ID

37698

Beschrijving

Lurasidone HCI - A 6-week Phase 3 Study of Patients With Bipolar I Depression; ODM derived from: https://clinicaltrials.gov/show/NCT01284517

Link

https://clinicaltrials.gov/show/NCT01284517

Trefwoorden

Versies (1)
  1. 18-08-19 18-08-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

18 augustus 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Bipolar Depression NCT01284517

Engels

Eligibility Bipolar Depression NCT01284517

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. provide written informed consent and is 18 to 75 years of age inclusive.
Beschrijving

Informed Consent | Age

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C0001779
2. meets dsm-iv-tr criteria for bipolar i disorder, most recent episode depressed (≥ 4 weeks and less than 12 months) without psychotic features.
Beschrijving

Bipolar I disorder | Depressive episode Without Psychotic feature

Datatype

boolean

Alias
UMLS CUI [1]
C0853193
UMLS CUI [2,1]
C0349217
UMLS CUI [2,2]
C0332288
UMLS CUI [2,3]
C0743076
3. has a lifetime history of at least one bipolar manic or mixed manic episode.
Beschrijving

Manic episode Bipolar Quantity Lifetime | Mixed manic depressive episode Quantity Lifetime

Datatype

boolean

Alias
UMLS CUI [1,1]
C0349208
UMLS CUI [1,2]
C0443156
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C4071830
UMLS CUI [2,1]
C1608433
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C4071830
4. currently being treated with lithium or divalproex or willing to begin treatment with lithium or divalproex.
Beschrijving

Lithium | Valproic Acid | Lithium Treatment Willing | Valproic Acid Treatment Willing

Datatype

boolean

Alias
UMLS CUI [1]
C0023870
UMLS CUI [2]
C0042291
UMLS CUI [3,1]
C0023870
UMLS CUI [3,2]
C0087111
UMLS CUI [3,3]
C0600109
UMLS CUI [4,1]
C0042291
UMLS CUI [4,2]
C0087111
UMLS CUI [4,3]
C0600109
5. not pregnant or nursing and is not planning pregnancy within the projected duration of the study.
Beschrijving

Pregnancy Absent | Breast Feeding Absent | Planned Pregnancy Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0006147
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0032992
UMLS CUI [3,2]
C0332197
6. females of reproductive potential agree to remain abstinent or use adequate and reliable contraception throughout the study and for at least 30 days after
Beschrijving

Childbearing Potential Sexual Abstinence | Childbearing Potential Contraceptive methods

Datatype

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0036899
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
7. good physical health on the basis of medical history, physical examination, and laboratory screening.
Beschrijving

Physical Health Good Medical History | Physical Health Good Physical Examination | Physical Health Good Laboratory Screening

Datatype

boolean

Alias
UMLS CUI [1,1]
C0517226
UMLS CUI [1,2]
C0205170
UMLS CUI [1,3]
C0262926
UMLS CUI [2,1]
C0517226
UMLS CUI [2,2]
C0205170
UMLS CUI [2,3]
C0031809
UMLS CUI [3,1]
C0517226
UMLS CUI [3,2]
C0205170
UMLS CUI [3,3]
C4542589
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. subject is considered by the investigator to be at imminent risk of suicide or injury to self, others, or property.
Beschrijving

At risk for suicide | At risk Self-harm | Risk of harm to others | At risk Damage Property

Datatype

boolean

Alias
UMLS CUI [1]
C0563664
UMLS CUI [2,1]
C1444641
UMLS CUI [2,2]
C0424366
UMLS CUI [3]
C0549013
UMLS CUI [4,1]
C1444641
UMLS CUI [4,2]
C1883709
UMLS CUI [4,3]
C2347695
2. any chronic organic disease of the cns (other than bipolar i disorder).
Beschrijving

CNS disorder chronic | Exception Bipolar I disorder

Datatype

boolean

Alias
UMLS CUI [1,1]
C0007682
UMLS CUI [1,2]
C0205191
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0853193
3. hospitalization for a manic or mixed episode within the past two months.
Beschrijving

Hospitalization Manic episode | Hospitalization Mixed manic depressive episode

Datatype

boolean

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C0349208
UMLS CUI [2,1]
C0019993
UMLS CUI [2,2]
C1608433
4. used investigational compound within past 6 months.
Beschrijving

Compound Investigational

Datatype

boolean

Alias
UMLS CUI [1,1]
C1706082
UMLS CUI [1,2]
C1517586
5. clinically significant history of alcohol or substance abuse within the past 3 months or alcohol or substance dependence within the past 12 months.
Beschrijving

Substance Use Disorders | Substance Dependence

Datatype

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0038580
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Similar models

Eligibility Bipolar Depression NCT01284517

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent | Age
Item
1. provide written informed consent and is 18 to 75 years of age inclusive.
boolean
C0021430 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Bipolar I disorder | Depressive episode Without Psychotic feature
Item
2. meets dsm-iv-tr criteria for bipolar i disorder, most recent episode depressed (≥ 4 weeks and less than 12 months) without psychotic features.
boolean
C0853193 (UMLS CUI [1])
C0349217 (UMLS CUI [2,1])
C0332288 (UMLS CUI [2,2])
C0743076 (UMLS CUI [2,3])
Manic episode Bipolar Quantity Lifetime | Mixed manic depressive episode Quantity Lifetime
Item
3. has a lifetime history of at least one bipolar manic or mixed manic episode.
boolean
C0349208 (UMLS CUI [1,1])
C0443156 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C4071830 (UMLS CUI [1,4])
C1608433 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C4071830 (UMLS CUI [2,3])
Lithium | Valproic Acid | Lithium Treatment Willing | Valproic Acid Treatment Willing
Item
4. currently being treated with lithium or divalproex or willing to begin treatment with lithium or divalproex.
boolean
C0023870 (UMLS CUI [1])
C0042291 (UMLS CUI [2])
C0023870 (UMLS CUI [3,1])
C0087111 (UMLS CUI [3,2])
C0600109 (UMLS CUI [3,3])
C0042291 (UMLS CUI [4,1])
C0087111 (UMLS CUI [4,2])
C0600109 (UMLS CUI [4,3])
Pregnancy Absent | Breast Feeding Absent | Planned Pregnancy Absent
Item
5. not pregnant or nursing and is not planning pregnancy within the projected duration of the study.
boolean
C0032961 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0032992 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Childbearing Potential Sexual Abstinence | Childbearing Potential Contraceptive methods
Item
6. females of reproductive potential agree to remain abstinent or use adequate and reliable contraception throughout the study and for at least 30 days after
boolean
C3831118 (UMLS CUI [1,1])
C0036899 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Physical Health Good Medical History | Physical Health Good Physical Examination | Physical Health Good Laboratory Screening
Item
7. good physical health on the basis of medical history, physical examination, and laboratory screening.
boolean
C0517226 (UMLS CUI [1,1])
C0205170 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,3])
C0517226 (UMLS CUI [2,1])
C0205170 (UMLS CUI [2,2])
C0031809 (UMLS CUI [2,3])
C0517226 (UMLS CUI [3,1])
C0205170 (UMLS CUI [3,2])
C4542589 (UMLS CUI [3,3])
Item Group
C0680251 (UMLS CUI)
At risk for suicide | At risk Self-harm | Risk of harm to others | At risk Damage Property
Item
1. subject is considered by the investigator to be at imminent risk of suicide or injury to self, others, or property.
boolean
C0563664 (UMLS CUI [1])
C1444641 (UMLS CUI [2,1])
C0424366 (UMLS CUI [2,2])
C0549013 (UMLS CUI [3])
C1444641 (UMLS CUI [4,1])
C1883709 (UMLS CUI [4,2])
C2347695 (UMLS CUI [4,3])
CNS disorder chronic | Exception Bipolar I disorder
Item
2. any chronic organic disease of the cns (other than bipolar i disorder).
boolean
C0007682 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0853193 (UMLS CUI [2,2])
Hospitalization Manic episode | Hospitalization Mixed manic depressive episode
Item
3. hospitalization for a manic or mixed episode within the past two months.
boolean
C0019993 (UMLS CUI [1,1])
C0349208 (UMLS CUI [1,2])
C0019993 (UMLS CUI [2,1])
C1608433 (UMLS CUI [2,2])
Compound Investigational
Item
4. used investigational compound within past 6 months.
boolean
C1706082 (UMLS CUI [1,1])
C1517586 (UMLS CUI [1,2])
Substance Use Disorders | Substance Dependence
Item
5. clinically significant history of alcohol or substance abuse within the past 3 months or alcohol or substance dependence within the past 12 months.
boolean
C0038586 (UMLS CUI [1])
C0038580 (UMLS CUI [2])
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