C0563664
patients whose current depressive episode is diagnosed with psychotic features, catatonic features, seasonal pattern or post-partum onset.
Description

Depressive episode | depression psychotic feature | Catatonic phenomena | Seasonal depression | Depression, Postpartum

Type de données

boolean

Alias
UMLS CUI [1]
C0349217
UMLS CUI [2]
C0743076
UMLS CUI [3]
C0856959
UMLS CUI [4]
C0085159
UMLS CUI [5]
C0221074
patients with a current depressive episode secondary to a general medical disorder.
Description

Depressive episode Secondary to Medical condition General

Type de données

boolean

Alias
UMLS CUI [1,1]
C0349217
UMLS CUI [1,2]
C0175668
UMLS CUI [1,3]
C3843040
UMLS CUI [1,4]
C0205246
patients with a lifetime history or presence of bipolar disorder, psychotic disorder, panic disorder and antisocial personality disorder.
Description

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

Type de données

boolean

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

Comorbidity Severe | Comorbidity Unstable

Type de données

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0443343
patients with clinically significant abnormal laboratory value at screening
Description

Laboratory test result abnormal

Type de données

boolean

Alias
UMLS CUI [1]
C0438215
the investigator will evaluate whether there are other reasons why a patient may not participate
Description

Study Subject Participation Status | Evaluation Investigator

Type de données

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C1261322
UMLS CUI [2,2]
C0035173
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Similar models

Eligibility Depressive Disorder NCT00345098

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Major Depressive Disorder Recurrent
Item
patients diagnosed with major depressive disorder, recurrent according to dsm-iv-tr criteria diagnostic and statistical manual of mental disorders (fourth edition) and assessed with the mini international neuropsychiatric interview (mini)
boolean
C1269683 (UMLS CUI [1,1])
C2945760 (UMLS CUI [1,2])
Montgomery-Asberg Depression Rating Scale Questionnaire
Item
total score on the montgomery and asberg depression rating scale (madrs) > 28
boolean
C4054475 (UMLS CUI [1])
Montgomery-Asberg Depression Rating Scale Questionnaire | Randomization | Double-Blind Method
Item
at w12 (v7), patients will be randomized into the double-blind treatment phase if they have madrs total score < 12
boolean
C4054475 (UMLS CUI [1])
C0034656 (UMLS CUI [2])
C0013072 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
At risk for suicide
Item
patients with a significant risk of suicide.
boolean
C0563664 (UMLS CUI [1])
Depressive episode | depression psychotic feature | Catatonic phenomena | Seasonal depression | Depression, Postpartum
Item
patients whose current depressive episode is diagnosed with psychotic features, catatonic features, seasonal pattern or post-partum onset.
boolean
C0349217 (UMLS CUI [1])
C0743076 (UMLS CUI [2])
C0856959 (UMLS CUI [3])
C0085159 (UMLS CUI [4])
C0221074 (UMLS CUI [5])
Depressive episode Secondary to Medical condition 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])
C3843040 (UMLS CUI [1,3])
C0205246 (UMLS CUI [1,4])
Bipolar Disorder | Psychotic Disorder | Panic Disorder | Antisocial Personality Disorder | Bipolar Disorder Lifetime | Psychotic Disorder Lifetime | Panic Disorder Lifetime | Antisocial Personality Disorder Lifetime
Item
patients with a lifetime history or presence of bipolar disorder, psychotic disorder, panic disorder and antisocial personality disorder.
boolean
C0005586 (UMLS CUI [1])
C0033975 (UMLS CUI [2])
C0030319 (UMLS CUI [3])
C0003431 (UMLS CUI [4])
C0005586 (UMLS CUI [5,1])
C4071830 (UMLS CUI [5,2])
C0033975 (UMLS CUI [6,1])
C4071830 (UMLS CUI [6,2])
C0030319 (UMLS CUI [7,1])
C4071830 (UMLS CUI [7,2])
C0003431 (UMLS CUI [8,1])
C4071830 (UMLS CUI [8,2])
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])
Laboratory test result abnormal
Item
patients with clinically significant abnormal laboratory value at screening
boolean
C0438215 (UMLS CUI [1])
Study Subject Participation Status | Evaluation Investigator
Item
the investigator will evaluate whether there are other reasons why a patient may not participate
boolean
C2348568 (UMLS CUI [1])
C1261322 (UMLS CUI [2,1])
C0035173 (UMLS CUI [2,2])
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