ID

18057

Beschreibung

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

Stichworte

Versionen (1)
  1. 17.10.16 17.10.16 -
Hochgeladen am

17. Oktober 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Major Depressive Disorder NCT00149825

Englisch

Eligibility Major Depressive Disorder NCT00149825

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of major depressive disorder
Beschreibung

Major Depressive Disorder

Datentyp

boolean

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

Hamilton rating scale for depression

Datentyp

boolean

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

Sleeplessness | Subjective insomnia complaint

Datentyp

boolean

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

Able to speak fluently English Language

Datentyp

boolean

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

Contraceptive methods

Datentyp

boolean

Alias
UMLS CUI [1]
C0700589
Exclusion Criteria
Beschreibung

Exclusion Criteria

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

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

Datentyp

boolean

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

Psychotic symptom

Datentyp

boolean

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

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

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

Substance Use Disorders

Datentyp

boolean

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

Psychiatric therapeutic procedure To be stopped Unwilling

Datentyp

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
Beschreibung

Electroconvulsive Therapy | Vagus Nerve Stimulation

Datentyp

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)
Beschreibung

Sleep Apnea Syndromes | Restless Legs Syndrome | Nocturnal Myoclonus Syndrome

Datentyp

boolean

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

Sleep Disorders

Datentyp

boolean

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

Pregnancy | Breast Feeding

Datentyp

boolean

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

Epilepsy

Datentyp

boolean

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

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

Datentyp

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
Beschreibung

Liver Dysfunction | Renal dysfunction

Datentyp

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)
Beschreibung

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

Datentyp

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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Ähnliche Modelle

Eligibility Major Depressive Disorder NCT00149825

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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