ID

44405

Description

Lexapro for Major Depression in Patients With Epilepsy; ODM derived from: https://clinicaltrials.gov/show/NCT01244724

Link

https://clinicaltrials.gov/show/NCT01244724

Keywords

Versions (3)
  1. 6/5/18 6/5/18 -
  2. 6/5/18 6/5/18 -
  3. 9/20/21 9/20/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Major Depression NCT01244724

English

Eligibility Major Depression NCT01244724

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients will be 20 males or females above the age of 18 with a current major depressive episode, as defined by dsm-iv and assessed on the mini, of at least 4 weeks duration.
Description

Age | Major depressive episode Duration

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0024517
UMLS CUI [2,2]
C0449238
2. all subjects must have epilepsy, defined as the recurrence of seizures that are unprovoked and unpredictable, requiring treatment with an anti-epileptic medication under the care of a neurologist.
Description

Epilepsy | Requirement Antiepileptic Agents

Data type

boolean

Alias
UMLS CUI [1]
C0014544
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C0003299
3. subjects must be stabilized on their antiepileptic drug (aed) regimen for the previous 2 months.
Description

Antiepileptic Agents Stabilized

Data type

boolean

Alias
UMLS CUI [1,1]
C0003299
UMLS CUI [1,2]
C0184512
4. if a vagus nerve stimulator is in place, the settings must be unchanged for the previous 2 months.
Description

Insertion of vagal nerve stimulator | Setting unchanged

Data type

boolean

Alias
UMLS CUI [1]
C2919763
UMLS CUI [2,1]
C0815184
UMLS CUI [2,2]
C0442739
5. patients must be ages 18 - 75 and have a 24 item hamilton depression rating scale score (ham-d) at intake >/= 20.
Description

Age | Hamilton Depression Rating Scale-24 Item Clinical Classification

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C4330187
6. subjects must be fluent in english and have the capacity to understand the nature of the study and sign the written informed consent.
Description

Able to speak fluently English Language | Informed Consent

Data type

boolean

Alias
UMLS CUI [1,1]
C0564241
UMLS CUI [1,2]
C0376245
UMLS CUI [2]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. axis ii diagnosis of antisocial, schizotypal or severe borderline personality disorder(defined as patients who are high risk for being unable to complete the study due to hospitalization, suicide attempts, significant self-mutilation, or other self-injurious or destructive behavior).
Description

Axis II diagnosis | Antisocial Personality Disorder | Schizotypal Personality Disorder | Borderline Personality Disorder Severe | High risk Completion of clinical trial Unable | Hospitalization | Suicide attempt | Self Mutilation | Self-Injurious Behavior | Destructive behavior

Data type

boolean

Alias
UMLS CUI [1]
C0270288
UMLS CUI [2]
C0003431
UMLS CUI [3]
C0036363
UMLS CUI [4,1]
C0006012
UMLS CUI [4,2]
C0205082
UMLS CUI [5,1]
C0332167
UMLS CUI [5,2]
C2732579
UMLS CUI [5,3]
C1299582
UMLS CUI [6]
C0019993
UMLS CUI [7]
C0038663
UMLS CUI [8]
C0036601
UMLS CUI [9]
C0085271
UMLS CUI [10]
C0233520
2. history of psychosis, mania or hypomania.
Description

Psychotic Disorders | Mania | Hypomania

Data type

boolean

Alias
UMLS CUI [1]
C0033975
UMLS CUI [2]
C0338831
UMLS CUI [3]
C0241934
3. subjects with more than 10 seizures per month that involve impairment of consciousness, such as complex partial or generalized seizures.
Description

Seizures Quantity per month | Disturbance of consciousness | Complex partial seizures | Generalized seizures

Data type

boolean

Alias
UMLS CUI [1,1]
C0036572
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0332177
UMLS CUI [2]
C0234428
UMLS CUI [3]
C0149958
UMLS CUI [4]
C0234533
4. subjects unable to count seizures accurately, or do not have a someone in their home who can count seizures accurately .
Description

Seizures Count Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0036572
UMLS CUI [1,2]
C0750480
UMLS CUI [1,3]
C1299582
5. unstable medical or neurological disorder (other than epilepsy).
Description

Disease Unstable | Nervous system disorder Unstable | Exception Epilepsy

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0443343
UMLS CUI [2,1]
C0027765
UMLS CUI [2,2]
C0443343
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0014544
6. epilepsies related to a progressive neurologic disease such as a brain tumor.
Description

Epilepsy Relationship Nervous system disorder Progressive | Brain tumor

Data type

boolean

Alias
UMLS CUI [1,1]
C0014544
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0027765
UMLS CUI [1,4]
C0205329
UMLS CUI [2]
C0006118
7. substance abuse including etoh within the past 6 months.
Description

Substance Use Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0038586
8. need for concurrent psychotropic drugs with the exception of aeds or zolpidem for sleep.
Description

Patient need for Psychotropic Drugs | Exception Antiepileptic Agents | Exception Zolpidem Sleep

Data type

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C0033978
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0003299
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0078839
UMLS CUI [3,3]
C0037313
9. concurrent or recent (within 3 months) entry into a new psychotherapy.
Description

Psychotherapy New

Data type

boolean

Alias
UMLS CUI [1,1]
C0033968
UMLS CUI [1,2]
C0205314
10. actively or acutely suicidal.
Description

Suicidal

Data type

boolean

Alias
UMLS CUI [1]
C0438696
11. failure to respond to escitalopram or to two or more other adequate antidepressant trials in the past year.
Description

Escitalopram | Response failed | Antidepressive Agents | Attempt Quantity failed

Data type

boolean

Alias
UMLS CUI [1]
C1099456
UMLS CUI [2,1]
C1704632
UMLS CUI [2,2]
C0231175
UMLS CUI [3]
C0003289
UMLS CUI [4,1]
C1516084
UMLS CUI [4,2]
C1265611
UMLS CUI [4,3]
C0231175
12. pregnancy or lactation.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
13. females of child bearing potential who do not practice adequate contraception.
Description

Childbearing Potential Contraceptive methods Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0332197
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Similar models

Eligibility Major Depression NCT01244724

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age | Major depressive episode Duration
Item
1. patients will be 20 males or females above the age of 18 with a current major depressive episode, as defined by dsm-iv and assessed on the mini, of at least 4 weeks duration.
boolean
C0001779 (UMLS CUI [1])
C0024517 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
Epilepsy | Requirement Antiepileptic Agents
Item
2. all subjects must have epilepsy, defined as the recurrence of seizures that are unprovoked and unpredictable, requiring treatment with an anti-epileptic medication under the care of a neurologist.
boolean
C0014544 (UMLS CUI [1])
C1514873 (UMLS CUI [2,1])
C0003299 (UMLS CUI [2,2])
Antiepileptic Agents Stabilized
Item
3. subjects must be stabilized on their antiepileptic drug (aed) regimen for the previous 2 months.
boolean
C0003299 (UMLS CUI [1,1])
C0184512 (UMLS CUI [1,2])
Insertion of vagal nerve stimulator | Setting unchanged
Item
4. if a vagus nerve stimulator is in place, the settings must be unchanged for the previous 2 months.
boolean
C2919763 (UMLS CUI [1])
C0815184 (UMLS CUI [2,1])
C0442739 (UMLS CUI [2,2])
Age | Hamilton Depression Rating Scale-24 Item Clinical Classification
Item
5. patients must be ages 18 - 75 and have a 24 item hamilton depression rating scale score (ham-d) at intake >/= 20.
boolean
C0001779 (UMLS CUI [1])
C4330187 (UMLS CUI [2])
Able to speak fluently English Language | Informed Consent
Item
6. subjects must be fluent in english and have the capacity to understand the nature of the study and sign the written informed consent.
boolean
C0564241 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Axis II diagnosis | Antisocial Personality Disorder | Schizotypal Personality Disorder | Borderline Personality Disorder Severe | High risk Completion of clinical trial Unable | Hospitalization | Suicide attempt | Self Mutilation | Self-Injurious Behavior | Destructive behavior
Item
1. axis ii diagnosis of antisocial, schizotypal or severe borderline personality disorder(defined as patients who are high risk for being unable to complete the study due to hospitalization, suicide attempts, significant self-mutilation, or other self-injurious or destructive behavior).
boolean
C0270288 (UMLS CUI [1])
C0003431 (UMLS CUI [2])
C0036363 (UMLS CUI [3])
C0006012 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C0332167 (UMLS CUI [5,1])
C2732579 (UMLS CUI [5,2])
C1299582 (UMLS CUI [5,3])
C0019993 (UMLS CUI [6])
C0038663 (UMLS CUI [7])
C0036601 (UMLS CUI [8])
C0085271 (UMLS CUI [9])
C0233520 (UMLS CUI [10])
Psychotic Disorders | Mania | Hypomania
Item
2. history of psychosis, mania or hypomania.
boolean
C0033975 (UMLS CUI [1])
C0338831 (UMLS CUI [2])
C0241934 (UMLS CUI [3])
Seizures Quantity per month | Disturbance of consciousness | Complex partial seizures | Generalized seizures
Item
3. subjects with more than 10 seizures per month that involve impairment of consciousness, such as complex partial or generalized seizures.
boolean
C0036572 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0332177 (UMLS CUI [1,3])
C0234428 (UMLS CUI [2])
C0149958 (UMLS CUI [3])
C0234533 (UMLS CUI [4])
Seizures Count Unable
Item
4. subjects unable to count seizures accurately, or do not have a someone in their home who can count seizures accurately .
boolean
C0036572 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
Disease Unstable | Nervous system disorder Unstable | Exception Epilepsy
Item
5. unstable medical or neurological disorder (other than epilepsy).
boolean
C0012634 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0027765 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0014544 (UMLS CUI [3,2])
Epilepsy Relationship Nervous system disorder Progressive | Brain tumor
Item
6. epilepsies related to a progressive neurologic disease such as a brain tumor.
boolean
C0014544 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0027765 (UMLS CUI [1,3])
C0205329 (UMLS CUI [1,4])
C0006118 (UMLS CUI [2])
Substance Use Disorders
Item
7. substance abuse including etoh within the past 6 months.
boolean
C0038586 (UMLS CUI [1])
Patient need for Psychotropic Drugs | Exception Antiepileptic Agents | Exception Zolpidem Sleep
Item
8. need for concurrent psychotropic drugs with the exception of aeds or zolpidem for sleep.
boolean
C0686904 (UMLS CUI [1,1])
C0033978 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0003299 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0078839 (UMLS CUI [3,2])
C0037313 (UMLS CUI [3,3])
Psychotherapy New
Item
9. concurrent or recent (within 3 months) entry into a new psychotherapy.
boolean
C0033968 (UMLS CUI [1,1])
C0205314 (UMLS CUI [1,2])
Suicidal
Item
10. actively or acutely suicidal.
boolean
C0438696 (UMLS CUI [1])
Escitalopram | Response failed | Antidepressive Agents | Attempt Quantity failed
Item
11. failure to respond to escitalopram or to two or more other adequate antidepressant trials in the past year.
boolean
C1099456 (UMLS CUI [1])
C1704632 (UMLS CUI [2,1])
C0231175 (UMLS CUI [2,2])
C0003289 (UMLS CUI [3])
C1516084 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
C0231175 (UMLS CUI [4,3])
Pregnancy | Breast Feeding
Item
12. pregnancy or lactation.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Childbearing Potential Contraceptive methods Absent
Item
13. females of child bearing potential who do not practice adequate contraception.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
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