ID

13867

Description

Iloperidone Augmentation of SSRIs for Patients With Major Depressive Disorder With Residual Anger and Irritability; ODM derived from: https://clinicaltrials.gov/show/NCT01464229

Lien

https://clinicaltrials.gov/show/NCT01464229

Mots-clés

  1. 13/03/2016 13/03/2016 -
Téléchargé le

13 mars 2016

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0

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Eligibility Major Depressive Disorder NCT01464229

Eligibility Major Depressive Disorder NCT01464229

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
written informed consent.
Description

informed consent

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
men or women ages 18-65 years old.
Description

gender; age

Type de données

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
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.
Description

major depressive episode; Major depression in partial remission

Type de données

boolean

Alias
UMLS CUI [1]
C0024517
UMLS CUI [2]
C0270462
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).
Description

selective serotonin reuptake inhibitor; paroxetine; fluoxetine

Type de données

boolean

Alias
UMLS CUI [1]
C0360105
UMLS CUI [2]
C0070122
UMLS CUI [3]
C0016365
score > 8 on the anger/hostility scale of the symptom questionnaire both at screen and baseline.
Description

symptom questionnaire

Type de données

boolean

Alias
UMLS CUI [1]
C3641335
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
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.
Description

comorbidity DSM-IV criteria for major depressive diagnosis documented

Type de données

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C2199206
current, serious suicidal or homicidal risk.
Description

suicidal risk; homicidal

Type de données

boolean

Alias
UMLS CUI [1]
C0438696
UMLS CUI [2]
C0455204
pregnancy or breast-feeding.
Description

pregnancy; lactating

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
serious, unstable medical illness including cardiovascular, kidney, liver, neurological and endocrine disorders.
Description

comorbidity cardiovascular disease endocrine disorders

Type de données

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0007222
UMLS CUI [1,3]
C0014130
congenital long qt syndrome or a qtc > 450 ms.
Description

long qt syndrome

Type de données

boolean

Alias
UMLS CUI [1]
C0023976
history of cardiac arrhythmias.
Description

cardiac arrhythmias

Type de données

boolean

Alias
UMLS CUI [1]
C0003811
electroconvulsive therapy (ect) within the 6 months preceding baseline.
Description

electroconvulsive therapy

Type de données

boolean

Alias
UMLS CUI [1]
C0013806
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).
Description

concomitant therapy; Antipsychotic Agents

Type de données

boolean

Alias
UMLS CUI [1]
C1707479
UMLS CUI [2]
C0040615

Similar models

Eligibility Major Depressive Disorder NCT01464229

Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
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])
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])
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])
symptom questionnaire
Item
score > 8 on the anger/hostility scale of the symptom questionnaire both at screen and baseline.
boolean
C3641335 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
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])
suicidal risk; homicidal
Item
current, serious suicidal or homicidal risk.
boolean
C0438696 (UMLS CUI [1])
C0455204 (UMLS CUI [2])
pregnancy; lactating
Item
pregnancy or breast-feeding.
boolean
C0032961 (UMLS CUI [1])
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])
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])

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