ID

30481

Description

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

Link

https://clinicaltrials.gov/show/NCT00628914

Keywords

Versions (1)
  1. 6/7/18 6/7/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 7, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Major Depressive Disorder NCT00628914

English

Eligibility Major Depressive Disorder NCT00628914

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

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

Outpatients | Major Depressive Disorder Unipolar

Data type

boolean

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

Hamilton Depression Rating Scale 17 Item Clinical Classification

Data type

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.
Description

Sleeplessness Hamilton Depression Rating Scale 17 Item Clinical Classification

Data type

boolean

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

Age

Data type

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.
Description

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

Data type

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
Description

Exclusion Criteria

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

Capability Mental Lacking | Capability Legal Lacking | Informed Consent Unable

Data type

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).
Description

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

Data type

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.
Description

Uncertainty Diagnostic | Ambiguity Diagnostic | Pseudodementia Rule out Depressive disorder

Data type

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.
Description

Anorexia Nervosa | Bulimia Nervosa | Obsessive-Compulsive Disorder

Data type

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.
Description

Substance Use Disorders

Data type

boolean

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

Sleeplessness Unresponsive to Treatment | Hypnotic or sedative drug

Data type

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.
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C0036572
UMLS CUI [2]
C0195775
UMLS CUI [3]
C0037304
UMLS CUI [4]
C0018674
UMLS CUI [5]
C0151611
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Similar models

Eligibility Major Depressive Disorder NCT00628914

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
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