Informações:
Falhas:
ID
16908
Descrição
Efficacy and Safety of SR58611A in Patients With Major Depressive Disorder; ODM derived from: https://clinicaltrials.gov/show/NCT00252356
Link
https://clinicaltrials.gov/show/NCT00252356
Palavras-chave
Versões (1)
- 13/08/2016 13/08/2016 -
Transferido a
13 de agosto de 2016
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Major Depressive Disorder NCT00252356
Eligibility Major Depressive Disorder NCT00252356
- StudyEvent: Eligibility
Similar models
Eligibility Major Depressive Disorder NCT00252356
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
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])
C0001779 (UMLS CUI [2])
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])
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])
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])
C0154409 (UMLS CUI [1,2])
C0003289 (UMLS CUI [2])
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])
C0520672 (UMLS CUI [2])
C0085159 (UMLS CUI [3])
C0221074 (UMLS CUI [4])
Duration of the 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])
C0449238 (UMLS CUI [1,2])
Depressive episode secondary to 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])
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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