ID

20545

Description

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

Keywords

Versions (2)
  1. 3/2/17 3/2/17 -
  2. 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 NCT00319709

English

Eligibility Depressive Disorder NCT00319709

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
outpatients or inpatients
Description

Outpatients | inpatient

Data type

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.
Description

Major Depressive Disorder | Recurrent major depressive episode

Data type

boolean

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

Montgomery-Asberg Depression Rating Scale Questionnaire

Data type

boolean

Alias
UMLS CUI [1]
C4054475
Exclusion Criteria
Description

Exclusion Criteria

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

At risk for suicide

Data type

boolean

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

Depressive episode Duration

Data type

boolean

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

Depressive episode Secondary to Medical condition General

Data type

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.
Description

Bipolar Disorder Lifetime | Psychotic Disorder Lifetime | Antisocial Personality Disorder Lifetime

Data type

boolean

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

Anxiety Disorder | Substance Dependence | Substance Use Disorders

Data type

boolean

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

Comorbidity Severe | Comorbidity Unstable

Data type

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.
Description

Seizures | Childhood seizure febrile single

Data type

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.
Description

thyroid function abnormal

Data type

boolean

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

ECG finding Clinical Significance

Data type

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.
Description

Investigational New Drugs

Data type

boolean

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

Study Subject Participation Status | amibegron

Data type

boolean

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

Mini-mental state examination score

Data type

boolean

Alias
UMLS CUI [1]
C2960235
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Similar models

Eligibility Depressive Disorder NCT00319709

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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 | Psychotic Disorder Lifetime | Antisocial Personality Disorder Lifetime
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])
C0033975 (UMLS CUI [2,1])
C4071830 (UMLS CUI [2,2])
C0003431 (UMLS CUI [3,1])
C4071830 (UMLS CUI [3,2])
Anxiety Disorder | Substance Dependence | Substance Use Disorders
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])
C0038580 (UMLS CUI [2])
C0038586 (UMLS CUI [3])
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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