ID

16907

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT00252330

Nyckelord

  1. 2016-08-13 2016-08-13 -
Uppladdad den

13 augusti 2016

DOI

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Licens

Creative Commons BY 4.0

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Eligibility Major Depressive Disorder NCT00252330

Eligibility Major Depressive Disorder NCT00252330

Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
main inclusion criteria:
Beskrivning

Inclusion criteria

Datatyp

boolean

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

Out-patients, age

Datatyp

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
Beskrivning

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

Datatyp

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.
Beskrivning

Duration of current depressive episode

Datatyp

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.
Beskrivning

Treatment or hospitalization or antidepressant treatment for a previous depressive episode

Datatyp

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
main exclusion criteria:
Beskrivning

Exclusion criteria

Datatyp

boolean

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

Suicidal

Datatyp

boolean

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

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

Datatyp

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
Beskrivning

Duration of current depressive episode

Datatyp

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
Beskrivning

Current depressive episode secondary to a general medical condition

Datatyp

boolean

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

Bipolar disorder, psychotic disorder, or antisocial personality disorder

Datatyp

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
Beskrivning

Somatic treatments

Datatyp

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
Beskrivning

Psychotherapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0033968

Similar models

Eligibility Major Depressive Disorder NCT00252330

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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