ID

28908

Description

A Study Evaluating the Safety and Tolerability of Abrupt Discontinuation of Saredutant in Patients With Depression; ODM derived from: https://clinicaltrials.gov/show/NCT00429260

Link

https://clinicaltrials.gov/show/NCT00429260

Keywords

Versions (1)
  1. 2/14/18 2/14/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 14, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Depressive Disorder NCT00429260

English

Eligibility Depressive Disorder NCT00429260

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of major depressive disorder,single or recurrent episode, as defined by diagnostic and statistical manual of mental disorders dsm-iv criteria
Description

Major Depressive Disorder | Single major depressive episode | Recurrent major depressive episodes

Data type

boolean

Alias
UMLS CUI [1]
C1269683
UMLS CUI [2]
C0024517
UMLS CUI [3]
C0154409
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
total score of <22 on the montgomery-asberg depression rating scale (madrs).
Description

Montgomery-Asberg Depression Rating Scale Questionnaire

Data type

boolean

Alias
UMLS CUI [1]
C4054475
duration of the current depressive episode is less than 1 month or greater than 2 years.
Description

Depressive episode Duration

Data type

boolean

Alias
UMLS CUI [1,1]
C0349217
UMLS CUI [1,2]
C0449238
total score of <25 on the mini mental state examination (elderly patients ≥65 years only).
Description

Mini-mental state examination | Elderly

Data type

boolean

Alias
UMLS CUI [1]
C0451306
UMLS CUI [2]
C0001792
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 6 months except nicotine or caffeine dependence.
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C0038580
UMLS CUI [2]
C0038586
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0028043
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C1386553
patients who have used the following prior to entry: benzodiazepines or sedative-hypnotics more than 2 days per week within 1 month, antipsychotics within 1 month, fluoxetine within 1 month, monoamine oxidase inhibitors within 2 weeks, other antidepressants, anxiolytics, or mood-stabilizer (lithium, anticonvulsants) within 1 week.
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C0005064
UMLS CUI [2]
C0020592
UMLS CUI [3]
C0040615
UMLS CUI [4]
C0016365
UMLS CUI [5]
C0026457
UMLS CUI [6]
C0003289
UMLS CUI [7]
C0040616
UMLS CUI [8]
C2917435
UMLS CUI [9]
C0023870
UMLS CUI [10]
C0003286
the investigator will evaluate whether there are other reasons why a patient may not participate.
Description

Other Reason Study Subject Participation Status Unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C3840932
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C0558080
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Similar models

Eligibility Depressive Disorder NCT00429260

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Major Depressive Disorder | Single major depressive episode | Recurrent major depressive episodes
Item
diagnosis of major depressive disorder,single or recurrent episode, as defined by diagnostic and statistical manual of mental disorders dsm-iv criteria
boolean
C1269683 (UMLS CUI [1])
C0024517 (UMLS CUI [2])
C0154409 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Montgomery-Asberg Depression Rating Scale Questionnaire
Item
total score of <22 on the montgomery-asberg depression rating scale (madrs).
boolean
C4054475 (UMLS CUI [1])
Depressive episode Duration
Item
duration of the current depressive episode is less than 1 month or greater than 2 years.
boolean
C0349217 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Mini-mental state examination | Elderly
Item
total score of <25 on the mini mental state examination (elderly patients ≥65 years only).
boolean
C0451306 (UMLS CUI [1])
C0001792 (UMLS CUI [2])
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 | Exception Nicotine Dependence | Exception Caffeine dependence
Item
patients with alcohol dependence or abuse or substance dependence or abuse in the past 6 months except nicotine or caffeine dependence.
boolean
C0038580 (UMLS CUI [1])
C0038586 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0028043 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C1386553 (UMLS CUI [4,2])
Benzodiazepines | Hypnotics and Sedatives | Antipsychotic Agents | Fluoxetine | Monoamine Oxidase Inhibitors | Antidepressive Agents | Anti-Anxiety Agents | Mood Stabilizer | Lithium | Anticonvulsants
Item
patients who have used the following prior to entry: benzodiazepines or sedative-hypnotics more than 2 days per week within 1 month, antipsychotics within 1 month, fluoxetine within 1 month, monoamine oxidase inhibitors within 2 weeks, other antidepressants, anxiolytics, or mood-stabilizer (lithium, anticonvulsants) within 1 week.
boolean
C0005064 (UMLS CUI [1])
C0020592 (UMLS CUI [2])
C0040615 (UMLS CUI [3])
C0016365 (UMLS CUI [4])
C0026457 (UMLS CUI [5])
C0003289 (UMLS CUI [6])
C0040616 (UMLS CUI [7])
C2917435 (UMLS CUI [8])
C0023870 (UMLS CUI [9])
C0003286 (UMLS CUI [10])
Other Reason Study Subject Participation Status Unwilling
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])
C0558080 (UMLS CUI [1,3])
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