ID

36320

Beskrivning

Evaluation of the Safety of Adjunct Brexpiprazole in Elderly Patients With Major Depressive Disorder and an Inadequate Response to Antidepressant Treatment; ODM derived from: https://clinicaltrials.gov/show/NCT02400346

Länk

https://clinicaltrials.gov/show/NCT02400346

Nyckelord

Versioner (1)
  1. 2019-05-03 2019-05-03 -
Rättsinnehavare

See4 clinicaltrials.gov

Uppladdad den

3 maj 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Major Depression Disorder NCT02400346

Engelsk

Eligibility Major Depression Disorder NCT02400346

1 Formulär  
Criteria
Beskrivning

Criteria

• the patient is a man or woman aged ≥65 yrs
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
the patient has major depressive disorder according to diagnostic and statistical manual of mental disorders, 4th edition, text revision (dsm-iv-tr™).
Beskrivning

Major Depressive Disorder

Datatyp

boolean

Alias
UMLS CUI [1]
C1269683
the patient has an inadequate response to at least one adequate antidepressant treatment in the current major depressive episode (mde).
Beskrivning

Antidepressant therapy Major depressive episode | Response Inadequate

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1096649
UMLS CUI [1,2]
C0024517
UMLS CUI [2,1]
C1704632
UMLS CUI [2,2]
C0205412
the patient has had the current mde for ≥8 weeks
Beskrivning

Major depressive episode Duration

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0024517
UMLS CUI [1,2]
C0449238
the patient is currently treated with a protocol specified adt for at least 6 weeks
Beskrivning

Antidepressant therapy Study Protocol

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1096649
UMLS CUI [1,2]
C2348563
the patient is judged to benefit from adjunctive treatment with brexpiprazole according to the clinical opinion of the investigator.
Beskrivning

brexpiprazole

Datatyp

boolean

Alias
UMLS CUI [1]
C3885614
montgomery and åsberg depression rating scale (madrs) total score > 18 at screening and baseline
Beskrivning

Montgomery-Asberg Depression Rating Scale Questionnaire

Datatyp

boolean

Alias
UMLS CUI [1]
C4054475
clinical global impression - severity (cgi-s) total score ≥3 at screening and baseline
Beskrivning

CGI - Severity of Illness

Datatyp

boolean

Alias
UMLS CUI [1]
C3639887
main exclusion criteria:
Beskrivning

Exclusion Criteria Main

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1542147
• the patient has a clinically significant unstable illness
Beskrivning

Illness Unstable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0443343
the patient has newly diagnosed or unstable diabetes
Beskrivning

Diabetes Mellitus Newly Diagnosed | Unstable diabetes mellitus

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0011849
UMLS CUI [1,2]
C1518321
UMLS CUI [2]
C0342302
the patient has a mini mental state exam (mmse) score <24
Beskrivning

Mini-mental state examination

Datatyp

boolean

Alias
UMLS CUI [1]
C0451306
the patient has received transcranial magnetic stimulation (tms) and/or electroconvulsive therapy (ect) less than 6 months prior to the screening.
Beskrivning

Transcranial magnetic stimulation | Electroconvulsive Therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0436548
UMLS CUI [2]
C0013806
the patient, in the opinion of the investigator or based on columbia-suicide severity rating scale (c-ssrs) suicidal ideation and behaviour rating, is at significant risk of suicide
Beskrivning

At risk for suicide Columbia suicide severity rating scale

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0563664
UMLS CUI [1,2]
C3888485
other protocol defined inclusion and exclusion criteria may apply
Beskrivning

Eligibility Criteria Study Protocol

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348563
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Similar models

Eligibility Major Depression Disorder NCT02400346

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Age
Item
• the patient is a man or woman aged ≥65 yrs
boolean
C0001779 (UMLS CUI [1])
Major Depressive Disorder
Item
the patient has major depressive disorder according to diagnostic and statistical manual of mental disorders, 4th edition, text revision (dsm-iv-tr™).
boolean
C1269683 (UMLS CUI [1])
Antidepressant therapy Major depressive episode | Response Inadequate
Item
the patient has an inadequate response to at least one adequate antidepressant treatment in the current major depressive episode (mde).
boolean
C1096649 (UMLS CUI [1,1])
C0024517 (UMLS CUI [1,2])
C1704632 (UMLS CUI [2,1])
C0205412 (UMLS CUI [2,2])
Major depressive episode Duration
Item
the patient has had the current mde for ≥8 weeks
boolean
C0024517 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Antidepressant therapy Study Protocol
Item
the patient is currently treated with a protocol specified adt for at least 6 weeks
boolean
C1096649 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
brexpiprazole
Item
the patient is judged to benefit from adjunctive treatment with brexpiprazole according to the clinical opinion of the investigator.
boolean
C3885614 (UMLS CUI [1])
Montgomery-Asberg Depression Rating Scale Questionnaire
Item
montgomery and åsberg depression rating scale (madrs) total score > 18 at screening and baseline
boolean
C4054475 (UMLS CUI [1])
CGI - Severity of Illness
Item
clinical global impression - severity (cgi-s) total score ≥3 at screening and baseline
boolean
C3639887 (UMLS CUI [1])
Exclusion Criteria Main
Item
main exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Illness Unstable
Item
• the patient has a clinically significant unstable illness
boolean
C0221423 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
Diabetes Mellitus Newly Diagnosed | Unstable diabetes mellitus
Item
the patient has newly diagnosed or unstable diabetes
boolean
C0011849 (UMLS CUI [1,1])
C1518321 (UMLS CUI [1,2])
C0342302 (UMLS CUI [2])
Mini-mental state examination
Item
the patient has a mini mental state exam (mmse) score <24
boolean
C0451306 (UMLS CUI [1])
Transcranial magnetic stimulation | Electroconvulsive Therapy
Item
the patient has received transcranial magnetic stimulation (tms) and/or electroconvulsive therapy (ect) less than 6 months prior to the screening.
boolean
C0436548 (UMLS CUI [1])
C0013806 (UMLS CUI [2])
At risk for suicide Columbia suicide severity rating scale
Item
the patient, in the opinion of the investigator or based on columbia-suicide severity rating scale (c-ssrs) suicidal ideation and behaviour rating, is at significant risk of suicide
boolean
C0563664 (UMLS CUI [1,1])
C3888485 (UMLS CUI [1,2])
Eligibility Criteria Study Protocol
Item
other protocol defined inclusion and exclusion criteria may apply
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
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