ID

21824

Description

Evaluation of the Potential Effects of SSR149415 on the Hypothalamic-pituitary-adrenal Axis in Outpatients With Major Depressive Disorder; ODM derived from: https://clinicaltrials.gov/show/NCT01606384

Link

https://clinicaltrials.gov/show/NCT01606384

Keywords

Versions (1)
  1. 5/2/17 5/2/17 -
Uploaded on

May 2, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Major Depressive Disorder NCT01606384

English

Eligibility Major Depressive Disorder NCT01606384

1 forms  
Criteria
Description

Criteria

diagnosis of major depressive disorder as defined by the diagnostic and statistical manual of mental disorders, 4th edition-text revision (dsm-iv-tr) and the mini international neuropsychiatric interview (mini) criteria.
Description

Major Depressive Disorder

Data type

boolean

Alias
UMLS CUI [1]
C1269683
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
outpatients unwilling to be hospitalized a total of 6 nights and 8 days.
Description

Outpatients | Hospitalization Duration Unwilling

Data type

boolean

Alias
UMLS CUI [1]
C0029921
UMLS CUI [2,1]
C0019993
UMLS CUI [2,2]
C0449238
UMLS CUI [2,3]
C0558080
total score of less than 21 (<21) on the 17-item hamilton depression rating scale (ham-d) at visit 1 (day -7) or visit 5 (day -1).
Description

Hamilton Depression Rating Scale 17 Item Questionnaire

Data type

boolean

Alias
UMLS CUI [1]
C3639712
patients whose current depressive episode is diagnosed with psychotic features, catatonic features, seasonal pattern or post-partum onset or is secondary to a general medical disorder.
Description

Depressive episode | Psychotic symptom | Feature Catatonic | Seasonal Affective Disorder | Depression, Postpartum | Depressive episode Secondary to Disease General

Data type

boolean

Alias
UMLS CUI [1]
C0349217
UMLS CUI [2]
C0871189
UMLS CUI [3,1]
C2348519
UMLS CUI [3,2]
C0007398
UMLS CUI [4]
C0085159
UMLS CUI [5]
C0221074
UMLS CUI [6,1]
C0349217
UMLS CUI [6,2]
C0175668
UMLS CUI [6,3]
C0012634
UMLS CUI [6,4]
C0205246
patients with alcohol dependence or abuse or substance dependence or abuse in the past 12 months according to the mini, except nicotine or caffeine dependence.
Description

Substance Dependence | Substance Use Disorders | Nicotine Dependence | Caffeine dependence

Data type

boolean

Alias
UMLS CUI [1]
C0038580
UMLS CUI [2]
C0038586
UMLS CUI [3]
C0028043
UMLS CUI [4]
C1386553
patients who have used the following prior to entry into segment b: any antipsychotic within 3 months; fluoxetine within 1 month; any monoamine oxidase inhibitor (maoi) within 2 weeks; any other antidepressant, anxiolytic, sedative-hypnotic, or mood-stabilizer (lithium, anticonvulsants) within 7 days except permitted concomitant medications
Description

Antipsychotic Agents | Fluoxetine | Monoamine Oxidase Inhibitors | Antidepressive Agents | Anti-Anxiety Agents | Hypnotics and Sedatives | Mood Stabilizer | Lithium | Anticonvulsants

Data type

boolean

Alias
UMLS CUI [1]
C0040615
UMLS CUI [2]
C0016365
UMLS CUI [3]
C0026457
UMLS CUI [4]
C0003289
UMLS CUI [5]
C0040616
UMLS CUI [6]
C0020592
UMLS CUI [7]
C2917435
UMLS CUI [8]
C0023870
UMLS CUI [9]
C0003286
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
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Similar models

Eligibility Major Depressive Disorder NCT01606384

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Major Depressive Disorder
Item
diagnosis of major depressive disorder as defined by the diagnostic and statistical manual of mental disorders, 4th edition-text revision (dsm-iv-tr) and the mini international neuropsychiatric interview (mini) criteria.
boolean
C1269683 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Outpatients | Hospitalization Duration Unwilling
Item
outpatients unwilling to be hospitalized a total of 6 nights and 8 days.
boolean
C0029921 (UMLS CUI [1])
C0019993 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
Hamilton Depression Rating Scale 17 Item Questionnaire
Item
total score of less than 21 (<21) on the 17-item hamilton depression rating scale (ham-d) at visit 1 (day -7) or visit 5 (day -1).
boolean
C3639712 (UMLS CUI [1])
Depressive episode | Psychotic symptom | Feature Catatonic | Seasonal Affective Disorder | Depression, Postpartum | Depressive episode Secondary to Disease General
Item
patients whose current depressive episode is diagnosed with psychotic features, catatonic features, seasonal pattern or post-partum onset or is secondary to a general medical disorder.
boolean
C0349217 (UMLS CUI [1])
C0871189 (UMLS CUI [2])
C2348519 (UMLS CUI [3,1])
C0007398 (UMLS CUI [3,2])
C0085159 (UMLS CUI [4])
C0221074 (UMLS CUI [5])
C0349217 (UMLS CUI [6,1])
C0175668 (UMLS CUI [6,2])
C0012634 (UMLS CUI [6,3])
C0205246 (UMLS CUI [6,4])
Substance Dependence | Substance Use Disorders | Nicotine Dependence | Caffeine dependence
Item
patients with alcohol dependence or abuse or substance dependence or abuse in the past 12 months according to the mini, except nicotine or caffeine dependence.
boolean
C0038580 (UMLS CUI [1])
C0038586 (UMLS CUI [2])
C0028043 (UMLS CUI [3])
C1386553 (UMLS CUI [4])
Antipsychotic Agents | Fluoxetine | Monoamine Oxidase Inhibitors | Antidepressive Agents | Anti-Anxiety Agents | Hypnotics and Sedatives | Mood Stabilizer | Lithium | Anticonvulsants
Item
patients who have used the following prior to entry into segment b: any antipsychotic within 3 months; fluoxetine within 1 month; any monoamine oxidase inhibitor (maoi) within 2 weeks; any other antidepressant, anxiolytic, sedative-hypnotic, or mood-stabilizer (lithium, anticonvulsants) within 7 days except permitted concomitant medications
boolean
C0040615 (UMLS CUI [1])
C0016365 (UMLS CUI [2])
C0026457 (UMLS CUI [3])
C0003289 (UMLS CUI [4])
C0040616 (UMLS CUI [5])
C0020592 (UMLS CUI [6])
C2917435 (UMLS CUI [7])
C0023870 (UMLS CUI [8])
C0003286 (UMLS CUI [9])
Study Subject Participation Status
Item
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
boolean
C2348568 (UMLS CUI [1])
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