ID

20548

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT00345098

Nyckelord

Versioner (1)
  1. 2017-03-02 2017-03-02 -
Uppladdad den

2 mars 2017

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Depressive Disorder NCT00345098

Engelsk

Eligibility Depressive Disorder NCT00345098

1 Formulär  
Inclusion Criteria
Beskrivning

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)
Beskrivning

Major Depressive Disorder Recurrent

Datatyp

boolean

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

Montgomery-Asberg Depression Rating Scale Questionnaire

Datatyp

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
Beskrivning

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

Datatyp

boolean

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

Exclusion Criteria

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

At risk for suicide

Datatyp

boolean

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

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

Datatyp

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.
Beskrivning

Depressive episode Secondary to Medical condition General

Datatyp

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.
Beskrivning

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

Datatyp

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
Beskrivning

Comorbidity Severe | Comorbidity Unstable

Datatyp

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
Beskrivning

Laboratory test result abnormal

Datatyp

boolean

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

Study Subject Participation Status | Evaluation Investigator

Datatyp

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 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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