ID

20551

Beschrijving

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

Trefwoorden

  1. 02-03-17 02-03-17 -
Geüploaded op

2 maart 2017

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Depressive Disorder NCT00361491

Eligibility Depressive Disorder NCT00361491

Inclusion Criteria
Beschrijving

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)
Beschrijving

Major Depressive Disorder Recurrent

Datatype

boolean

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

Exclusion Criteria

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

Montgomery-Asberg Depression Rating Scale Questionnaire

Datatype

boolean

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

Hamilton rating scale for depression

Datatype

boolean

Alias
UMLS CUI [1]
C0451203
duration of the current depressive episode less than 1 month or greater than 2 years.
Beschrijving

Depressive episode Duration

Datatype

boolean

Alias
UMLS CUI [1,1]
C0349217
UMLS CUI [1,2]
C0449238
patients with a history or presence of bipolar disorders or psychotic disorders.
Beschrijving

Bipolar Disorder | Psychotic Disorders

Datatype

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.
Beschrijving

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

Datatype

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.
Beschrijving

Antipsychotic Agents | Fluoxetine | Monoamine Oxidase Inhibitors | Antidepressive Agents | Mood Stabilizer | Lithium | Anticonvulsants

Datatype

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
Beschrijving

Study Subject Participation Status | Evaluation Investigator

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C1261322
UMLS CUI [2,2]
C0035173

Similar models

Eligibility Depressive Disorder NCT00361491

Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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