ID

18057

Descripción

Combining Antidepressant Medication and Psychotherapy for Insomnia to Improve Depression Outcome; ODM derived from: https://clinicaltrials.gov/show/NCT00149825

Link

https://clinicaltrials.gov/show/NCT00149825

Palabras clave

Versiones (1)
  1. 17/10/16 17/10/16 -
Subido en

17 de octubre de 2016

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Major Depressive Disorder NCT00149825

Inglés

Eligibility Major Depressive Disorder NCT00149825

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of major depressive disorder
Descripción

Major Depressive Disorder

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1269683
hrsd(17) score of at least 14
Descripción

Hamilton rating scale for depression

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0451203
presence and complaint of insomnia for at least 1 month
Descripción

Sleeplessness | Subjective insomnia complaint

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0917801
UMLS CUI [2]
C0865378
fluent in english
Descripción

Able to speak fluently English Language

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0564241
UMLS CUI [1,2]
C0376245
use of an effective form of contraception throughout the study
Descripción

Contraceptive methods

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0700589
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
other psychiatric disorders (e.g., bipolar disorder, post traumatic stress disorder, obsessive compulsive disorder, eating disorder)
Descripción

Mental disorders | Bipolar Disorder | Post-Traumatic Stress Disorder | Obsessive-Compulsive Disorder | Eating Disorders

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0004936
UMLS CUI [2]
C0005586
UMLS CUI [3]
C0038436
UMLS CUI [4]
C0028768
UMLS CUI [5]
C0013473
psychotic symptoms
Descripción

Psychotic symptom

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0871189
serious, unstable, or terminal medical condition
Descripción

Medical condition Serious | Medical condition Unstable | Medical condition End-stage

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0443343
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C0205088
axis ii diagnosis of antisocial, schizotypal, or severe borderline personality disorder
Descripción

Axis II diagnosis | Antisocial Personality Disorder | Schizotypal Personality Disorder | Borderline Personality Disorder Severe

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0270288
UMLS CUI [2]
C0003431
UMLS CUI [3]
C0036363
UMLS CUI [4,1]
C0006012
UMLS CUI [4,2]
C0205082
substance abuse
Descripción

Substance Use Disorders

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0038586
not willing to end other psychiatric treatment
Descripción

Psychiatric therapeutic procedure To be stopped Unwilling

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0204523
UMLS CUI [1,2]
C1272691
UMLS CUI [1,3]
C0558080
previous electroconvulsive therapy or vagus nerve stimulation treatment during the last year
Descripción

Electroconvulsive Therapy | Vagus Nerve Stimulation

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0013806
UMLS CUI [2]
C2350432
sleep apnea, restless leg, or periodic limb movement disorder (to be ruled out after first sleep study)
Descripción

Sleep Apnea Syndromes | Restless Legs Syndrome | Nocturnal Myoclonus Syndrome

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0037315
UMLS CUI [2]
C0035258
UMLS CUI [3]
C0751774
other sleep disorders
Descripción

Sleep Disorders

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0851578
currently pregnant or breastfeeding
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
history of seizure disorder
Descripción

Epilepsy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0014544
disease or condition that produces altered metabolism or hemodynamic responses
Descripción

Disease Resulting in Metabolism altered | Disease Resulting in Response Hemodynamic | Condition Resulting in Metabolism altered | Condition Resulting in Response Hemodynamic

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0332294
UMLS CUI [1,3]
C0025519
UMLS CUI [1,4]
C0392747
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0332294
UMLS CUI [2,3]
C0871261
UMLS CUI [2,4]
C0019010
UMLS CUI [3,1]
C0348080
UMLS CUI [3,2]
C0332294
UMLS CUI [3,3]
C0025519
UMLS CUI [3,4]
C0392747
UMLS CUI [4,1]
C0348080
UMLS CUI [4,2]
C0332294
UMLS CUI [4,3]
C0871261
UMLS CUI [4,4]
C0019010
liver or kidney dysfunction
Descripción

Liver Dysfunction | Renal dysfunction

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2]
C3279454
current use of any over the counter medications or herbs for mood or sleep benefits (e.g., melatonin, valerian, kava, hop extract, st. john's wort, same)
Descripción

taking over-the-counter medication Mood benefit | Herbs--Therapeutic use Mood benefit | taking over-the-counter medication Sleep benefit | Herbs--Therapeutic use Sleep benefit | Melatonin | Valerian | Kava preparation | Hova | Hypericum perforatum

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2054160
UMLS CUI [1,2]
C0026516
UMLS CUI [1,3]
C0814225
UMLS CUI [2,1]
C3826216
UMLS CUI [2,2]
C0026516
UMLS CUI [2,3]
C0814225
UMLS CUI [3,1]
C2054160
UMLS CUI [3,2]
C0037313
UMLS CUI [3,3]
C0814225
UMLS CUI [4,1]
C3826216
UMLS CUI [4,2]
C0037313
UMLS CUI [4,3]
C0814225
UMLS CUI [5]
C0025219
UMLS CUI [6]
C0042281
UMLS CUI [7]
C0939882
UMLS CUI [8]
C0062977
UMLS CUI [9]
C0936242
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Similar models

Eligibility Major Depressive Disorder NCT00149825

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Major Depressive Disorder
Item
diagnosis of major depressive disorder
boolean
C1269683 (UMLS CUI [1])
Hamilton rating scale for depression
Item
hrsd(17) score of at least 14
boolean
C0451203 (UMLS CUI [1])
Sleeplessness | Subjective insomnia complaint
Item
presence and complaint of insomnia for at least 1 month
boolean
C0917801 (UMLS CUI [1])
C0865378 (UMLS CUI [2])
Able to speak fluently English Language
Item
fluent in english
boolean
C0564241 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
Contraceptive methods
Item
use of an effective form of contraception throughout the study
boolean
C0700589 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Mental disorders | Bipolar Disorder | Post-Traumatic Stress Disorder | Obsessive-Compulsive Disorder | Eating Disorders
Item
other psychiatric disorders (e.g., bipolar disorder, post traumatic stress disorder, obsessive compulsive disorder, eating disorder)
boolean
C0004936 (UMLS CUI [1])
C0005586 (UMLS CUI [2])
C0038436 (UMLS CUI [3])
C0028768 (UMLS CUI [4])
C0013473 (UMLS CUI [5])
Psychotic symptom
Item
psychotic symptoms
boolean
C0871189 (UMLS CUI [1])
Medical condition Serious | Medical condition Unstable | Medical condition End-stage
Item
serious, unstable, or terminal medical condition
boolean
C3843040 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C3843040 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
C3843040 (UMLS CUI [3,1])
C0205088 (UMLS CUI [3,2])
Axis II diagnosis | Antisocial Personality Disorder | Schizotypal Personality Disorder | Borderline Personality Disorder Severe
Item
axis ii diagnosis of antisocial, schizotypal, or severe borderline personality disorder
boolean
C0270288 (UMLS CUI [1])
C0003431 (UMLS CUI [2])
C0036363 (UMLS CUI [3])
C0006012 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
Substance Use Disorders
Item
substance abuse
boolean
C0038586 (UMLS CUI [1])
Psychiatric therapeutic procedure To be stopped Unwilling
Item
not willing to end other psychiatric treatment
boolean
C0204523 (UMLS CUI [1,1])
C1272691 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
Electroconvulsive Therapy | Vagus Nerve Stimulation
Item
previous electroconvulsive therapy or vagus nerve stimulation treatment during the last year
boolean
C0013806 (UMLS CUI [1])
C2350432 (UMLS CUI [2])
Sleep Apnea Syndromes | Restless Legs Syndrome | Nocturnal Myoclonus Syndrome
Item
sleep apnea, restless leg, or periodic limb movement disorder (to be ruled out after first sleep study)
boolean
C0037315 (UMLS CUI [1])
C0035258 (UMLS CUI [2])
C0751774 (UMLS CUI [3])
Sleep Disorders
Item
other sleep disorders
boolean
C0851578 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
currently pregnant or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Epilepsy
Item
history of seizure disorder
boolean
C0014544 (UMLS CUI [1])
Disease Resulting in Metabolism altered | Disease Resulting in Response Hemodynamic | Condition Resulting in Metabolism altered | Condition Resulting in Response Hemodynamic
Item
disease or condition that produces altered metabolism or hemodynamic responses
boolean
C0012634 (UMLS CUI [1,1])
C0332294 (UMLS CUI [1,2])
C0025519 (UMLS CUI [1,3])
C0392747 (UMLS CUI [1,4])
C0012634 (UMLS CUI [2,1])
C0332294 (UMLS CUI [2,2])
C0871261 (UMLS CUI [2,3])
C0019010 (UMLS CUI [2,4])
C0348080 (UMLS CUI [3,1])
C0332294 (UMLS CUI [3,2])
C0025519 (UMLS CUI [3,3])
C0392747 (UMLS CUI [3,4])
C0348080 (UMLS CUI [4,1])
C0332294 (UMLS CUI [4,2])
C0871261 (UMLS CUI [4,3])
C0019010 (UMLS CUI [4,4])
Liver Dysfunction | Renal dysfunction
Item
liver or kidney dysfunction
boolean
C0086565 (UMLS CUI [1])
C3279454 (UMLS CUI [2])
taking over-the-counter medication Mood benefit | Herbs--Therapeutic use Mood benefit | taking over-the-counter medication Sleep benefit | Herbs--Therapeutic use Sleep benefit | Melatonin | Valerian | Kava preparation | Hova | Hypericum perforatum
Item
current use of any over the counter medications or herbs for mood or sleep benefits (e.g., melatonin, valerian, kava, hop extract, st. john's wort, same)
boolean
C2054160 (UMLS CUI [1,1])
C0026516 (UMLS CUI [1,2])
C0814225 (UMLS CUI [1,3])
C3826216 (UMLS CUI [2,1])
C0026516 (UMLS CUI [2,2])
C0814225 (UMLS CUI [2,3])
C2054160 (UMLS CUI [3,1])
C0037313 (UMLS CUI [3,2])
C0814225 (UMLS CUI [3,3])
C3826216 (UMLS CUI [4,1])
C0037313 (UMLS CUI [4,2])
C0814225 (UMLS CUI [4,3])
C0025219 (UMLS CUI [5])
C0042281 (UMLS CUI [6])
C0939882 (UMLS CUI [7])
C0062977 (UMLS CUI [8])
C0936242 (UMLS CUI [9])
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