ID

22007

Descrição

Pilot Study of Betahistine Dihydrochloride in the Treatment of Major Depression With Atypical Features; ODM derived from: https://clinicaltrials.gov/show/NCT00585585

Link

https://clinicaltrials.gov/show/NCT00585585

Palavras-chave

Versões (1)
  1. 14/05/2017 14/05/2017 -
Transferido a

14 de maio de 2017

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Major Depression, Atypical Features NCT00585585

Inglês

Eligibility Major Depression, Atypical Features NCT00585585

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. have signed written informed consent
Descrição

informed consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
2. be male and/or female outpatients 18 65 years of age, inclusive
Descrição

age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
3. for women: must be surgically sterile, 2 years postmenopausal, or, if they have childbearing potential, using a medically accepted method of birth control and agree to continue use of this method for at least 30 days after the last dose of study drug (i.e., barrier method with spermicide, steroidal contraceptive or intrauterine device [iud])
Descrição

effective contraception

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0700589
4. meet dsm iv1 criteria for major depressive episode (unipolar), with atypical features
Descrição

major depressive episode with atypical features

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0520669
UMLS CUI [1,2]
C0220952
5. have a score of 20 or greater on the hamilton depression rating, 28-item version (ham-d-28)
Descrição

hamilton depression rating scale

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0451203
6. have a complete medical and psychiatric history, physical examination, laboratory evaluation, and ecg before study entry.
Descrição

medical and psychiatric history, physical examination, laboratory, ecg

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0262926
UMLS CUI [2]
C0748059
UMLS CUI [3]
C0031809
UMLS CUI [4]
C0022877
UMLS CUI [5]
C1623258
7. have baseline laboratory values and ecg that are normal, or abnormalities that are clinically insignificant
Descrição

laboratory, ecg

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0022877
UMLS CUI [2]
C1623258
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. have significant and/or unstable gastrointestinal, neurological, endocrine, cardiovascular, pulmonary, renal, hepatic, immunological or hematological disease; organic brain disease; or cancer as determined by history, physical, ecg, and laboratory examination
Descrição

gastrointestinal, neurological, endocrine, cardiovascular, pulmonary, renal, hepatic, immunological, hematolgical, organic brain disease, cancer

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0017178
UMLS CUI [2]
C0027765
UMLS CUI [3]
C0014130
UMLS CUI [4]
C0007222
UMLS CUI [5]
C0024115
UMLS CUI [6]
C0022658
UMLS CUI [7]
C0023895
UMLS CUI [8]
C00210533
UMLS CUI [9]
C0018939
UMLS CUI [10,1]
C0006111
UMLS CUI [10,2]
C0747055
UMLS CUI [11]
C0006826
2. have a history of peptic ulcer disease
Descrição

peptic ulcer disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0030920
3. have a history of severe asthma
Descrição

asthma

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0004096
4. have a current diagnosis of pheochromocytoma
Descrição

pheochromocytoma

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0031511
5. are pregnant, intending to become pregnant, nursing, at risk for pregnancy, or not practicing medically acceptable birth control. (a blood pregnancy test will be performed at the screening visit)
Descrição

pregnancy, breast feeding, effective contraception, pregnancy test

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0700589
UMLS CUI [4]
C0032976
6. meet criteria for dsm iv1 psychoactive substance abuse or dependence in the past month
Descrição

substance use disorders dsm iv

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0038586
UMLS CUI [1,2]
C0220952
7. have a history of a psychotic disorder
Descrição

psychotic disorder

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0033975
8. use any medications that, in the judgment of the investigator, might have psychotropic effects, or interact unfavorably with betahistine dihydrochloride including centrally acting antihistaminic agents
Descrição

psychotropic drugs, interaction with betahistine dihydrochloride

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0033978
UMLS CUI [2,1]
C0687133
UMLS CUI [2,2]
C0282071
9. have a history of hypersensitivity to betahistine dihydrochloride
Descrição

betahistine dihydrochloride hypersensitivity

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0282071
UMLS CUI [1,2]
C0020517
10. exhibit, or suggestion that they may display, behavior that will not be conducive to the study procedures
Descrição

compliance behaviour

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1321605
11. are at significant risk of suicide as indicated by a score of 3 or greater on item number 11 on the ham-d 28
Descrição

suicide risk

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1271074
12. have received any investigational product within 28 days of screening
Descrição

investigational drug

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0013230
13. have used any antidepressant within 7 days of screening (14 days for maois; 21 days for fluoxetine)
Descrição

antidepressants

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0003289
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Similar models

Eligibility Major Depression, Atypical Features NCT00585585

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
informed consent
Item
1. have signed written informed consent
boolean
C0021430 (UMLS CUI [1])
age
Item
2. be male and/or female outpatients 18 65 years of age, inclusive
boolean
C0001779 (UMLS CUI [1])
effective contraception
Item
3. for women: must be surgically sterile, 2 years postmenopausal, or, if they have childbearing potential, using a medically accepted method of birth control and agree to continue use of this method for at least 30 days after the last dose of study drug (i.e., barrier method with spermicide, steroidal contraceptive or intrauterine device [iud])
boolean
C0700589 (UMLS CUI [1])
major depressive episode with atypical features
Item
4. meet dsm iv1 criteria for major depressive episode (unipolar), with atypical features
boolean
C0520669 (UMLS CUI [1,1])
C0220952 (UMLS CUI [1,2])
hamilton depression rating scale
Item
5. have a score of 20 or greater on the hamilton depression rating, 28-item version (ham-d-28)
boolean
C0451203 (UMLS CUI [1])
medical and psychiatric history, physical examination, laboratory, ecg
Item
6. have a complete medical and psychiatric history, physical examination, laboratory evaluation, and ecg before study entry.
boolean
C0262926 (UMLS CUI [1])
C0748059 (UMLS CUI [2])
C0031809 (UMLS CUI [3])
C0022877 (UMLS CUI [4])
C1623258 (UMLS CUI [5])
laboratory, ecg
Item
7. have baseline laboratory values and ecg that are normal, or abnormalities that are clinically insignificant
boolean
C0022877 (UMLS CUI [1])
C1623258 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
gastrointestinal, neurological, endocrine, cardiovascular, pulmonary, renal, hepatic, immunological, hematolgical, organic brain disease, cancer
Item
1. have significant and/or unstable gastrointestinal, neurological, endocrine, cardiovascular, pulmonary, renal, hepatic, immunological or hematological disease; organic brain disease; or cancer as determined by history, physical, ecg, and laboratory examination
boolean
C0017178 (UMLS CUI [1])
C0027765 (UMLS CUI [2])
C0014130 (UMLS CUI [3])
C0007222 (UMLS CUI [4])
C0024115 (UMLS CUI [5])
C0022658 (UMLS CUI [6])
C0023895 (UMLS CUI [7])
C00210533 (UMLS CUI [8])
C0018939 (UMLS CUI [9])
C0006111 (UMLS CUI [10,1])
C0747055 (UMLS CUI [10,2])
C0006826 (UMLS CUI [11])
peptic ulcer disease
Item
2. have a history of peptic ulcer disease
boolean
C0030920 (UMLS CUI [1])
asthma
Item
3. have a history of severe asthma
boolean
C0004096 (UMLS CUI [1])
pheochromocytoma
Item
4. have a current diagnosis of pheochromocytoma
boolean
C0031511 (UMLS CUI [1])
pregnancy, breast feeding, effective contraception, pregnancy test
Item
5. are pregnant, intending to become pregnant, nursing, at risk for pregnancy, or not practicing medically acceptable birth control. (a blood pregnancy test will be performed at the screening visit)
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0700589 (UMLS CUI [3])
C0032976 (UMLS CUI [4])
substance use disorders dsm iv
Item
6. meet criteria for dsm iv1 psychoactive substance abuse or dependence in the past month
boolean
C0038586 (UMLS CUI [1,1])
C0220952 (UMLS CUI [1,2])
psychotic disorder
Item
7. have a history of a psychotic disorder
boolean
C0033975 (UMLS CUI [1])
psychotropic drugs, interaction with betahistine dihydrochloride
Item
8. use any medications that, in the judgment of the investigator, might have psychotropic effects, or interact unfavorably with betahistine dihydrochloride including centrally acting antihistaminic agents
boolean
C0033978 (UMLS CUI [1])
C0687133 (UMLS CUI [2,1])
C0282071 (UMLS CUI [2,2])
betahistine dihydrochloride hypersensitivity
Item
9. have a history of hypersensitivity to betahistine dihydrochloride
boolean
C0282071 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
compliance behaviour
Item
10. exhibit, or suggestion that they may display, behavior that will not be conducive to the study procedures
boolean
C1321605 (UMLS CUI [1])
suicide risk
Item
11. are at significant risk of suicide as indicated by a score of 3 or greater on item number 11 on the ham-d 28
boolean
C1271074 (UMLS CUI [1])
investigational drug
Item
12. have received any investigational product within 28 days of screening
boolean
C0013230 (UMLS CUI [1])
antidepressants
Item
13. have used any antidepressant within 7 days of screening (14 days for maois; 21 days for fluoxetine)
boolean
C0003289 (UMLS CUI [1])
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