ID

32589

Descrição

Ketamine Frequency Treatment for Major Depressive Disorder; ODM derived from: https://clinicaltrials.gov/show/NCT00646087

Link

https://clinicaltrials.gov/show/NCT00646087

Palavras-chave

Versões (1)
  1. 08/11/2018 08/11/2018 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

8 de novembro de 2018

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Treatment Resistant Depression NCT00646087

Inglês

Eligibility Treatment Resistant Depression NCT00646087

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
age 30 to 65
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
major depressive disorder without psychotic features confirmed by a structured clinical diagnostic interview, scid.
Descrição

DEPRESSIVE DISORDER MAJOR WITHOUT PSYCHOTIC FEATURE

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0743081
treatment resistant depression defined using the antidepressant treatment history form (athf)
Descrição

Depressive Disorder, Treatment-Resistant

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2063866
hdrs 21 score > 18
Descrição

Hamilton depression rating scale

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2021166
female participants of childbearing potential must be using a medically accepted means of contraception (birth control pills, spermicidal barrier)
Descrição

Childbearing Potential Contraceptive methods | Contraceptives, Oral | Contraception, Barrier | Vaginal Spermicides

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2]
C0009905
UMLS CUI [3]
C0004764
UMLS CUI [4]
C0087145
ability to concur with medication standardization regiment (section as an outpatient
Descrição

Pharmacotherapy Standardization | Outpatient

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C0038136
UMLS CUI [2]
C0029921
physically healthy (no chronic diseases; normal cbc, bmp, ast, alt, and ua)
Descrição

Healthy Physical | Chronic disease Absent | Full blood count normal | Basic metabolic panel Normal | AST level normal | Alanine aminotransferase normal | Uric acid normal

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3898900
UMLS CUI [1,2]
C0205485
UMLS CUI [2,1]
C0008679
UMLS CUI [2,2]
C0332197
UMLS CUI [3]
C0427692
UMLS CUI [4,1]
C2237045
UMLS CUI [4,2]
C0205307
UMLS CUI [5]
C0580474
UMLS CUI [6]
C0855620
UMLS CUI [7]
C1856341
competent to give informed consent to all required tests and examinations and sign a consent document
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
bipolar disorder
Descrição

Bipolar Disorder

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0005586
psychosis or any other psychotic disorder as defined by dsm-iv criteria
Descrição

Psychotic Disorders

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0033975
serious or imminent threat for suicide
Descrição

At risk for suicide Serious | At risk for suicide Impending

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0563664
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C0563664
UMLS CUI [2,2]
C0332190
pregnant or nursing female
Descrição

Pregnancy | Breast Feeding

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
presence of serious unstable medical illnesses including hepatic, renal, gastrointestinal, respiratory, cardiovascular, endocrinologic, neurologic, immunologic, or hematologic disease, or abnormal laboratory tests (cbc, bmp, ast, alt, and ua)
Descrição

Illness Serious Unstable | Liver diseases | Kidney Diseases | Gastrointestinal Diseases | Respiration Disorders | Cardiovascular Diseases | Endocrine System Diseases | Nervous system disorder | Immune System Diseases | Hematological Disease | Laboratory test result abnormal | CBC abnormal | Basic metabolic panel Abnormal | AST level abnormal | ALT level abnormal | Uric acid abnormal

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0443343
UMLS CUI [2]
C0023895
UMLS CUI [3]
C0022658
UMLS CUI [4]
C0017178
UMLS CUI [5]
C0035204
UMLS CUI [6]
C0007222
UMLS CUI [7]
C0014130
UMLS CUI [8]
C0027765
UMLS CUI [9]
C0021053
UMLS CUI [10]
C0018939
UMLS CUI [11]
C0438215
UMLS CUI [12]
C0742009
UMLS CUI [13,1]
C2237045
UMLS CUI [13,2]
C0205161
UMLS CUI [14]
C0580475
UMLS CUI [15]
C0580469
UMLS CUI [16]
C1868911
uncontrolled hypertension
Descrição

Uncontrolled hypertension

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1868885
history of cva
Descrição

Cerebrovascular accident

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0038454
treatment with st. johns wort, tramadol, phentolamine, naloxone, or anticholinergic medications
Descrição

Hypericum perforatum | Tramadol | Phentolamine | Naloxone | Anticholinergic Agents

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0936242
UMLS CUI [2]
C0040610
UMLS CUI [3]
C0031448
UMLS CUI [4]
C0027358
UMLS CUI [5]
C0242896
alcohol or illicit drug abuse for 6 months (evidence from uds)
Descrição

Alcohol abuse Urine drug screen | DRUG ABUSE ILLICIT Urine drug screen

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0085762
UMLS CUI [1,2]
C0202274
UMLS CUI [2,1]
C0743253
UMLS CUI [2,2]
C0202274
currently involved in a clinical trial or used an experimental medication within the last 30 days
Descrição

Study Subject Participation Status | Investigational New Drugs

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
hypersensitivity to ketamine products
Descrição

Ketamine allergy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0570631
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Similar models

Eligibility Treatment Resistant Depression NCT00646087

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age 30 to 65
boolean
C0001779 (UMLS CUI [1])
DEPRESSIVE DISORDER MAJOR WITHOUT PSYCHOTIC FEATURE
Item
major depressive disorder without psychotic features confirmed by a structured clinical diagnostic interview, scid.
boolean
C0743081 (UMLS CUI [1])
Depressive Disorder, Treatment-Resistant
Item
treatment resistant depression defined using the antidepressant treatment history form (athf)
boolean
C2063866 (UMLS CUI [1])
Hamilton depression rating scale
Item
hdrs 21 score > 18
boolean
C2021166 (UMLS CUI [1])
Childbearing Potential Contraceptive methods | Contraceptives, Oral | Contraception, Barrier | Vaginal Spermicides
Item
female participants of childbearing potential must be using a medically accepted means of contraception (birth control pills, spermicidal barrier)
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0009905 (UMLS CUI [2])
C0004764 (UMLS CUI [3])
C0087145 (UMLS CUI [4])
Pharmacotherapy Standardization | Outpatient
Item
ability to concur with medication standardization regiment (section as an outpatient
boolean
C0013216 (UMLS CUI [1,1])
C0038136 (UMLS CUI [1,2])
C0029921 (UMLS CUI [2])
Healthy Physical | Chronic disease Absent | Full blood count normal | Basic metabolic panel Normal | AST level normal | Alanine aminotransferase normal | Uric acid normal
Item
physically healthy (no chronic diseases; normal cbc, bmp, ast, alt, and ua)
boolean
C3898900 (UMLS CUI [1,1])
C0205485 (UMLS CUI [1,2])
C0008679 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0427692 (UMLS CUI [3])
C2237045 (UMLS CUI [4,1])
C0205307 (UMLS CUI [4,2])
C0580474 (UMLS CUI [5])
C0855620 (UMLS CUI [6])
C1856341 (UMLS CUI [7])
Informed Consent
Item
competent to give informed consent to all required tests and examinations and sign a consent document
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Bipolar Disorder
Item
bipolar disorder
boolean
C0005586 (UMLS CUI [1])
Psychotic Disorders
Item
psychosis or any other psychotic disorder as defined by dsm-iv criteria
boolean
C0033975 (UMLS CUI [1])
At risk for suicide Serious | At risk for suicide Impending
Item
serious or imminent threat for suicide
boolean
C0563664 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0563664 (UMLS CUI [2,1])
C0332190 (UMLS CUI [2,2])
Pregnancy | Breast Feeding
Item
pregnant or nursing female
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Illness Serious Unstable | Liver diseases | Kidney Diseases | Gastrointestinal Diseases | Respiration Disorders | Cardiovascular Diseases | Endocrine System Diseases | Nervous system disorder | Immune System Diseases | Hematological Disease | Laboratory test result abnormal | CBC abnormal | Basic metabolic panel Abnormal | AST level abnormal | ALT level abnormal | Uric acid abnormal
Item
presence of serious unstable medical illnesses including hepatic, renal, gastrointestinal, respiratory, cardiovascular, endocrinologic, neurologic, immunologic, or hematologic disease, or abnormal laboratory tests (cbc, bmp, ast, alt, and ua)
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0443343 (UMLS CUI [1,3])
C0023895 (UMLS CUI [2])
C0022658 (UMLS CUI [3])
C0017178 (UMLS CUI [4])
C0035204 (UMLS CUI [5])
C0007222 (UMLS CUI [6])
C0014130 (UMLS CUI [7])
C0027765 (UMLS CUI [8])
C0021053 (UMLS CUI [9])
C0018939 (UMLS CUI [10])
C0438215 (UMLS CUI [11])
C0742009 (UMLS CUI [12])
C2237045 (UMLS CUI [13,1])
C0205161 (UMLS CUI [13,2])
C0580475 (UMLS CUI [14])
C0580469 (UMLS CUI [15])
C1868911 (UMLS CUI [16])
Uncontrolled hypertension
Item
uncontrolled hypertension
boolean
C1868885 (UMLS CUI [1])
Cerebrovascular accident
Item
history of cva
boolean
C0038454 (UMLS CUI [1])
Hypericum perforatum | Tramadol | Phentolamine | Naloxone | Anticholinergic Agents
Item
treatment with st. johns wort, tramadol, phentolamine, naloxone, or anticholinergic medications
boolean
C0936242 (UMLS CUI [1])
C0040610 (UMLS CUI [2])
C0031448 (UMLS CUI [3])
C0027358 (UMLS CUI [4])
C0242896 (UMLS CUI [5])
Alcohol abuse Urine drug screen | DRUG ABUSE ILLICIT Urine drug screen
Item
alcohol or illicit drug abuse for 6 months (evidence from uds)
boolean
C0085762 (UMLS CUI [1,1])
C0202274 (UMLS CUI [1,2])
C0743253 (UMLS CUI [2,1])
C0202274 (UMLS CUI [2,2])
Study Subject Participation Status | Investigational New Drugs
Item
currently involved in a clinical trial or used an experimental medication within the last 30 days
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Ketamine allergy
Item
hypersensitivity to ketamine products
boolean
C0570631 (UMLS CUI [1])
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