ID

30481

Descripción

Brain Mechanisms and Targeting Insomnia in Major Depression; ODM derived from: https://clinicaltrials.gov/show/NCT00628914

Link

https://clinicaltrials.gov/show/NCT00628914

Palabras clave

Versiones (1)
  1. 7/6/18 7/6/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

7 de junio de 2018

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 Major Depressive Disorder NCT00628914

Inglés

Eligibility Major Depressive Disorder NCT00628914

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
outpatients with non-psychotic, unipolar major depressive disorder (mdd).
Descripción

Outpatients | Major Depressive Disorder Unipolar

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0029921
UMLS CUI [2,1]
C1269683
UMLS CUI [2,2]
C0443340
a score of >14 on the ham-d17.
Descripción

Hamilton Depression Rating Scale 17 Item Clinical Classification

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3639712
presence of insomnia, manifest by a total score of ≥ 4 combining all three sleep disturbance items on the ham-d17 scale.
Descripción

Sleeplessness Hamilton Depression Rating Scale 17 Item Clinical Classification

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0917801
UMLS CUI [1,2]
C3639712
age range: 18-64.
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
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.
Descripción

Feeling suicidal | Absence Self-harm Plan | Absence Self-harm Intent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0424000
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C0424366
UMLS CUI [2,3]
C1301732
UMLS CUI [3,1]
C0332197
UMLS CUI [3,2]
C0424366
UMLS CUI [3,3]
C1283828
Exclusion Criteria
Descripción

Exclusion Criteria

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

Capability Mental Lacking | Capability Legal Lacking | Informed Consent Unable

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2698977
UMLS CUI [1,2]
C0229992
UMLS CUI [1,3]
C0332268
UMLS CUI [2,1]
C2698977
UMLS CUI [2,2]
C1301860
UMLS CUI [2,3]
C0332268
UMLS CUI [3,1]
C0021430
UMLS CUI [3,2]
C1299582
patients who have a lifetime history of bipolar disorder, schizophrenia, schizoaffective disorder, mdd with psychotic features, or dementia (any etiology).
Descripción

Bipolar Disorder Lifetime | Schizophrenia Lifetime | Schizoaffective Disorder Lifetime | DEPRESSIVE DISORDER MAJOR WITH PSYCHOTIC FEATURE Lifetime | Dementia Lifetime

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0005586
UMLS CUI [1,2]
C4071830
UMLS CUI [2,1]
C0036341
UMLS CUI [2,2]
C4071830
UMLS CUI [3,1]
C0036337
UMLS CUI [3,2]
C4071830
UMLS CUI [4,1]
C0743080
UMLS CUI [4,2]
C4071830
UMLS CUI [5,1]
C0497327
UMLS CUI [5,2]
C4071830
patients with diagnostic uncertainty or ambiguity (e.g. rule-out pseudodementia of depression) will be excluded.
Descripción

Uncertainty Diagnostic | Ambiguity Diagnostic | Pseudodementia Rule out Depressive disorder

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0087130
UMLS CUI [1,2]
C0348026
UMLS CUI [2,1]
C2346729
UMLS CUI [2,2]
C0348026
UMLS CUI [3,1]
C0033797
UMLS CUI [3,2]
C0332196
UMLS CUI [3,3]
C0011581
patients with a current diagnosis of anorexia nervosa, bulimia nervosa, or obsessive compulsive disorder.
Descripción

Anorexia Nervosa | Bulimia Nervosa | Obsessive-Compulsive Disorder

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0003125
UMLS CUI [2]
C2267227
UMLS CUI [3]
C0028768
patients who have met diagnostic criteria for any current substance abuse disorder at any time in the 6 months prior to enrollment.
Descripción

Substance Use Disorders

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0038586
insomnia symptoms that have not responded to a previous trial of a sedativehypnotic prescription medication.
Descripción

Sleeplessness Unresponsive to Treatment | Hypnotic or sedative drug

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0917801
UMLS CUI [1,2]
C0205269
UMLS CUI [2]
C0301401
any history of seizures, brain surgery, skull fracture, significant head trauma, or previous abnormal eeg.
Descripción

Seizures | Operation on brain | Skull Fracture | Craniocerebral Trauma | EEG abnormal

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0036572
UMLS CUI [2]
C0195775
UMLS CUI [3]
C0037304
UMLS CUI [4]
C0018674
UMLS CUI [5]
C0151611
Volver a la parte superior de la página

Similar models

Eligibility Major Depressive Disorder NCT00628914

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Outpatients | Major Depressive Disorder Unipolar
Item
outpatients with non-psychotic, unipolar major depressive disorder (mdd).
boolean
C0029921 (UMLS CUI [1])
C1269683 (UMLS CUI [2,1])
C0443340 (UMLS CUI [2,2])
Hamilton Depression Rating Scale 17 Item Clinical Classification
Item
a score of >14 on the ham-d17.
boolean
C3639712 (UMLS CUI [1])
Sleeplessness Hamilton Depression Rating Scale 17 Item Clinical Classification
Item
presence of insomnia, manifest by a total score of ≥ 4 combining all three sleep disturbance items on the ham-d17 scale.
boolean
C0917801 (UMLS CUI [1,1])
C3639712 (UMLS CUI [1,2])
Age
Item
age range: 18-64.
boolean
C0001779 (UMLS CUI [1])
Feeling suicidal | Absence Self-harm Plan | Absence Self-harm Intent
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.
boolean
C0424000 (UMLS CUI [1])
C0332197 (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])
Item Group
C0680251 (UMLS CUI)
Capability Mental Lacking | Capability Legal Lacking | Informed Consent Unable
Item
patient is mentally or legally incapacitated, unable to give informed consent.
boolean
C2698977 (UMLS CUI [1,1])
C0229992 (UMLS CUI [1,2])
C0332268 (UMLS CUI [1,3])
C2698977 (UMLS CUI [2,1])
C1301860 (UMLS CUI [2,2])
C0332268 (UMLS CUI [2,3])
C0021430 (UMLS CUI [3,1])
C1299582 (UMLS CUI [3,2])
Bipolar Disorder Lifetime | Schizophrenia Lifetime | Schizoaffective Disorder Lifetime | DEPRESSIVE DISORDER MAJOR WITH PSYCHOTIC FEATURE Lifetime | Dementia Lifetime
Item
patients who have a lifetime history of bipolar disorder, schizophrenia, schizoaffective disorder, mdd with psychotic features, or dementia (any etiology).
boolean
C0005586 (UMLS CUI [1,1])
C4071830 (UMLS CUI [1,2])
C0036341 (UMLS CUI [2,1])
C4071830 (UMLS CUI [2,2])
C0036337 (UMLS CUI [3,1])
C4071830 (UMLS CUI [3,2])
C0743080 (UMLS CUI [4,1])
C4071830 (UMLS CUI [4,2])
C0497327 (UMLS CUI [5,1])
C4071830 (UMLS CUI [5,2])
Uncertainty Diagnostic | Ambiguity Diagnostic | Pseudodementia Rule out Depressive disorder
Item
patients with diagnostic uncertainty or ambiguity (e.g. rule-out pseudodementia of depression) will be excluded.
boolean
C0087130 (UMLS CUI [1,1])
C0348026 (UMLS CUI [1,2])
C2346729 (UMLS CUI [2,1])
C0348026 (UMLS CUI [2,2])
C0033797 (UMLS CUI [3,1])
C0332196 (UMLS CUI [3,2])
C0011581 (UMLS CUI [3,3])
Anorexia Nervosa | Bulimia Nervosa | Obsessive-Compulsive Disorder
Item
patients with a current diagnosis of anorexia nervosa, bulimia nervosa, or obsessive compulsive disorder.
boolean
C0003125 (UMLS CUI [1])
C2267227 (UMLS CUI [2])
C0028768 (UMLS CUI [3])
Substance Use Disorders
Item
patients who have met diagnostic criteria for any current substance abuse disorder at any time in the 6 months prior to enrollment.
boolean
C0038586 (UMLS CUI [1])
Sleeplessness Unresponsive to Treatment | Hypnotic or sedative drug
Item
insomnia symptoms that have not responded to a previous trial of a sedativehypnotic prescription medication.
boolean
C0917801 (UMLS CUI [1,1])
C0205269 (UMLS CUI [1,2])
C0301401 (UMLS CUI [2])
Seizures | Operation on brain | Skull Fracture | Craniocerebral Trauma | EEG abnormal
Item
any history of seizures, brain surgery, skull fracture, significant head trauma, or previous abnormal eeg.
boolean
C0036572 (UMLS CUI [1])
C0195775 (UMLS CUI [2])
C0037304 (UMLS CUI [3])
C0018674 (UMLS CUI [4])
C0151611 (UMLS CUI [5])
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