ID

30476

Description

Escitalopram and Sleep Architecture in Patients With Major Depressive Disorder; ODM derived from: https://clinicaltrials.gov/show/NCT00442481

Link

https://clinicaltrials.gov/show/NCT00442481

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 NCT00442481

English

Eligibility Major Depressive Disorder NCT00442481

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients suffering from mdd, excluding a depressive episode of bipolar disorder.
Description

Major Depressive Disorder | Exclusion Depressive episode Bipolar Disorder

Data type

boolean

Alias
UMLS CUI [1]
C1269683
UMLS CUI [2,1]
C2828389
UMLS CUI [2,2]
C0349217
UMLS CUI [2,3]
C0005586
the depressive episode is not secondary to a general medical condition or substance abuse.
Description

Exclusion Criteria | Depressive episode Secondary to Medical condition General | Depressive episode Secondary to Substance Use Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2,1]
C0349217
UMLS CUI [2,2]
C0175668
UMLS CUI [2,3]
C3843040
UMLS CUI [2,4]
C0205246
UMLS CUI [3,1]
C0349217
UMLS CUI [3,2]
C0175668
UMLS CUI [3,3]
C0038586
ages between 18-65 years old.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
patients receiving other medications must be on a stable dosage for one month before entering the trial, including hypnotics.
Description

Pharmaceutical Preparations Dosage Stable | Hypnotics Dosage Stable

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [2,1]
C0020591
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205360
able to understand and sign an informed consent form.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients suffering from sleep disturbances due to a physical condition (copd, sleep apnea or essential insomnia preceding the diagnosis of depression).
Description

Sleep disturbances Due to Physical Condition | Chronic Obstructive Airway Disease | Sleep Apnea | Sleeplessness Essential

Data type

boolean

Alias
UMLS CUI [1,1]
C0037317
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C3714565
UMLS CUI [2]
C0024117
UMLS CUI [3]
C0037315
UMLS CUI [4,1]
C0917801
UMLS CUI [4,2]
C0205224
patients suffering from an unstable clinically significant medical condition (cardiovascular, endocrine, nutritional, hepatic, urinary).
Description

Medical condition Unstable | Cardiovascular Diseases | Endocrine System Diseases | Nutrition Disorders | Liver diseases | Urinary system Diseases

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0443343
UMLS CUI [2]
C0007222
UMLS CUI [3]
C0014130
UMLS CUI [4]
C3714509
UMLS CUI [5]
C0023895
UMLS CUI [6]
C0042075
patients suffering from a malignancy or neuro-degenerative such as parkinsons’
Description

Malignant Neoplasms | Neurodegenerative Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0524851
disease
Description

Parkinson Disease

Data type

boolean

Alias
UMLS CUI [1]
C0030567
patients suffering from a clinically significant psychiatric psychotic disease, as judged by dsm-iv criteria, such as schizophrenia or acute psychosis.
Description

Mental disorders Psychotic | Schizophrenia | Psychotic Disorders

Data type

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0459435
UMLS CUI [2]
C0036341
UMLS CUI [3]
C0033975
patients experiencing severe withdrawal symptoms following a discontinuation of hypnotic drugs, upon entry into the baseline phase.
Description

Withdrawal Symptoms Severe | Status post Hypnotics Discontinuation

Data type

boolean

Alias
UMLS CUI [1,1]
C0087169
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C0020591
UMLS CUI [2,3]
C1444662
history of drug or alcohol dependence within the last year.
Description

Substance Dependence

Data type

boolean

Alias
UMLS CUI [1]
C0038580
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Similar models

Eligibility Major Depressive Disorder NCT00442481

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Major Depressive Disorder | Exclusion Depressive episode Bipolar Disorder
Item
patients suffering from mdd, excluding a depressive episode of bipolar disorder.
boolean
C1269683 (UMLS CUI [1])
C2828389 (UMLS CUI [2,1])
C0349217 (UMLS CUI [2,2])
C0005586 (UMLS CUI [2,3])
Exclusion Criteria | Depressive episode Secondary to Medical condition General | Depressive episode Secondary to Substance Use Disorders
Item
the depressive episode is not secondary to a general medical condition or substance abuse.
boolean
C0680251 (UMLS CUI [1])
C0349217 (UMLS CUI [2,1])
C0175668 (UMLS CUI [2,2])
C3843040 (UMLS CUI [2,3])
C0205246 (UMLS CUI [2,4])
C0349217 (UMLS CUI [3,1])
C0175668 (UMLS CUI [3,2])
C0038586 (UMLS CUI [3,3])
Age
Item
ages between 18-65 years old.
boolean
C0001779 (UMLS CUI [1])
Pharmaceutical Preparations Dosage Stable | Hypnotics Dosage Stable
Item
patients receiving other medications must be on a stable dosage for one month before entering the trial, including hypnotics.
boolean
C0013227 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0020591 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
Informed Consent
Item
able to understand and sign an informed consent form.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Sleep disturbances Due to Physical Condition | Chronic Obstructive Airway Disease | Sleep Apnea | Sleeplessness Essential
Item
patients suffering from sleep disturbances due to a physical condition (copd, sleep apnea or essential insomnia preceding the diagnosis of depression).
boolean
C0037317 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C3714565 (UMLS CUI [1,3])
C0024117 (UMLS CUI [2])
C0037315 (UMLS CUI [3])
C0917801 (UMLS CUI [4,1])
C0205224 (UMLS CUI [4,2])
Medical condition Unstable | Cardiovascular Diseases | Endocrine System Diseases | Nutrition Disorders | Liver diseases | Urinary system Diseases
Item
patients suffering from an unstable clinically significant medical condition (cardiovascular, endocrine, nutritional, hepatic, urinary).
boolean
C3843040 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0007222 (UMLS CUI [2])
C0014130 (UMLS CUI [3])
C3714509 (UMLS CUI [4])
C0023895 (UMLS CUI [5])
C0042075 (UMLS CUI [6])
Malignant Neoplasms | Neurodegenerative Disorders
Item
patients suffering from a malignancy or neuro-degenerative such as parkinsons’
boolean
C0006826 (UMLS CUI [1])
C0524851 (UMLS CUI [2])
Parkinson Disease
Item
disease
boolean
C0030567 (UMLS CUI [1])
Mental disorders Psychotic | Schizophrenia | Psychotic Disorders
Item
patients suffering from a clinically significant psychiatric psychotic disease, as judged by dsm-iv criteria, such as schizophrenia or acute psychosis.
boolean
C0004936 (UMLS CUI [1,1])
C0459435 (UMLS CUI [1,2])
C0036341 (UMLS CUI [2])
C0033975 (UMLS CUI [3])
Withdrawal Symptoms Severe | Status post Hypnotics Discontinuation
Item
patients experiencing severe withdrawal symptoms following a discontinuation of hypnotic drugs, upon entry into the baseline phase.
boolean
C0087169 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0231290 (UMLS CUI [2,1])
C0020591 (UMLS CUI [2,2])
C1444662 (UMLS CUI [2,3])
Substance Dependence
Item
history of drug or alcohol dependence within the last year.
boolean
C0038580 (UMLS CUI [1])
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