ID

20551

Description

An Eight-Week Study Evaluating the Efficacy of Two Fixed Doses (250 mg Twice Daily and 100 mg Twice Daily) of SSR149415 in Patients With Major Depressive Disorder; ODM derived from: https://clinicaltrials.gov/show/NCT00361491

Link

https://clinicaltrials.gov/show/NCT00361491

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 NCT00361491

English

Eligibility Depressive Disorder NCT00361491

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of major depressive disorder, recurrent, as defined by diagnostic and statistical manual of mental disorders, 4th edition, text revision (dsm-iv-tr) criteria (296.3) and confirmed by the semi-structured mini international neuropsychiatric interview (mini)
Description

Major Depressive Disorder Recurrent

Data type

boolean

Alias
UMLS CUI [1,1]
C1269683
UMLS CUI [1,2]
C2945760
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
total score of less than 24 on the madrs.
Description

Montgomery-Asberg Depression Rating Scale Questionnaire

Data type

boolean

Alias
UMLS CUI [1]
C4054475
ham-d total score less than 18.
Description

Hamilton rating scale for depression

Data type

boolean

Alias
UMLS CUI [1]
C0451203
duration of the current depressive episode 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
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
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 antidepressants, 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 NCT00361491

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Major Depressive Disorder Recurrent
Item
diagnosis of major depressive disorder, recurrent, as defined by diagnostic and statistical manual of mental disorders, 4th edition, text revision (dsm-iv-tr) criteria (296.3) and confirmed by the semi-structured mini international neuropsychiatric interview (mini)
boolean
C1269683 (UMLS CUI [1,1])
C2945760 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Montgomery-Asberg Depression Rating Scale Questionnaire
Item
total score of less than 24 on the madrs.
boolean
C4054475 (UMLS CUI [1])
Hamilton rating scale for depression
Item
ham-d total score less than 18.
boolean
C0451203 (UMLS CUI [1])
Depressive episode Duration
Item
duration of the current depressive episode less than 1 month or greater than 2 years.
boolean
C0349217 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
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 | 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])
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 antidepressants, 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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