ID

35715

Description

A Study to Investigate the Effect of JNJ-42847922 on Polysomnography Measures in Patients With Major Depressive Disorder With Insomnia Who Are Stably Treated With Antidepressants; ODM derived from: https://clinicaltrials.gov/show/NCT02067299

Link

https://clinicaltrials.gov/show/NCT02067299

Keywords

Versions (2)
  1. 3/17/19 3/17/19 -
  2. 3/17/19 3/17/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

March 17, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Depressive Disorder, Major NCT02067299

English

Eligibility Depressive Disorder, Major NCT02067299

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
participants with a current/recurrent or past episode of major depressive disorder (mdd) as established per mini international neuropsychiatric interview at screening or otherwise specified by the treating physician
Description

Major Depressive Disorder | Major Depressive Disorder Recurrent | Major depressive episode In the past

Data type

boolean

Alias
UMLS CUI [1]
C1269683
UMLS CUI [2,1]
C1269683
UMLS CUI [2,2]
C2945760
UMLS CUI [3,1]
C0024517
UMLS CUI [3,2]
C1444637
stably treated with selective serotonin re-uptake inhibitor /
Description

Selective Serotonin Reuptake Inhibitors Stable

Data type

boolean

Alias
UMLS CUI [1,1]
C0360105
UMLS CUI [1,2]
C0205360
serotonin-norepinephrine reuptake inhibitor monotherapy, with no change in dose in the last 30 days before screening
Description

Serotonin and Norepinephrine Reuptake Inhibitors (SNRIs) Dose unchanged

Data type

boolean

Alias
UMLS CUI [1,1]
C1579361
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0442739
insomnia per polysomnography (a diagnostic test to measure and record physiologic variables like latency to persistent sleep, total sleep time, sleep efficiency, time spent awake, and total time spent in deep sleep, during sleep)
Description

Sleeplessness Polysomnography

Data type

boolean

Alias
UMLS CUI [1,1]
C0917801
UMLS CUI [1,2]
C0162701
participants must be healthy / medically stable on the basis of clinical laboratory tests performed at screening
Description

Healthy Volunteers Laboratory Procedures | Stable status Medical Laboratory Procedures

Data type

boolean

Alias
UMLS CUI [1,1]
C1708335
UMLS CUI [1,2]
C0022885
UMLS CUI [2,1]
C0205360
UMLS CUI [2,2]
C0205476
UMLS CUI [2,3]
C0022885
female participants should not be of child bearing potential due to either tubal ligation or hysterectomy or who are postmenopausal (no spontaneous menses for at least 2 years)
Description

Gender Childbearing Potential Absent | Tubal Ligation | Hysterectomy | Postmenopausal state | Menses Spontaneous Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C3831118
UMLS CUI [1,3]
C0332197
UMLS CUI [2]
C0520483
UMLS CUI [3]
C0020699
UMLS CUI [4]
C0232970
UMLS CUI [5,1]
C0025344
UMLS CUI [5,2]
C0205359
UMLS CUI [5,3]
C0332197
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
has a current diagnosis of a psychotic disorder, mdd with psychosis, bipolar disorder, mental retardation, or cluster b personality disorder (eg, borderline personality disorders, antisocial personality disorder)
Description

Psychotic Disorder | Major Depressive Disorder with Psychotic Disorder | Bipolar Disorder | Mental Retardation | Personality Disorders | Borderline Personality Disorder | Antisocial Personality Disorder

Data type

boolean

Alias
UMLS CUI [1]
C0033975
UMLS CUI [2,1]
C1269683
UMLS CUI [2,2]
C0332287
UMLS CUI [2,3]
C0033975
UMLS CUI [3]
C0005586
UMLS CUI [4]
C0025362
UMLS CUI [5]
C0031212
UMLS CUI [6]
C0006012
UMLS CUI [7]
C0003431
has been diagnosed with sleep-related breathing disorder
Description

Abnormal breathing Sleep Related

Data type

boolean

Alias
UMLS CUI [1,1]
C1260922
UMLS CUI [1,2]
C0037313
UMLS CUI [1,3]
C0439849
has suicidal ideation with some intent to act, or has homicidal ideation/intent, per principal investigator's clinical judgment
Description

Feeling suicidal | Suicidal intent | Homicidal thoughts | Homicidal intent

Data type

boolean

Alias
UMLS CUI [1]
C0424000
UMLS CUI [2]
C0582496
UMLS CUI [3]
C0455204
UMLS CUI [4]
C2046965
abnormal day/night rhythm, eg, nightshift worker, or normal bed time past midnight
Description

Abnormal circadian rhythm | Night shift worker | Bedtime Post Midnight

Data type

boolean

Alias
UMLS CUI [1]
C0231316
UMLS CUI [2]
C0555008
UMLS CUI [3,1]
C0521112
UMLS CUI [3,2]
C0687676
UMLS CUI [3,3]
C0332172
has uncontrolled hypertension at screening and day 1 prior to randomization; or any past history of hypertensive crisis
Description

Uncontrolled hypertension | Hypertensive crisis

Data type

boolean

Alias
UMLS CUI [1]
C1868885
UMLS CUI [2]
C0020546
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Similar models

Eligibility Depressive Disorder, Major NCT02067299

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Major Depressive Disorder | Major Depressive Disorder Recurrent | Major depressive episode In the past
Item
participants with a current/recurrent or past episode of major depressive disorder (mdd) as established per mini international neuropsychiatric interview at screening or otherwise specified by the treating physician
boolean
C1269683 (UMLS CUI [1])
C1269683 (UMLS CUI [2,1])
C2945760 (UMLS CUI [2,2])
C0024517 (UMLS CUI [3,1])
C1444637 (UMLS CUI [3,2])
Selective Serotonin Reuptake Inhibitors Stable
Item
stably treated with selective serotonin re-uptake inhibitor /
boolean
C0360105 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
Serotonin and Norepinephrine Reuptake Inhibitors (SNRIs) Dose unchanged
Item
serotonin-norepinephrine reuptake inhibitor monotherapy, with no change in dose in the last 30 days before screening
boolean
C1579361 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0442739 (UMLS CUI [1,3])
Sleeplessness Polysomnography
Item
insomnia per polysomnography (a diagnostic test to measure and record physiologic variables like latency to persistent sleep, total sleep time, sleep efficiency, time spent awake, and total time spent in deep sleep, during sleep)
boolean
C0917801 (UMLS CUI [1,1])
C0162701 (UMLS CUI [1,2])
Healthy Volunteers Laboratory Procedures | Stable status Medical Laboratory Procedures
Item
participants must be healthy / medically stable on the basis of clinical laboratory tests performed at screening
boolean
C1708335 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
C0205360 (UMLS CUI [2,1])
C0205476 (UMLS CUI [2,2])
C0022885 (UMLS CUI [2,3])
Gender Childbearing Potential Absent | Tubal Ligation | Hysterectomy | Postmenopausal state | Menses Spontaneous Absent
Item
female participants should not be of child bearing potential due to either tubal ligation or hysterectomy or who are postmenopausal (no spontaneous menses for at least 2 years)
boolean
C0079399 (UMLS CUI [1,1])
C3831118 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0520483 (UMLS CUI [2])
C0020699 (UMLS CUI [3])
C0232970 (UMLS CUI [4])
C0025344 (UMLS CUI [5,1])
C0205359 (UMLS CUI [5,2])
C0332197 (UMLS CUI [5,3])
Item Group
C0680251 (UMLS CUI)
Psychotic Disorder | Major Depressive Disorder with Psychotic Disorder | Bipolar Disorder | Mental Retardation | Personality Disorders | Borderline Personality Disorder | Antisocial Personality Disorder
Item
has a current diagnosis of a psychotic disorder, mdd with psychosis, bipolar disorder, mental retardation, or cluster b personality disorder (eg, borderline personality disorders, antisocial personality disorder)
boolean
C0033975 (UMLS CUI [1])
C1269683 (UMLS CUI [2,1])
C0332287 (UMLS CUI [2,2])
C0033975 (UMLS CUI [2,3])
C0005586 (UMLS CUI [3])
C0025362 (UMLS CUI [4])
C0031212 (UMLS CUI [5])
C0006012 (UMLS CUI [6])
C0003431 (UMLS CUI [7])
Abnormal breathing Sleep Related
Item
has been diagnosed with sleep-related breathing disorder
boolean
C1260922 (UMLS CUI [1,1])
C0037313 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Feeling suicidal | Suicidal intent | Homicidal thoughts | Homicidal intent
Item
has suicidal ideation with some intent to act, or has homicidal ideation/intent, per principal investigator's clinical judgment
boolean
C0424000 (UMLS CUI [1])
C0582496 (UMLS CUI [2])
C0455204 (UMLS CUI [3])
C2046965 (UMLS CUI [4])
Abnormal circadian rhythm | Night shift worker | Bedtime Post Midnight
Item
abnormal day/night rhythm, eg, nightshift worker, or normal bed time past midnight
boolean
C0231316 (UMLS CUI [1])
C0555008 (UMLS CUI [2])
C0521112 (UMLS CUI [3,1])
C0687676 (UMLS CUI [3,2])
C0332172 (UMLS CUI [3,3])
Uncontrolled hypertension | Hypertensive crisis
Item
has uncontrolled hypertension at screening and day 1 prior to randomization; or any past history of hypertensive crisis
boolean
C1868885 (UMLS CUI [1])
C0020546 (UMLS CUI [2])
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