ID

15448

Descrição

5-hydroxytryptophan and Creatine for Treatment Resistant Depression Associated With Hypoxia in Females; ODM derived from: https://clinicaltrials.gov/show/NCT02356107

Link

https://clinicaltrials.gov/show/NCT02356107

Palavras-chave

Versões (1)
  1. 01/06/2016 01/06/2016 -
Transferido a

1 de junho de 2016

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Major Depressive Disorder NCT02356107

Inglês

Eligibility Major Depressive Disorder NCT02356107

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
female gender, ages 18-64 years inclusive
Descrição

Gender | Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
current diagnosis of major depressive disorder identified by the scid-5-ct
Descrição

Major Depressive Disorder Structured Clinical Interview

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1269683
UMLS CUI [1,2]
C0935589
current ham-d17 score of > 15
Descrição

Hamilton rating scale for depression

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0451203
adequate adherence to any fda approved ssri for at least 8 weeks
Descrição

Selective Serotonin Reuptake Inhibitors Adherence | FDA Approved

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0360105
UMLS CUI [1,2]
C1510802
UMLS CUI [2,1]
C0041714
UMLS CUI [2,2]
C0205540
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
diagnosis of bipolar disorder, schizophrenia, or schizoaffective disorder, identified by the scid-5-ct
Descrição

Bipolar Disorder | Schizophrenia | Schizoaffective Disorder | Structured Clinical Interview

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0005586
UMLS CUI [2]
C0036341
UMLS CUI [3]
C0036337
UMLS CUI [4]
C0935589
history of or current diagnosis of renal disease, such as chronic renal failure, acute renal failure or end stage renal disease
Descrição

Kidney Diseases | End stage renal disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0022658
UMLS CUI [2]
C0022661
diabetes type i or ii
Descrição

Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C0011860
colitis or diverticulitis
Descrição

Colitis | Diverticulitis

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0009319
UMLS CUI [2]
C0012813
history of pulmonary disease
Descrição

Lung diseases

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0024115
history of fibromyalgia, lupus, eosinophilia myalgia syndrome, dermatomyositis, polymyositis, rheumatoid arthritis, psoriatic arthritis, mixed connective tissue disease, ankylosing spondylitis, or other related rheumatological condition
Descrição

Fibromyalgia | Lupus Erythematosus | Eosinophilia-Myalgia Syndrome | Dermatomyositis | Polymyositis | Rheumatoid Arthritis | Arthritis, Psoriatic | Mixed Connective Tissue Disease | Ankylosing spondylitis

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0016053
UMLS CUI [2]
C0409974
UMLS CUI [3]
C0085179
UMLS CUI [4]
C0011633
UMLS CUI [5]
C0085655
UMLS CUI [6]
C0003873
UMLS CUI [7]
C0003872
UMLS CUI [8]
C0026272
UMLS CUI [9]
C0038013
seizure disorder
Descrição

Epilepsy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0014544
current serious suicide risk identified by the columbia severity suicide rating scale
Descrição

At risk for suicide Serious | Columbia suicide severity rating scale

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0563664
UMLS CUI [1,2]
C0205404
UMLS CUI [2]
C3888485
current treatment with an antipsychotic, mood stabilizer, or non-ssri antidepressant
Descrição

Antipsychotic Agents | Mood Stabilizer | Antidepressive Agents | Selective Serotonin Reuptake Inhibitors | Therapeutic procedure

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0040615
UMLS CUI [2]
C2917435
UMLS CUI [3]
C0003289
UMLS CUI [4]
C0360105
UMLS CUI [5]
C0087111
positive pregnancy test
Descrição

Pregnancy test positive

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0240802
previous diagnosis of serotonin syndrome
Descrição

Serotonin Syndrome Prior diagnosis

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0699828
UMLS CUI [1,2]
C0332132
use of any excluded drugs or medications including serotonergic drugs or medications
Descrição

Pharmaceutical Preparations Excluded Use | Serotonin Agents

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C2828389
UMLS CUI [1,3]
C1524063
UMLS CUI [2]
C0242701
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Similar models

Eligibility Major Depressive Disorder NCT02356107

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age
Item
female gender, ages 18-64 years inclusive
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Major Depressive Disorder Structured Clinical Interview
Item
current diagnosis of major depressive disorder identified by the scid-5-ct
boolean
C1269683 (UMLS CUI [1,1])
C0935589 (UMLS CUI [1,2])
Hamilton rating scale for depression
Item
current ham-d17 score of > 15
boolean
C0451203 (UMLS CUI [1])
Selective Serotonin Reuptake Inhibitors Adherence | FDA Approved
Item
adequate adherence to any fda approved ssri for at least 8 weeks
boolean
C0360105 (UMLS CUI [1,1])
C1510802 (UMLS CUI [1,2])
C0041714 (UMLS CUI [2,1])
C0205540 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Bipolar Disorder | Schizophrenia | Schizoaffective Disorder | Structured Clinical Interview
Item
diagnosis of bipolar disorder, schizophrenia, or schizoaffective disorder, identified by the scid-5-ct
boolean
C0005586 (UMLS CUI [1])
C0036341 (UMLS CUI [2])
C0036337 (UMLS CUI [3])
C0935589 (UMLS CUI [4])
Kidney Diseases | End stage renal disease
Item
history of or current diagnosis of renal disease, such as chronic renal failure, acute renal failure or end stage renal disease
boolean
C0022658 (UMLS CUI [1])
C0022661 (UMLS CUI [2])
Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent
Item
diabetes type i or ii
boolean
C0011854 (UMLS CUI [1])
C0011860 (UMLS CUI [2])
Colitis | Diverticulitis
Item
colitis or diverticulitis
boolean
C0009319 (UMLS CUI [1])
C0012813 (UMLS CUI [2])
Lung diseases
Item
history of pulmonary disease
boolean
C0024115 (UMLS CUI [1])
Fibromyalgia | Lupus Erythematosus | Eosinophilia-Myalgia Syndrome | Dermatomyositis | Polymyositis | Rheumatoid Arthritis | Arthritis, Psoriatic | Mixed Connective Tissue Disease | Ankylosing spondylitis
Item
history of fibromyalgia, lupus, eosinophilia myalgia syndrome, dermatomyositis, polymyositis, rheumatoid arthritis, psoriatic arthritis, mixed connective tissue disease, ankylosing spondylitis, or other related rheumatological condition
boolean
C0016053 (UMLS CUI [1])
C0409974 (UMLS CUI [2])
C0085179 (UMLS CUI [3])
C0011633 (UMLS CUI [4])
C0085655 (UMLS CUI [5])
C0003873 (UMLS CUI [6])
C0003872 (UMLS CUI [7])
C0026272 (UMLS CUI [8])
C0038013 (UMLS CUI [9])
Epilepsy
Item
seizure disorder
boolean
C0014544 (UMLS CUI [1])
At risk for suicide Serious | Columbia suicide severity rating scale
Item
current serious suicide risk identified by the columbia severity suicide rating scale
boolean
C0563664 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C3888485 (UMLS CUI [2])
Antipsychotic Agents | Mood Stabilizer | Antidepressive Agents | Selective Serotonin Reuptake Inhibitors | Therapeutic procedure
Item
current treatment with an antipsychotic, mood stabilizer, or non-ssri antidepressant
boolean
C0040615 (UMLS CUI [1])
C2917435 (UMLS CUI [2])
C0003289 (UMLS CUI [3])
C0360105 (UMLS CUI [4])
C0087111 (UMLS CUI [5])
Pregnancy test positive
Item
positive pregnancy test
boolean
C0240802 (UMLS CUI [1])
Serotonin Syndrome Prior diagnosis
Item
previous diagnosis of serotonin syndrome
boolean
C0699828 (UMLS CUI [1,1])
C0332132 (UMLS CUI [1,2])
Pharmaceutical Preparations Excluded Use | Serotonin Agents
Item
use of any excluded drugs or medications including serotonergic drugs or medications
boolean
C0013227 (UMLS CUI [1,1])
C2828389 (UMLS CUI [1,2])
C1524063 (UMLS CUI [1,3])
C0242701 (UMLS CUI [2])
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