ID

35664

Descripción

Electrical Stimulation in Patients With Unipolar Major Depression; ODM derived from: https://clinicaltrials.gov/show/NCT02239809

Link

https://clinicaltrials.gov/show/NCT02239809

Palabras clave

Versiones (1)
  1. 14/3/19 14/3/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

14 de marzo de 2019

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY 4.0
Comentarios del modelo :

Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.

Volver a los comentarios del modelo
Comentarios de grupo de elementos para :

Comentarios del elemento para :

Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.

Eligibility Depression NCT02239809

Inglés

Eligibility Depression NCT02239809

1 formularios  
  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT02239809
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
outpatients with non-psychotic, unipolar major depressive disorder assessed via the mini structured interview and legally capacitated to sign the informed consent for participation in the study;
Descripción

DEPRESSIVE DISORDER MAJOR WITHOUT PSYCHOTIC FEATURE Unipolar | Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0743081
UMLS CUI [1,2]
C0443340
UMLS CUI [2]
C0021430
a score of ≥ 14 on the ham-d17 with item 1 (depressed mood) ≥ 2;
Descripción

Hamilton Depression Rating Scale 17 Item Clinical Classification | Depressed mood

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3639712
UMLS CUI [2]
C0344315
a history of treatment failure with at least 3 adequate trials antidepressants over the previous 6 weeks and less than 6 medications, with no change in antidepressant medication or dose within the previous 6 weeks, and ongoing use of at least one antidepressant (which will continue during participation in the study);
Descripción

Treatment failure | Antidepressive Agents Quantity | Pharmaceutical Preparations Quantity | Antidepressive Agents Unchanged | Dosage Unchanged

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0162643
UMLS CUI [2,1]
C0003289
UMLS CUI [2,2]
C1265611
UMLS CUI [3,1]
C0013227
UMLS CUI [3,2]
C1265611
UMLS CUI [4,1]
C0003289
UMLS CUI [4,2]
C0442739
UMLS CUI [5,1]
C0178602
UMLS CUI [5,2]
C0442739
patients with suicidal ideation are eligible only if the thoughts of death or of life not being worth living are not accompanied by a plan or intention for self-harm and lack of self-harming attempt in the past 6 months;
Descripción

Feeling suicidal | Self-harm Plan Absent | Self-harm Intention Absent | Self-harm Attempt Lacking

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0424000
UMLS CUI [2,1]
C0424366
UMLS CUI [2,2]
C1301732
UMLS CUI [2,3]
C0332197
UMLS CUI [3,1]
C0424366
UMLS CUI [3,2]
C1283828
UMLS CUI [3,3]
C0332197
UMLS CUI [4,1]
C0424366
UMLS CUI [4,2]
C1516084
UMLS CUI [4,3]
C0332268
patients with appropriate support to be compliant with the study protocol.
Descripción

Protocol Compliance

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0525058
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient is mentally or legally incapacitated, unable to give informed consent.
Descripción

Mental impairment | Legal capacity Lacking | Informed Consent Unable

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0683322
UMLS CUI [2,1]
C0683673
UMLS CUI [2,2]
C0332268
UMLS CUI [3,1]
C0021430
UMLS CUI [3,2]
C1299582
patients with psychosis (psychotic depression, schizophrenia, or schizoaffective diagnoses (lifetime); bipolar disorder (lifetime); dementia (lifetime); delirium or any substance abuse disorder within the past 6 months; eating disorder within the past year; obsessive-compulsive disorder (lifetime); post-traumatic stress disorder within the past year; acute risk for suicide or self-injurious behavior. patients with diagnostic uncertainty or ambiguity (e.g. rule-out pseudo-dementia of depression) will be excluded.
Descripción

Psychotic Disorders | Depression, psychotic | Schizophrenia | Schizoaffective Disorder Lifetime | Bipolar Disorder Lifetime | Dementia Lifetime | Delirium | Substance Use Disorders | Eating Disorders | Obsessive-Compulsive Disorder Lifetime | Post-Traumatic Stress Disorder | At risk for suicide | At risk of self-injurious behavior | Uncertainty Diagnostic | Ambiguity Diagnostic

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0033975
UMLS CUI [2]
C0743072
UMLS CUI [3]
C0036341
UMLS CUI [4,1]
C0036337
UMLS CUI [4,2]
C4071830
UMLS CUI [5,1]
C0005586
UMLS CUI [5,2]
C4071830
UMLS CUI [6,1]
C0497327
UMLS CUI [6,2]
C4071830
UMLS CUI [7]
C0011206
UMLS CUI [8]
C0038586
UMLS CUI [9]
C0013473
UMLS CUI [10,1]
C0028768
UMLS CUI [10,2]
C4071830
UMLS CUI [11]
C0038436
UMLS CUI [12]
C0563664
UMLS CUI [13]
C3875124
UMLS CUI [14,1]
C0087130
UMLS CUI [14,2]
C0348026
UMLS CUI [15,1]
C2346729
UMLS CUI [15,2]
C0348026
patients currently receiving more than six medications for treatment of mdd;
Descripción

Pharmaceutical Preparations Quantity Major Depressive Disorder

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C1269683
patients with exposure to ect or rtms or any investigational treatment (for any disorder) within the past 6 months;
Descripción

Exposure to Electroconvulsive Therapy | Exposure to Repetitive Transcranial Magnetic Stimulation | Exposure to Investigational Therapy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C0013806
UMLS CUI [2,1]
C0332157
UMLS CUI [2,2]
C0872259
UMLS CUI [3,1]
C0332157
UMLS CUI [3,2]
C0949266
prior vns and/or dbs therapy (lifetime);
Descripción

Vagus Nerve Stimulation Lifetime | Deep Brain Stimulation Lifetime

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2350432
UMLS CUI [1,2]
C4071830
UMLS CUI [2,1]
C0394162
UMLS CUI [2,2]
C4071830
past history of skull fracture; cranial surgery entering the calvarium; space occupying intracranial lesion; stroke, cva, or tias; cerebral aneurysm; parkinson's or huntington's disease; or multiple sclerosis;
Descripción

Skull Fracture | Cranial surgery Calvarium | Intracranial space-occupying lesion | Cerebrovascular accident | Transient Ischemic Attack | Cerebral Aneurysm | Parkinson Disease | Huntington Disease | Multiple Sclerosis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0037304
UMLS CUI [2,1]
C2224798
UMLS CUI [2,2]
C0205950
UMLS CUI [3]
C0495785
UMLS CUI [4]
C0038454
UMLS CUI [5]
C0007787
UMLS CUI [6]
C0917996
UMLS CUI [7]
C0030567
UMLS CUI [8]
C0020179
UMLS CUI [9]
C0026769
current pregnancy, breast feeding, plans to become pregnant during the study, or not using a medically accepted means of contraception;
Descripción

Pregnancy | Breast Feeding | Pregnancy, Planned | Contraceptive methods Absent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
UMLS CUI [4,1]
C0700589
UMLS CUI [4,2]
C0332197
other medical conditions that would increase the risk of infection or surgical related morbidity and/or would affect compliance with the study protocol.
Descripción

Other medical condition At risk Communicable Disease | Morbidity Surgical Related | Other medical condition Affecting Protocol Compliance

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C1444641
UMLS CUI [1,3]
C0009450
UMLS CUI [2,1]
C0220880
UMLS CUI [2,2]
C0543467
UMLS CUI [2,3]
C0439849
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C0392760
UMLS CUI [3,3]
C0525058
Volver a la parte superior de la página

Similar models

Eligibility Depression NCT02239809

1 formularios
  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT02239809
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
DEPRESSIVE DISORDER MAJOR WITHOUT PSYCHOTIC FEATURE Unipolar | Informed Consent
Item
outpatients with non-psychotic, unipolar major depressive disorder assessed via the mini structured interview and legally capacitated to sign the informed consent for participation in the study;
boolean
C0743081 (UMLS CUI [1,1])
C0443340 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2])
Hamilton Depression Rating Scale 17 Item Clinical Classification | Depressed mood
Item
a score of ≥ 14 on the ham-d17 with item 1 (depressed mood) ≥ 2;
boolean
C3639712 (UMLS CUI [1])
C0344315 (UMLS CUI [2])
Treatment failure | Antidepressive Agents Quantity | Pharmaceutical Preparations Quantity | Antidepressive Agents Unchanged | Dosage Unchanged
Item
a history of treatment failure with at least 3 adequate trials antidepressants over the previous 6 weeks and less than 6 medications, with no change in antidepressant medication or dose within the previous 6 weeks, and ongoing use of at least one antidepressant (which will continue during participation in the study);
boolean
C0162643 (UMLS CUI [1])
C0003289 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0013227 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0003289 (UMLS CUI [4,1])
C0442739 (UMLS CUI [4,2])
C0178602 (UMLS CUI [5,1])
C0442739 (UMLS CUI [5,2])
Feeling suicidal | Self-harm Plan Absent | Self-harm Intention Absent | Self-harm Attempt Lacking
Item
patients with suicidal ideation are eligible only if the thoughts of death or of life not being worth living are not accompanied by a plan or intention for self-harm and lack of self-harming attempt in the past 6 months;
boolean
C0424000 (UMLS CUI [1])
C0424366 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C0424366 (UMLS CUI [3,1])
C1283828 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
C0424366 (UMLS CUI [4,1])
C1516084 (UMLS CUI [4,2])
C0332268 (UMLS CUI [4,3])
Protocol Compliance
Item
patients with appropriate support to be compliant with the study protocol.
boolean
C0525058 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Mental impairment | Legal capacity Lacking | Informed Consent Unable
Item
patient is mentally or legally incapacitated, unable to give informed consent.
boolean
C0683322 (UMLS CUI [1])
C0683673 (UMLS CUI [2,1])
C0332268 (UMLS CUI [2,2])
C0021430 (UMLS CUI [3,1])
C1299582 (UMLS CUI [3,2])
Psychotic Disorders | Depression, psychotic | Schizophrenia | Schizoaffective Disorder Lifetime | Bipolar Disorder Lifetime | Dementia Lifetime | Delirium | Substance Use Disorders | Eating Disorders | Obsessive-Compulsive Disorder Lifetime | Post-Traumatic Stress Disorder | At risk for suicide | At risk of self-injurious behavior | Uncertainty Diagnostic | Ambiguity Diagnostic
Item
patients with psychosis (psychotic depression, schizophrenia, or schizoaffective diagnoses (lifetime); bipolar disorder (lifetime); dementia (lifetime); delirium or any substance abuse disorder within the past 6 months; eating disorder within the past year; obsessive-compulsive disorder (lifetime); post-traumatic stress disorder within the past year; acute risk for suicide or self-injurious behavior. patients with diagnostic uncertainty or ambiguity (e.g. rule-out pseudo-dementia of depression) will be excluded.
boolean
C0033975 (UMLS CUI [1])
C0743072 (UMLS CUI [2])
C0036341 (UMLS CUI [3])
C0036337 (UMLS CUI [4,1])
C4071830 (UMLS CUI [4,2])
C0005586 (UMLS CUI [5,1])
C4071830 (UMLS CUI [5,2])
C0497327 (UMLS CUI [6,1])
C4071830 (UMLS CUI [6,2])
C0011206 (UMLS CUI [7])
C0038586 (UMLS CUI [8])
C0013473 (UMLS CUI [9])
C0028768 (UMLS CUI [10,1])
C4071830 (UMLS CUI [10,2])
C0038436 (UMLS CUI [11])
C0563664 (UMLS CUI [12])
C3875124 (UMLS CUI [13])
C0087130 (UMLS CUI [14,1])
C0348026 (UMLS CUI [14,2])
C2346729 (UMLS CUI [15,1])
C0348026 (UMLS CUI [15,2])
Pharmaceutical Preparations Quantity Major Depressive Disorder
Item
patients currently receiving more than six medications for treatment of mdd;
boolean
C0013227 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1269683 (UMLS CUI [1,3])
Exposure to Electroconvulsive Therapy | Exposure to Repetitive Transcranial Magnetic Stimulation | Exposure to Investigational Therapy
Item
patients with exposure to ect or rtms or any investigational treatment (for any disorder) within the past 6 months;
boolean
C0332157 (UMLS CUI [1,1])
C0013806 (UMLS CUI [1,2])
C0332157 (UMLS CUI [2,1])
C0872259 (UMLS CUI [2,2])
C0332157 (UMLS CUI [3,1])
C0949266 (UMLS CUI [3,2])
Vagus Nerve Stimulation Lifetime | Deep Brain Stimulation Lifetime
Item
prior vns and/or dbs therapy (lifetime);
boolean
C2350432 (UMLS CUI [1,1])
C4071830 (UMLS CUI [1,2])
C0394162 (UMLS CUI [2,1])
C4071830 (UMLS CUI [2,2])
Skull Fracture | Cranial surgery Calvarium | Intracranial space-occupying lesion | Cerebrovascular accident | Transient Ischemic Attack | Cerebral Aneurysm | Parkinson Disease | Huntington Disease | Multiple Sclerosis
Item
past history of skull fracture; cranial surgery entering the calvarium; space occupying intracranial lesion; stroke, cva, or tias; cerebral aneurysm; parkinson's or huntington's disease; or multiple sclerosis;
boolean
C0037304 (UMLS CUI [1])
C2224798 (UMLS CUI [2,1])
C0205950 (UMLS CUI [2,2])
C0495785 (UMLS CUI [3])
C0038454 (UMLS CUI [4])
C0007787 (UMLS CUI [5])
C0917996 (UMLS CUI [6])
C0030567 (UMLS CUI [7])
C0020179 (UMLS CUI [8])
C0026769 (UMLS CUI [9])
Pregnancy | Breast Feeding | Pregnancy, Planned | Contraceptive methods Absent
Item
current pregnancy, breast feeding, plans to become pregnant during the study, or not using a medically accepted means of contraception;
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
C0700589 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Other medical condition At risk Communicable Disease | Morbidity Surgical Related | Other medical condition Affecting Protocol Compliance
Item
other medical conditions that would increase the risk of infection or surgical related morbidity and/or would affect compliance with the study protocol.
boolean
C3843040 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C0009450 (UMLS CUI [1,3])
C0220880 (UMLS CUI [2,1])
C0543467 (UMLS CUI [2,2])
C0439849 (UMLS CUI [2,3])
C3843040 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C0525058 (UMLS CUI [3,3])
Volver a la parte superior de la página 

Contacto

Utilice este formulario para comentarios, preguntas y sugerencias.

Los campos marcados con * son obligatorios.

Ayuda

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial