ID

20547

Description

A 24-52-week Study to Evaluate the Long-term Efficacy and Safety of Saredutant in Patients With Depression (MAGENTA); ODM derived from: https://clinicaltrials.gov/show/NCT00336713

Link

https://clinicaltrials.gov/show/NCT00336713

Keywords

Versions (1)
  1. 3/2/17 3/2/17 -
Uploaded on

March 2, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Depressive Disorder NCT00336713

English

Eligibility Depressive Disorder NCT00336713

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of major depressive disorder, as defined by dsm-iv criteria and confirmed by the semi-structured mini international neuropsychiatric interview (mini), recurrent episode.
Description

Major Depressive Disorder | Recurrent major depressive episodes

Data type

boolean

Alias
UMLS CUI [1]
C1269683
UMLS CUI [2]
C0154409
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
total score of 28 or less on the montgomery and asberg depression rating scale (madrs).
Description

Montgomery-Asberg Depression Rating Scale Questionnaire

Data type

boolean

Alias
UMLS CUI [1]
C4054475
clinical global impression (cgi) severity score of less than 4.
Description

Clinical Global Impression Questionnaire

Data type

boolean

Alias
UMLS CUI [1]
C3639708
duration of the current depressive episode less than 2 months or greater than 2 years.
Description

Depressive episode Duration

Data type

boolean

Alias
UMLS CUI [1,1]
C0349217
UMLS CUI [1,2]
C0449238
elderly patients with a mini-mental state examination (mmse) total score <25.
Description

Patients Elderly Mini-mental state examination

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0001792
UMLS CUI [1,3]
C0451306
patients with a history or presence of bipolar disorders or psychotic disorders.
Description

Bipolar Disorder | Psychotic Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0005586
UMLS CUI [2]
C0033975
patients with alcohol dependence or abuse or substance dependence or abuse in the past 12 months 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
benzodiazepine or sedative-hypnotic use greater than 2 days per week during the month prior to entry into the acute phase.
Description

Benzodiazepines days/week | Sedative hypnotics days/week

Data type

boolean

Alias
UMLS CUI [1,1]
C0005064
UMLS CUI [1,2]
C0677547
UMLS CUI [2,1]
C3854290
UMLS CUI [2,2]
C0677547
patients who have used the following prior to entry into acute phase: antipsychotics within 3 months, fluoxetine within 1 month, maois within 2 weeks, other antidepressant or mood-stabilizer (lithium, anticonvulsants) within 1 week.
Description

Antipsychotic Agents | Fluoxetine | Monoamine Oxidase Inhibitors | Antidepressive Agents | 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]
C2917435
UMLS CUI [6]
C3540800
UMLS CUI [7]
C0003286
the investigator will evaluate whether there are other reasons why a patient may not participate.
Description

Study Subject Participation Status | Evaluation Investigator

Data type

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 NCT00336713

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Major Depressive Disorder | Recurrent major depressive episodes
Item
diagnosis of major depressive disorder, as defined by dsm-iv criteria and confirmed by the semi-structured mini international neuropsychiatric interview (mini), recurrent episode.
boolean
C1269683 (UMLS CUI [1])
C0154409 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Montgomery-Asberg Depression Rating Scale Questionnaire
Item
total score of 28 or less on the montgomery and asberg depression rating scale (madrs).
boolean
C4054475 (UMLS CUI [1])
Clinical Global Impression Questionnaire
Item
clinical global impression (cgi) severity score of less than 4.
boolean
C3639708 (UMLS CUI [1])
Depressive episode Duration
Item
duration of the current depressive episode less than 2 months or greater than 2 years.
boolean
C0349217 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Patients Elderly Mini-mental state examination
Item
elderly patients with a mini-mental state examination (mmse) total score <25.
boolean
C0030705 (UMLS CUI [1,1])
C0001792 (UMLS CUI [1,2])
C0451306 (UMLS CUI [1,3])
Bipolar Disorder | Psychotic Disorders
Item
patients with a history or presence of bipolar disorders or psychotic disorders.
boolean
C0005586 (UMLS CUI [1])
C0033975 (UMLS CUI [2])
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 except nicotine or caffeine dependence.
boolean
C0038580 (UMLS CUI [1])
C0038586 (UMLS CUI [2])
C0028043 (UMLS CUI [3])
C1386553 (UMLS CUI [4])
Benzodiazepines days/week | Sedative hypnotics days/week
Item
benzodiazepine or sedative-hypnotic use greater than 2 days per week during the month prior to entry into the acute phase.
boolean
C0005064 (UMLS CUI [1,1])
C0677547 (UMLS CUI [1,2])
C3854290 (UMLS CUI [2,1])
C0677547 (UMLS CUI [2,2])
Antipsychotic Agents | Fluoxetine | Monoamine Oxidase Inhibitors | Antidepressive Agents | Mood Stabilizer | Lithium | Anticonvulsants
Item
patients who have used the following prior to entry into acute phase: antipsychotics within 3 months, fluoxetine within 1 month, maois within 2 weeks, other antidepressant or mood-stabilizer (lithium, anticonvulsants) within 1 week.
boolean
C0040615 (UMLS CUI [1])
C0016365 (UMLS CUI [2])
C0026457 (UMLS CUI [3])
C0003289 (UMLS CUI [4])
C2917435 (UMLS CUI [5])
C3540800 (UMLS CUI [6])
C0003286 (UMLS CUI [7])
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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