Informações:
Falhas:
ID
13867
Descrição
Iloperidone Augmentation of SSRIs for Patients With Major Depressive Disorder With Residual Anger and Irritability; ODM derived from: https://clinicaltrials.gov/show/NCT01464229
Link
https://clinicaltrials.gov/show/NCT01464229
Palavras-chave
Versões (1)
- 13/03/2016 13/03/2016 -
Transferido a
13 de março de 2016
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Major Depressive Disorder NCT01464229
Eligibility Major Depressive Disorder NCT01464229
- StudyEvent: Eligibility
Similar models
Eligibility Major Depressive Disorder NCT01464229
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
informed consent
Item
written informed consent.
boolean
C0021430 (UMLS CUI [1])
gender; age
Item
men or women ages 18-65 years old.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0001779 (UMLS CUI [2])
major depressive episode; Major depression in partial remission
Item
current major depressive episode in partial remission based on the structured clinical interview for dsm iv-axis i disorders (scid i/p) and a ham-d-17 score between 9 and 15.
boolean
C0024517 (UMLS CUI [1])
C0270462 (UMLS CUI [2])
C0270462 (UMLS CUI [2])
selective serotonin reuptake inhibitor; paroxetine; fluoxetine
Item
current treatment with a selective serotonin reuptake inhibitor (ssri) other than paroxetine or fluoxetine for at least three months, at a stable dose for the past 4 weeks, and more than 50% but less than 75% improvement on the current antidepressant, as determined by the mgh antidepressant treatment response questionnaire (atrq).
boolean
C0360105 (UMLS CUI [1])
C0070122 (UMLS CUI [2])
C0016365 (UMLS CUI [3])
C0070122 (UMLS CUI [2])
C0016365 (UMLS CUI [3])
symptom questionnaire
Item
score > 8 on the anger/hostility scale of the symptom questionnaire both at screen and baseline.
boolean
C3641335 (UMLS CUI [1])
comorbidity DSM-IV criteria for major depressive diagnosis documented
Item
the following dsm-iv diagnoses: 1) organic mental disorders; 2) substance use disorders, including alcohol, active within the last 3 months; 3) schizophrenia; 4) delusional disorder; 5) psychotic disorders not elsewhere classified; 6) bipolar disorder; and 9) antisocial personality disorder; 10) dementia.
boolean
C0009488 (UMLS CUI [1,1])
C2199206 (UMLS CUI [1,2])
C2199206 (UMLS CUI [1,2])
suicidal risk; homicidal
Item
current, serious suicidal or homicidal risk.
boolean
C0438696 (UMLS CUI [1])
C0455204 (UMLS CUI [2])
C0455204 (UMLS CUI [2])
pregnancy; lactating
Item
pregnancy or breast-feeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0006147 (UMLS CUI [2])
comorbidity cardiovascular disease endocrine disorders
Item
serious, unstable medical illness including cardiovascular, kidney, liver, neurological and endocrine disorders.
boolean
C0009488 (UMLS CUI [1,1])
C0007222 (UMLS CUI [1,2])
C0014130 (UMLS CUI [1,3])
C0007222 (UMLS CUI [1,2])
C0014130 (UMLS CUI [1,3])
long qt syndrome
Item
congenital long qt syndrome or a qtc > 450 ms.
boolean
C0023976 (UMLS CUI [1])
cardiac arrhythmias
Item
history of cardiac arrhythmias.
boolean
C0003811 (UMLS CUI [1])
electroconvulsive therapy
Item
electroconvulsive therapy (ect) within the 6 months preceding baseline.
boolean
C0013806 (UMLS CUI [1])
concomitant therapy; Antipsychotic Agents
Item
concomitant use of buspirone, fluoxetine, paroxetine, any psychostimulant, modafinil, other antipsychotic drugs, or anticonvulsants (although stable doses of benzodiazepines and hypnotics are allowed) (see concomitant therapy).
boolean
C1707479 (UMLS CUI [1])
C0040615 (UMLS CUI [2])
C0040615 (UMLS CUI [2])