ID

34251

Description

Efficacy and Safety of Flexibly Dosed BMS-820836 in the Treatment of Patients With Treatment Resistant Major Depression; ODM derived from: https://clinicaltrials.gov/show/NCT01309945

Link

https://clinicaltrials.gov/show/NCT01309945

Keywords

  1. 1/16/19 1/16/19 -
Copyright Holder

see on clinicaltrials.gov

Uploaded on

January 16, 2019

DOI

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License

Creative Commons BY 4.0

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Eligibility Depression NCT01309945

Eligibility Depression NCT01309945

  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT01309945
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients must be able to understand the nature of the study, agree to comply with the prescribed dosage regimens, report for regularly scheduled office visits, and communicate to study personnel about adverse events and concomitant medication use.
Description

ID.1

Data type

boolean

patients with a diagnosis of major depressive disorder, currently experiencing a major depressive episode, as defined by diagnostic and statistical manual of mental disorders- fourth edition text revision(dsm iv tr) criteria. the current depressive episode must be > 8 weeks in duration and < 3 years duration.
Description

ID.2

Data type

boolean

in the current major depressive disorder (mdd) episode, patients should report a history of inadequate response to 1 - 3 adequate trials of antidepressant treatment.
Description

ID.3

Data type

boolean

patients must have a 17-item hamilton depression rating scale (ham-d17) total score =>18 at screening.
Description

ID.4

Data type

boolean

Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who report an inadequate response (less than 50% reduction in depressive symptom severity) to more than three adequate trials of antidepressant treatments during the current depressive episode.
Description

ID.5

Data type

boolean

patients who have failed duloxetine at an adequate dose and for an adequate duration in their current episode unless in the judgment of the investigator, the patient could benefit from the treatment with this medication.
Description

ID.6

Data type

boolean

patients whose only inadequate response to an antidepressant in the current major depressive episode (mde) is to an serotonin norepinephrine reuptake inhibitors (snri) (duloxetine, venlafaxine, desvenlafaxine or milnacipran).
Description

ID.7

Data type

boolean

Similar models

Eligibility Depression NCT01309945

  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT01309945
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
ID.1
Item
patients must be able to understand the nature of the study, agree to comply with the prescribed dosage regimens, report for regularly scheduled office visits, and communicate to study personnel about adverse events and concomitant medication use.
boolean
ID.2
Item
patients with a diagnosis of major depressive disorder, currently experiencing a major depressive episode, as defined by diagnostic and statistical manual of mental disorders- fourth edition text revision(dsm iv tr) criteria. the current depressive episode must be > 8 weeks in duration and < 3 years duration.
boolean
ID.3
Item
in the current major depressive disorder (mdd) episode, patients should report a history of inadequate response to 1 - 3 adequate trials of antidepressant treatment.
boolean
ID.4
Item
patients must have a 17-item hamilton depression rating scale (ham-d17) total score =>18 at screening.
boolean
Item Group
C0680251 (UMLS CUI)
ID.5
Item
patients who report an inadequate response (less than 50% reduction in depressive symptom severity) to more than three adequate trials of antidepressant treatments during the current depressive episode.
boolean
ID.6
Item
patients who have failed duloxetine at an adequate dose and for an adequate duration in their current episode unless in the judgment of the investigator, the patient could benefit from the treatment with this medication.
boolean
ID.7
Item
patients whose only inadequate response to an antidepressant in the current major depressive episode (mde) is to an serotonin norepinephrine reuptake inhibitors (snri) (duloxetine, venlafaxine, desvenlafaxine or milnacipran).
boolean

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