ID

26005

Beschrijving

A Study to Assess the Safety, Tolerability and Efficacy of RG2417 in Bipolar I Depression; ODM derived from: https://clinicaltrials.gov/show/NCT00812058

Link

https://clinicaltrials.gov/show/NCT00812058

Trefwoorden

Versies (2)
  1. 02-10-17 02-10-17 -
  2. 04-10-17 04-10-17 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

4 oktober 2017

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Bipolar I Depression NCT00812058

Engels

Eligibility Bipolar I Depression NCT00812058

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
bipolar i disorder, most recent episode depressed
Beschrijving

Depressed bipolar I disorder

Datatype

boolean

Alias
UMLS CUI [1]
C0236773
history of 2 or more manic or mixed episodes, at least one of which required pharmacologic treatment for manic symptoms
Beschrijving

Manic episode Quantity | Mixed bipolar I disorder Quantity | Requirement Pharmacotherapy Manic symptoms

Datatype

boolean

Alias
UMLS CUI [1,1]
C0349208
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C0236780
UMLS CUI [2,2]
C1265611
UMLS CUI [3,1]
C1514873
UMLS CUI [3,2]
C0013216
UMLS CUI [3,3]
C0746402
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
current manic, hypomanic or mixed episode
Beschrijving

Manic episode | Hypomanic episode | Mixed bipolar I disorder

Datatype

boolean

Alias
UMLS CUI [1]
C0349208
UMLS CUI [2]
C1396834
UMLS CUI [3]
C0236780
rapid cycling bipolar disorder (4 or more mood episodes in the last year)
Beschrijving

Rapid cycling bipolar I disorder | Mood Episode Quantity

Datatype

boolean

Alias
UMLS CUI [1]
C2063820
UMLS CUI [2,1]
C0026516
UMLS CUI [2,2]
C0332189
UMLS CUI [2,3]
C1265611
dementia or any other axis i diagnosis (besides bipolar i) that requires treatment
Beschrijving

Dementia Treatment required for | Axis I diagnosis Treatment required for | Exception Bipolar I disorder

Datatype

boolean

Alias
UMLS CUI [1,1]
C0497327
UMLS CUI [1,2]
C0332121
UMLS CUI [2,1]
C0270287
UMLS CUI [2,2]
C0332121
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0853193
alcohol or drug dependence within 6 months; alcohol or drug abuse within 3 months
Beschrijving

Substance Dependence | Substance Use Disorders

Datatype

boolean

Alias
UMLS CUI [1]
C0038580
UMLS CUI [2]
C0038586
positive urine drug test for amphetamines, cocaine metabolites, opiates and/or phencyclidine(pcp)
Beschrijving

Urine drug screen positive Amphetamines | Urine drug screen positive Cocaine metabolite | Urine drug screen positive Opiates | Urine drug screen positive Phencyclidine

Datatype

boolean

Alias
UMLS CUI [1,1]
C0743300
UMLS CUI [1,2]
C0002667
UMLS CUI [2,1]
C0743300
UMLS CUI [2,2]
C1455816
UMLS CUI [3,1]
C0743300
UMLS CUI [3,2]
C0376196
UMLS CUI [4,1]
C0743300
UMLS CUI [4,2]
C0031381
axis ii diagnosis likely to interfere with study compliance
Beschrijving

Axis II diagnosis Interferes with Protocol Compliance

Datatype

boolean

Alias
UMLS CUI [1,1]
C0270288
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0525058
serious suicidal or homicidal risk
Beschrijving

At risk for suicide Serious | Homicide At risk Serious

Datatype

boolean

Alias
UMLS CUI [1,1]
C0563664
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C0019872
UMLS CUI [2,2]
C1444641
UMLS CUI [2,3]
C0205404
sensitivity to any of the drug ingredients, including lactose
Beschrijving

Hypersensitivity Investigational New Drug Ingredient | ALLERGY TO LACTOSE

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C1550600
UMLS CUI [2]
C0744078
women who are pregnant, breast feeding or refuse to use adequate birth control
Beschrijving

Pregnancy | Breast Feeding | Gender Contraceptive methods Refused

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C1705116
current seizure disorder
Beschrijving

Epilepsy

Datatype

boolean

Alias
UMLS CUI [1]
C0014544
current episode of depression is longer than 1 year
Beschrijving

Depressive disorder Episode Duration

Datatype

boolean

Alias
UMLS CUI [1,1]
C0011581
UMLS CUI [1,2]
C0332189
UMLS CUI [1,3]
C0449238
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Similar models

Eligibility Bipolar I Depression NCT00812058

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
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])
Item Group
C0680251 (UMLS CUI)
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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