ID

20542

Descripción

An Eight-Week Study to Evaluate the Efficacy and Safety of SR58611A in Elderly Patients With Depression; ODM derived from: https://clinicaltrials.gov/show/NCT00319709

Link

https://clinicaltrials.gov/show/NCT00319709

Palabras clave

Versiones (2)
  1. 2/3/17 2/3/17 -
  2. 2/3/17 2/3/17 -
Subido en

2 de marzo de 2017

DOI

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Licencia

Creative Commons BY-NC 3.0
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Eligibility Depressive Disorder NCT00319709

Inglés

Eligibility Depressive Disorder NCT00319709

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
outpatients or inpatients
Descripción

Outpatients | inpatient

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0029921
UMLS CUI [2]
C0021562
major depressive disorder (mdd) with a recurrent major depressive episode (mde) according to dsm iv-tr criteria.
Descripción

Major Depressive Disorder | Recurrent major depressive episode

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1269683
UMLS CUI [2]
C0154409
madrs score equal of above 22.
Descripción

Montgomery-Asberg Depression Rating Scale Questionnaire

Tipo de datos

boolean

Alias
UMLS CUI [1]
C4054475
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with a current significant risk of suicide in the investigator's clinical judgment.
Descripción

At risk for suicide

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0563664
the duration of the current depressive episode is greater than 2 years.
Descripción

Depressive episode Duration

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0349217
UMLS CUI [1,2]
C0449238
patients whose current depressive episode is secondary to a general medical condition
Descripción

Depressive episode Secondary to Medical condition General

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0349217
UMLS CUI [1,2]
C0175668
UMLS CUI [1,3]
C3843040
UMLS CUI [1,4]
C0205246
patients with a lifetime history according to mini at screening of:bipolar disorder, psychotic disorder, antisocial personality disorder.
Descripción

Bipolar Disorder Lifetime Mini-mental state examination score | Psychotic Disorder Lifetime Mini-mental state examination score | Antisocial Personality Disorder Lifetime Mini-mental state examination score

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0005586
UMLS CUI [1,2]
C4071830
UMLS CUI [1,3]
C2960235
UMLS CUI [2,1]
C0033975
UMLS CUI [2,2]
C4071830
UMLS CUI [2,3]
C2960235
UMLS CUI [3,1]
C0003431
UMLS CUI [3,2]
C4071830
UMLS CUI [3,3]
C2960235
patients with a current history according to mini at screening of anxiety disorders, alcohol dependence or abuse or substance dependence or abuse
Descripción

Anxiety Disorder Mini-mental state examination score | Substance Dependence Mini-mental state examination score | Substance Use Disorders Mini-mental state examination score

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0003469
UMLS CUI [1,2]
C2960235
UMLS CUI [2,1]
C0038580
UMLS CUI [2,2]
C2960235
UMLS CUI [3,1]
C0038586
UMLS CUI [3,2]
C2960235
patients with severe or unstable concomitant medical conditions.
Descripción

Comorbidity Severe | Comorbidity Unstable

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0443343
history of seizures other than a single childhood febrile seizure.
Descripción

Seizures | Childhood seizure febrile single

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0036572
UMLS CUI [2,1]
C2733190
UMLS CUI [2,2]
C0015967
UMLS CUI [2,3]
C0205171
patients with abnormal thyroid functioning.
Descripción

thyroid function abnormal

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2242456
UMLS CUI [1,2]
C0205161
patients with clinically significant ecg findings at screening.
Descripción

ECG finding Clinical Significance

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0438154
UMLS CUI [1,2]
C2826293
patients who have taken an investigational drug in the last 3 months prior to screening.
Descripción

Investigational New Drugs

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0013230
any subject who has previously participated in a sr58611a protocol.
Descripción

Study Subject Participation Status | amibegron

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C2698085
patients with mini-mental state examination (mmse) score < 25 at screening.
Descripción

Mini-mental state examination score

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2960235
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Similar models

Eligibility Depressive Disorder NCT00319709

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Outpatients | inpatient
Item
outpatients or inpatients
boolean
C0029921 (UMLS CUI [1])
C0021562 (UMLS CUI [2])
Major Depressive Disorder | Recurrent major depressive episode
Item
major depressive disorder (mdd) with a recurrent major depressive episode (mde) according to dsm iv-tr criteria.
boolean
C1269683 (UMLS CUI [1])
C0154409 (UMLS CUI [2])
Montgomery-Asberg Depression Rating Scale Questionnaire
Item
madrs score equal of above 22.
boolean
C4054475 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
At risk for suicide
Item
patients with a current significant risk of suicide in the investigator's clinical judgment.
boolean
C0563664 (UMLS CUI [1])
Depressive episode Duration
Item
the duration of the current depressive episode is greater than 2 years.
boolean
C0349217 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Depressive episode Secondary to Medical condition General
Item
patients whose current depressive episode is secondary to a general medical condition
boolean
C0349217 (UMLS CUI [1,1])
C0175668 (UMLS CUI [1,2])
C3843040 (UMLS CUI [1,3])
C0205246 (UMLS CUI [1,4])
Bipolar Disorder Lifetime Mini-mental state examination score | Psychotic Disorder Lifetime Mini-mental state examination score | Antisocial Personality Disorder Lifetime Mini-mental state examination score
Item
patients with a lifetime history according to mini at screening of:bipolar disorder, psychotic disorder, antisocial personality disorder.
boolean
C0005586 (UMLS CUI [1,1])
C4071830 (UMLS CUI [1,2])
C2960235 (UMLS CUI [1,3])
C0033975 (UMLS CUI [2,1])
C4071830 (UMLS CUI [2,2])
C2960235 (UMLS CUI [2,3])
C0003431 (UMLS CUI [3,1])
C4071830 (UMLS CUI [3,2])
C2960235 (UMLS CUI [3,3])
Anxiety Disorder Mini-mental state examination score | Substance Dependence Mini-mental state examination score | Substance Use Disorders Mini-mental state examination score
Item
patients with a current history according to mini at screening of anxiety disorders, alcohol dependence or abuse or substance dependence or abuse
boolean
C0003469 (UMLS CUI [1,1])
C2960235 (UMLS CUI [1,2])
C0038580 (UMLS CUI [2,1])
C2960235 (UMLS CUI [2,2])
C0038586 (UMLS CUI [3,1])
C2960235 (UMLS CUI [3,2])
Comorbidity Severe | Comorbidity Unstable
Item
patients with severe or unstable concomitant medical conditions.
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0009488 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
Seizures | Childhood seizure febrile single
Item
history of seizures other than a single childhood febrile seizure.
boolean
C0036572 (UMLS CUI [1])
C2733190 (UMLS CUI [2,1])
C0015967 (UMLS CUI [2,2])
C0205171 (UMLS CUI [2,3])
thyroid function abnormal
Item
patients with abnormal thyroid functioning.
boolean
C2242456 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
ECG finding Clinical Significance
Item
patients with clinically significant ecg findings at screening.
boolean
C0438154 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
Investigational New Drugs
Item
patients who have taken an investigational drug in the last 3 months prior to screening.
boolean
C0013230 (UMLS CUI [1])
Study Subject Participation Status | amibegron
Item
any subject who has previously participated in a sr58611a protocol.
boolean
C2348568 (UMLS CUI [1])
C2698085 (UMLS CUI [2])
Mini-mental state examination score
Item
patients with mini-mental state examination (mmse) score < 25 at screening.
boolean
C2960235 (UMLS CUI [1])
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