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Information:
Fel:
ID
25961
Beskrivning
A Study to Assess the Safety, Tolerability and Efficacy of RG2417 in Bipolar I Depression; ODM derived from: https://clinicaltrials.gov/show/NCT00812058
Länk
https://clinicaltrials.gov/show/NCT00812058
Nyckelord
Versioner (2)
- 2017-10-02 2017-10-02 -
- 2017-10-04 2017-10-04 -
Rättsinnehavare
See clinicaltrials.gov
Uppladdad den
2 oktober 2017
DOI
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Licens
Creative Commons BY-NC 3.0
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Eligibility Bipolar I Depression NCT00812058
Eligibility Bipolar I Depression NCT00812058
- StudyEvent: Eligibility
Similar models
Eligibility Bipolar I Depression NCT00812058
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Depressed bipolar I disorder
Item
bipolar i disorder, most recent episode depressed
boolean
C0236773 (UMLS CUI [1])
Manic episode Quantity | Mixed bipolar I disorder Quantity | Requirement Pharmacotherapy Manic symptoms
Item
history of 2 or more manic or mixed episodes, at least one of which required pharmacologic treatment for manic symptoms
boolean
C0349208 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0236780 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C1514873 (UMLS CUI [3,1])
C0013216 (UMLS CUI [3,2])
C0746402 (UMLS CUI [3,3])
C1265611 (UMLS CUI [1,2])
C0236780 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C1514873 (UMLS CUI [3,1])
C0013216 (UMLS CUI [3,2])
C0746402 (UMLS CUI [3,3])
Manic episode | Hypomanic episode | Mixed bipolar I disorder
Item
current manic, hypomanic or mixed episode
boolean
C0349208 (UMLS CUI [1])
C1396834 (UMLS CUI [2])
C0236780 (UMLS CUI [3])
C1396834 (UMLS CUI [2])
C0236780 (UMLS CUI [3])
Rapid cycling bipolar I disorder | Mood Episode Quantity
Item
rapid cycling bipolar disorder (4 or more mood episodes in the last year)
boolean
C2063820 (UMLS CUI [1])
C0026516 (UMLS CUI [2,1])
C0332189 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0026516 (UMLS CUI [2,1])
C0332189 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
Dementia Treatment required for | Axis I diagnosis Treatment required for | Exception Bipolar I disorder
Item
dementia or any other axis i diagnosis (besides bipolar i) that requires treatment
boolean
C0497327 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
C0270287 (UMLS CUI [2,1])
C0332121 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0853193 (UMLS CUI [3,2])
C0332121 (UMLS CUI [1,2])
C0270287 (UMLS CUI [2,1])
C0332121 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0853193 (UMLS CUI [3,2])
Substance Dependence | Substance Use Disorders
Item
alcohol or drug dependence within 6 months; alcohol or drug abuse within 3 months
boolean
C0038580 (UMLS CUI [1])
C0038586 (UMLS CUI [2])
C0038586 (UMLS CUI [2])
Urine drug screen positive Amphetamines | Urine drug screen positive Cocaine metabolite | Urine drug screen positive Opiates | Urine drug screen positive Phencyclidine
Item
positive urine drug test for amphetamines, cocaine metabolites, opiates and/or phencyclidine(pcp)
boolean
C0743300 (UMLS CUI [1,1])
C0002667 (UMLS CUI [1,2])
C0743300 (UMLS CUI [2,1])
C1455816 (UMLS CUI [2,2])
C0743300 (UMLS CUI [3,1])
C0376196 (UMLS CUI [3,2])
C0743300 (UMLS CUI [4,1])
C0031381 (UMLS CUI [4,2])
C0002667 (UMLS CUI [1,2])
C0743300 (UMLS CUI [2,1])
C1455816 (UMLS CUI [2,2])
C0743300 (UMLS CUI [3,1])
C0376196 (UMLS CUI [3,2])
C0743300 (UMLS CUI [4,1])
C0031381 (UMLS CUI [4,2])
Axis II diagnosis Interferes with Protocol Compliance
Item
axis ii diagnosis likely to interfere with study compliance
boolean
C0270288 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C0521102 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
At risk for suicide Serious | Homicide At risk Serious
Item
serious suicidal or homicidal risk
boolean
C0563664 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0019872 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
C0205404 (UMLS CUI [2,3])
C0205404 (UMLS CUI [1,2])
C0019872 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
C0205404 (UMLS CUI [2,3])
Hypersensitivity Investigational New Drug Ingredient | ALLERGY TO LACTOSE
Item
sensitivity to any of the drug ingredients, including lactose
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C1550600 (UMLS CUI [1,3])
C0744078 (UMLS CUI [2])
C0013230 (UMLS CUI [1,2])
C1550600 (UMLS CUI [1,3])
C0744078 (UMLS CUI [2])
Pregnancy | Breast Feeding | Gender Contraceptive methods Refused
Item
women who are pregnant, breast feeding or refuse to use adequate birth control
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0079399 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C1705116 (UMLS CUI [3,3])
C0006147 (UMLS CUI [2])
C0079399 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C1705116 (UMLS CUI [3,3])
Epilepsy
Item
current seizure disorder
boolean
C0014544 (UMLS CUI [1])
Depressive disorder Episode Duration
Item
current episode of depression is longer than 1 year
boolean
C0011581 (UMLS CUI [1,1])
C0332189 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
C0332189 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])