ID

19550

Beschreibung

Phase II Study to Assess RG2417 in the Treatment of Bipolar I Depression; ODM derived from: https://clinicaltrials.gov/show/NCT00322764

Link

https://clinicaltrials.gov/show/NCT00322764

Stichworte

Versionen (1)
  1. 09.01.17 09.01.17 -
Hochgeladen am

9. Januar 2017

DOI

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Eligibility Bipolar Depression NCT00322764

Englisch

Eligibility Bipolar Depression NCT00322764

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. dsm-iv-tr diagnosis of bipolar i depression
Beschreibung

Depression, Bipolar

Datentyp

boolean

Alias
UMLS CUI [1]
C0005587
2. 18 to 65 years of age, inclusive
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
3. depressive phase, as measured by madrs greater than or equal to 20 at screening and day1
Beschreibung

Depressive episode Montgomery-Asberg Depression Rating Scale Questionnaire

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0349217
UMLS CUI [1,2]
C4054475
4. duration of current depressive episode of at least four weeks by day 1
Beschreibung

Depressive episode Duration

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0349217
UMLS CUI [1,2]
C0449238
5. competent to give informed consent
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. manic/hypomanic/mixed episode as determined by the mini at screening and/or a young mania rating scale (ymrs) score of > 12 at screening and/or day 1
Beschreibung

Manic episode Mini-mental state examination | hypomanic episode Mini-mental state examination | Episode Mixed Mini-mental state examination | Young Mania Rating Scale Questionnaire

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0349208
UMLS CUI [1,2]
C0451306
UMLS CUI [2,1]
C1396834
UMLS CUI [2,2]
C0451306
UMLS CUI [3,1]
C0332189
UMLS CUI [3,2]
C0205430
UMLS CUI [3,3]
C0451306
UMLS CUI [4]
C3640523
2. dementia or any current axis i diagnosis (excluding bipolar i) requiring pharmacological treatments
Beschreibung

Dementia Requirement Pharmacotherapy | Axis I diagnosis Requirement Pharmacotherapy | Bipolar I disorder

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0497327
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0013216
UMLS CUI [2,1]
C0270287
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0013216
UMLS CUI [3]
C0853193
3. a history of alcohol or substance dependence within six months of day 1, or a history of alcohol or substance abuse within three months of day 1
Beschreibung

Substance Dependence | Substance Use Disorders

Datentyp

boolean

Alias
UMLS CUI [1]
C0038580
UMLS CUI [2]
C0038586
4. urine drug screen positive for amphetamines, cocaine metabolites, opiates and/or phencyclindine (pcp)
Beschreibung

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

Datentyp

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
5. an axis ii diagnosis that is likely to interfere with protocol compliance
Beschreibung

Axis II diagnosis Interferes with Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0270288
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0525058
6. initiation of or increase in psychotherapy within 4 weeks of screening
Beschreibung

Psychotherapy Initiation | Psychotherapy Increase

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0033968
UMLS CUI [1,2]
C1704686
UMLS CUI [2,1]
C0033968
UMLS CUI [2,2]
C0442805
7. psychotropic medication (excluding fluoxetine) within 24 hours of initiation of study drug on day 1; fluoxetine within 2 weeks of initiation of study drug on day 1
Beschreibung

Psychotropic Drugs | Fluoxetine

Datentyp

boolean

Alias
UMLS CUI [1]
C0033978
UMLS CUI [2]
C0016365
8. serious suicidal or homicidal risk as determined by the investigator and/or a score of > 5 on the suicide item #10 of the madrs at screening and/or day 1
Beschreibung

At risk for suicide Serious Montgomery-Asberg Depression Rating Scale Questionnaire | Homicide Risk Serious Montgomery-Asberg Depression Rating Scale Questionnaire

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0563664
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C4054475
UMLS CUI [2,1]
C0019872
UMLS CUI [2,2]
C0035647
UMLS CUI [2,3]
C0205404
UMLS CUI [2,4]
C4054475
9. history of sensitivity to any of the ingredients in the study drug
Beschreibung

Hypersensitivity Investigational New Drug Ingredient

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C1550600
10. clinically significant abnormality in any screening laboratory results
Beschreibung

Laboratory test result abnormal Clinical Significance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0438215
UMLS CUI [1,2]
C2826293
11. clinically significant organic disease, including cardiovascular, endocrine, hepatic, pulmonary, neurologic, or renal disease, or any other medical condition, serious intercurrent illness, or extenuating circumstances that, in the opinion of the investigator, would interfere with the performance or interpretability of, or put the patient at risk from, the study procedures
Beschreibung

Organic disease Clinical Significance | Cardiovascular Diseases | Endocrine System Diseases | Liver diseases | Lung diseases | nervous system disorder | Kidney Diseases | Medical condition Interferes with Study Protocol | Illness Serious Interferes with Study Protocol

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0683324
UMLS CUI [1,2]
C2826293
UMLS CUI [2]
C0007222
UMLS CUI [3]
C0014130
UMLS CUI [4]
C0023895
UMLS CUI [5]
C0024115
UMLS CUI [6]
C0027765
UMLS CUI [7]
C0022658
UMLS CUI [8,1]
C3843040
UMLS CUI [8,2]
C0521102
UMLS CUI [8,3]
C2348563
UMLS CUI [9,1]
C0221423
UMLS CUI [9,2]
C0205404
UMLS CUI [9,3]
C0521102
UMLS CUI [9,4]
C2348563
12. women who are pregnant, breastfeeding, or refuse to use adequate birth control
Beschreibung

Pregnancy | Breast Feeding | Gender Contraceptive methods Refused

Datentyp

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
13. current seizure disorder
Beschreibung

Epilepsy

Datentyp

boolean

Alias
UMLS CUI [1]
C0014544
14. participation in an investigational drug study within twenty-eight days of day 1
Beschreibung

Study Subject Participation Status | Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
15. current psychotic episode
Beschreibung

Psychotic episode

Datentyp

boolean

Alias
UMLS CUI [1]
C0338614
16. clozaril use and/or electroconvulsive therapy within six months of day 1
Beschreibung

Clozaril | Electroconvulsive Therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0719386
UMLS CUI [2]
C0013806
17. failure of three or more adequate trials of standard therapies for depression during the current episode
Beschreibung

Depressive disorder Standard of Care Quantity failed

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0011581
UMLS CUI [1,2]
C2936643
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C0231175
18. current episode of depression is longer than one year
Beschreibung

Depressive episode Duration

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0349217
UMLS CUI [1,2]
C0449238
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Ähnliche Modelle

Eligibility Bipolar Depression NCT00322764

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Depression, Bipolar
Item
1. dsm-iv-tr diagnosis of bipolar i depression
boolean
C0005587 (UMLS CUI [1])
Age
Item
2. 18 to 65 years of age, inclusive
boolean
C0001779 (UMLS CUI [1])
Depressive episode Montgomery-Asberg Depression Rating Scale Questionnaire
Item
3. depressive phase, as measured by madrs greater than or equal to 20 at screening and day1
boolean
C0349217 (UMLS CUI [1,1])
C4054475 (UMLS CUI [1,2])
Depressive episode Duration
Item
4. duration of current depressive episode of at least four weeks by day 1
boolean
C0349217 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Informed Consent
Item
5. competent to give informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Manic episode Mini-mental state examination | hypomanic episode Mini-mental state examination | Episode Mixed Mini-mental state examination | Young Mania Rating Scale Questionnaire
Item
1. manic/hypomanic/mixed episode as determined by the mini at screening and/or a young mania rating scale (ymrs) score of > 12 at screening and/or day 1
boolean
C0349208 (UMLS CUI [1,1])
C0451306 (UMLS CUI [1,2])
C1396834 (UMLS CUI [2,1])
C0451306 (UMLS CUI [2,2])
C0332189 (UMLS CUI [3,1])
C0205430 (UMLS CUI [3,2])
C0451306 (UMLS CUI [3,3])
C3640523 (UMLS CUI [4])
Dementia Requirement Pharmacotherapy | Axis I diagnosis Requirement Pharmacotherapy | Bipolar I disorder
Item
2. dementia or any current axis i diagnosis (excluding bipolar i) requiring pharmacological treatments
boolean
C0497327 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0013216 (UMLS CUI [1,3])
C0270287 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0013216 (UMLS CUI [2,3])
C0853193 (UMLS CUI [3])
Substance Dependence | Substance Use Disorders
Item
3. a history of alcohol or substance dependence within six months of day 1, or a history of alcohol or substance abuse within three months of day 1
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
4. urine drug screen positive for amphetamines, cocaine metabolites, opiates and/or phencyclindine (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
5. an axis ii diagnosis that is likely to interfere with protocol compliance
boolean
C0270288 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
Psychotherapy Initiation | Psychotherapy Increase
Item
6. initiation of or increase in psychotherapy within 4 weeks of screening
boolean
C0033968 (UMLS CUI [1,1])
C1704686 (UMLS CUI [1,2])
C0033968 (UMLS CUI [2,1])
C0442805 (UMLS CUI [2,2])
Psychotropic Drugs | Fluoxetine
Item
7. psychotropic medication (excluding fluoxetine) within 24 hours of initiation of study drug on day 1; fluoxetine within 2 weeks of initiation of study drug on day 1
boolean
C0033978 (UMLS CUI [1])
C0016365 (UMLS CUI [2])
At risk for suicide Serious Montgomery-Asberg Depression Rating Scale Questionnaire | Homicide Risk Serious Montgomery-Asberg Depression Rating Scale Questionnaire
Item
8. serious suicidal or homicidal risk as determined by the investigator and/or a score of > 5 on the suicide item #10 of the madrs at screening and/or day 1
boolean
C0563664 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C4054475 (UMLS CUI [1,3])
C0019872 (UMLS CUI [2,1])
C0035647 (UMLS CUI [2,2])
C0205404 (UMLS CUI [2,3])
C4054475 (UMLS CUI [2,4])
Hypersensitivity Investigational New Drug Ingredient
Item
9. history of sensitivity to any of the ingredients in the study drug
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C1550600 (UMLS CUI [1,3])
Laboratory test result abnormal Clinical Significance
Item
10. clinically significant abnormality in any screening laboratory results
boolean
C0438215 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
Organic disease Clinical Significance | Cardiovascular Diseases | Endocrine System Diseases | Liver diseases | Lung diseases | nervous system disorder | Kidney Diseases | Medical condition Interferes with Study Protocol | Illness Serious Interferes with Study Protocol
Item
11. clinically significant organic disease, including cardiovascular, endocrine, hepatic, pulmonary, neurologic, or renal disease, or any other medical condition, serious intercurrent illness, or extenuating circumstances that, in the opinion of the investigator, would interfere with the performance or interpretability of, or put the patient at risk from, the study procedures
boolean
C0683324 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0007222 (UMLS CUI [2])
C0014130 (UMLS CUI [3])
C0023895 (UMLS CUI [4])
C0024115 (UMLS CUI [5])
C0027765 (UMLS CUI [6])
C0022658 (UMLS CUI [7])
C3843040 (UMLS CUI [8,1])
C0521102 (UMLS CUI [8,2])
C2348563 (UMLS CUI [8,3])
C0221423 (UMLS CUI [9,1])
C0205404 (UMLS CUI [9,2])
C0521102 (UMLS CUI [9,3])
C2348563 (UMLS CUI [9,4])
Pregnancy | Breast Feeding | Gender Contraceptive methods Refused
Item
12. women who are pregnant, breastfeeding, 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
13. current seizure disorder
boolean
C0014544 (UMLS CUI [1])
Study Subject Participation Status | Investigational New Drugs
Item
14. participation in an investigational drug study within twenty-eight days of day 1
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Psychotic episode
Item
15. current psychotic episode
boolean
C0338614 (UMLS CUI [1])
Clozaril | Electroconvulsive Therapy
Item
16. clozaril use and/or electroconvulsive therapy within six months of day 1
boolean
C0719386 (UMLS CUI [1])
C0013806 (UMLS CUI [2])
Depressive disorder Standard of Care Quantity failed
Item
17. failure of three or more adequate trials of standard therapies for depression during the current episode
boolean
C0011581 (UMLS CUI [1,1])
C2936643 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0231175 (UMLS CUI [1,4])
Depressive episode Duration
Item
18. current episode of depression is longer than one year
boolean
C0349217 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
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