ID

16907

Description

Efficacy and Safety of SR58611A in Patients With Major Depressive Disorder; ODM derived from: https://clinicaltrials.gov/show/NCT00252330

Link

https://clinicaltrials.gov/show/NCT00252330

Keywords

  1. 8/13/16 8/13/16 -
Uploaded on

August 13, 2016

DOI

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License

Creative Commons BY 4.0

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Eligibility Major Depressive Disorder NCT00252330

Eligibility Major Depressive Disorder NCT00252330

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
main inclusion criteria:
Description

Inclusion criteria

Data type

boolean

Alias
UMLS CUI [1]
C1512693
1. out-patients, 18 year and older.
Description

Out-patients, age

Data type

boolean

Alias
UMLS CUI [1]
C0029921
UMLS CUI [2]
C0001779
2. major depressive disorder (mdd) with a recurrentmajor depressive episode (mde) according to dsmiv-tr criteria
Description

major depressive disorder with a recurrent major depressive episode according to dsmiv-tr criteria

Data type

boolean

Alias
UMLS CUI [1,1]
C0154409
UMLS CUI [1,2]
C0220952
3. duration of current episode is at least of 6 weeksunless severity of symptoms justifies shorter duration.
Description

Duration of current depressive episode

Data type

boolean

Alias
UMLS CUI [1,1]
C0154409
UMLS CUI [1,2]
C0449238
4. patients have been treated or hospitalized for aprevious episode, or a previous episode requiredantidepressant treatment(s) at the recommended doselevel for a continuous total duration of at least 2months.
Description

Treatment or hospitalization or antidepressant treatment for a previous depressive episode

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0154409
UMLS CUI [2]
C0003289
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
main exclusion criteria:
Description

Exclusion criteria

Data type

boolean

Alias
UMLS CUI [1]
C0680251
1. patients at immediate risk for suicidal behavior
Description

Suicidal

Data type

boolean

Alias
UMLS CUI [1]
C0438696
2. patients with a mde with psychotic features, catatonic features, seasonal pattern or postpartum onset
Description

Major depressive episode with psychotic features, catatonic features, seasonal pattern or postpartum onset

Data type

boolean

Alias
UMLS CUI [1]
C0154413
UMLS CUI [2]
C0520672
UMLS CUI [3]
C0085159
UMLS CUI [4]
C0221074
3. the duration of the current depressive episode is greater than 2 years
Description

Duration of current depressive episode

Data type

boolean

Alias
UMLS CUI [1,1]
C0154409
UMLS CUI [1,2]
C0449238
4. patients whose current depressive episode is secondary to a general medical condition
Description

Current depressive episode secondary to a general medical condition

Data type

boolean

Alias
UMLS CUI [1]
C0520619
5. patients with a lifetime history of (1) bipolar disorder, (2) psychotic disorder, (3) antisocial personality disorder
Description

Bipolar disorder, psychotic disorder, or antisocial personality disorder

Data type

boolean

Alias
UMLS CUI [1]
C0005586
UMLS CUI [2]
C0033975
UMLS CUI [3]
C0003431
6. patients who have received non-pharmacologic, somatic treatments for psychiatric disease
Description

Somatic treatments

Data type

boolean

Alias
UMLS CUI [1]
C0037646
7. patients who have initiated, stopped, or changed the frequency or nature of psychotherapy within 3 months prior to screening
Description

Psychotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0033968

Similar models

Eligibility Major Depressive Disorder NCT00252330

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Inclusion criteria
Item
main inclusion criteria:
boolean
C1512693 (UMLS CUI [1])
Out-patients, age
Item
1. out-patients, 18 year and older.
boolean
C0029921 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
major depressive disorder with a recurrent major depressive episode according to dsmiv-tr criteria
Item
2. major depressive disorder (mdd) with a recurrentmajor depressive episode (mde) according to dsmiv-tr criteria
boolean
C0154409 (UMLS CUI [1,1])
C0220952 (UMLS CUI [1,2])
Duration of current depressive episode
Item
3. duration of current episode is at least of 6 weeksunless severity of symptoms justifies shorter duration.
boolean
C0154409 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Treatment or hospitalization or antidepressant treatment for a previous depressive episode
Item
4. patients have been treated or hospitalized for aprevious episode, or a previous episode requiredantidepressant treatment(s) at the recommended doselevel for a continuous total duration of at least 2months.
boolean
C0087111 (UMLS CUI [1,1])
C0154409 (UMLS CUI [1,2])
C0003289 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Exclusion criteria
Item
main exclusion criteria:
boolean
C0680251 (UMLS CUI [1])
Suicidal
Item
1. patients at immediate risk for suicidal behavior
boolean
C0438696 (UMLS CUI [1])
Major depressive episode with psychotic features, catatonic features, seasonal pattern or postpartum onset
Item
2. patients with a mde with psychotic features, catatonic features, seasonal pattern or postpartum onset
boolean
C0154413 (UMLS CUI [1])
C0520672 (UMLS CUI [2])
C0085159 (UMLS CUI [3])
C0221074 (UMLS CUI [4])
Duration of current depressive episode
Item
3. the duration of the current depressive episode is greater than 2 years
boolean
C0154409 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Current depressive episode secondary to a general medical condition
Item
4. patients whose current depressive episode is secondary to a general medical condition
boolean
C0520619 (UMLS CUI [1])
Bipolar disorder, psychotic disorder, or antisocial personality disorder
Item
5. patients with a lifetime history of (1) bipolar disorder, (2) psychotic disorder, (3) antisocial personality disorder
boolean
C0005586 (UMLS CUI [1])
C0033975 (UMLS CUI [2])
C0003431 (UMLS CUI [3])
Somatic treatments
Item
6. patients who have received non-pharmacologic, somatic treatments for psychiatric disease
boolean
C0037646 (UMLS CUI [1])
Psychotherapy
Item
7. patients who have initiated, stopped, or changed the frequency or nature of psychotherapy within 3 months prior to screening
boolean
C0033968 (UMLS CUI [1])

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