ID

30466

Descrição

Augmentation of the Antidepressant Action of Sertraline With Triiodothyronine (T3)and Reboxetine: Clinical Efficacy, Adverse Effects and Predictors of Response.; ODM derived from: https://clinicaltrials.gov/show/NCT00421369

Link

https://clinicaltrials.gov/show/NCT00421369

Palavras-chave

Versões (1)
  1. 06/06/2018 06/06/2018 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

6 de junho de 2018

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Major Depressive Disorder NCT00421369

Inglês

Eligibility Major Depressive Disorder NCT00421369

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. diagnosis of major depressive episode (mde) in the context mdd according to dsm-iv criteria, without psychotic features.
Descrição

Major depressive episode | DEPRESSIVE DISORDER MAJOR WITHOUT PSYCHOTIC FEATURE

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0024517
UMLS CUI [2]
C0743081
2. hamilton depression scale (21 items, ham-d) total >16 with item 1 (depressed mood) >2.
Descrição

Hamilton Depression Rating Scale 21-Item Clinical Classification | Depressed mood

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3640518
UMLS CUI [2]
C0344315
3. age 18-70 years.
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
4. male or female.
Descrição

Gender

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0079399
5. competent and willing to give written informed consent.
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. clinical hyper- or hypothyroidism or any other thyroid illness.
Descrição

Hyperthyroidism | Hypothyroidism | Thyroid Diseases

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0020550
UMLS CUI [2]
C0020676
UMLS CUI [3]
C0040128
2. neurological or other medical illness that may impact upon the study or limit prescription of the study medications.
Descrição

Nervous system disorder Impact Clinical Trial | Illness Impact Clinical Trial | Nervous system disorder Limiting Prescription Investigational New Drugs | Illness Limiting Prescription Investigational New Drugs

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0027765
UMLS CUI [1,2]
C4049986
UMLS CUI [1,3]
C0008976
UMLS CUI [2,1]
C0221423
UMLS CUI [2,2]
C4049986
UMLS CUI [2,3]
C0008976
UMLS CUI [3,1]
C0027765
UMLS CUI [3,2]
C0439801
UMLS CUI [3,3]
C0033080
UMLS CUI [3,4]
C0013230
UMLS CUI [4,1]
C0221423
UMLS CUI [4,2]
C0439801
UMLS CUI [4,3]
C0033080
UMLS CUI [4,4]
C0013230
3. significant suicidal risk [ham-d item 3 (suicide) >2].
Descrição

At risk for suicide Hamilton rating scale for depression

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0563664
UMLS CUI [1,2]
C0451203
4. comorbidity with any psychotic disorder, bipolar disorder, post traumatic stress disorder (ptsd), eating disorder.
Descrição

Comorbidity | Psychotic Disorder | Bipolar Disorder | Post-Traumatic Stress Disorder | Eating Disorder

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2]
C0033975
UMLS CUI [3]
C0005586
UMLS CUI [4]
C0038436
UMLS CUI [5]
C0013473
5. lifetime history of substance or alcohol dependence or of abuse in the preceding 12 months.
Descrição

Substance Dependence Lifetime | Substance Use Disorders

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0038580
UMLS CUI [1,2]
C4071830
UMLS CUI [2]
C0038586
6. treatment with the antidepressant, sertraline, in current episode.
Descrição

Sertraline | Depressive episode

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0074393
UMLS CUI [2]
C0349217
7. more then one antidepressant trial or any augmentation treatment during current episode.
Descrição

Antidepressive Agents | Therapeutic procedure Quantity | Therapeutic procedure Increased | Depressive episode

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0003289
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C1265611
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C0205217
UMLS CUI [4]
C0349217
8. length of current episode >12 months
Descrição

Depressive episode length

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0349217
UMLS CUI [1,2]
C0872146
9. female subjects pregnant or lactating or not using adequate contraception.
Descrição

Pregnancy | Breast Feeding | Gender Contraceptive methods Absent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C0332197
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Similar models

Eligibility Major Depressive Disorder NCT00421369

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Major depressive episode | DEPRESSIVE DISORDER MAJOR WITHOUT PSYCHOTIC FEATURE
Item
1. diagnosis of major depressive episode (mde) in the context mdd according to dsm-iv criteria, without psychotic features.
boolean
C0024517 (UMLS CUI [1])
C0743081 (UMLS CUI [2])
Hamilton Depression Rating Scale 21-Item Clinical Classification | Depressed mood
Item
2. hamilton depression scale (21 items, ham-d) total >16 with item 1 (depressed mood) >2.
boolean
C3640518 (UMLS CUI [1])
C0344315 (UMLS CUI [2])
Age
Item
3. age 18-70 years.
boolean
C0001779 (UMLS CUI [1])
Gender
Item
4. male or female.
boolean
C0079399 (UMLS CUI [1])
Informed Consent
Item
5. competent and willing to give written informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Hyperthyroidism | Hypothyroidism | Thyroid Diseases
Item
1. clinical hyper- or hypothyroidism or any other thyroid illness.
boolean
C0020550 (UMLS CUI [1])
C0020676 (UMLS CUI [2])
C0040128 (UMLS CUI [3])
Nervous system disorder Impact Clinical Trial | Illness Impact Clinical Trial | Nervous system disorder Limiting Prescription Investigational New Drugs | Illness Limiting Prescription Investigational New Drugs
Item
2. neurological or other medical illness that may impact upon the study or limit prescription of the study medications.
boolean
C0027765 (UMLS CUI [1,1])
C4049986 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0221423 (UMLS CUI [2,1])
C4049986 (UMLS CUI [2,2])
C0008976 (UMLS CUI [2,3])
C0027765 (UMLS CUI [3,1])
C0439801 (UMLS CUI [3,2])
C0033080 (UMLS CUI [3,3])
C0013230 (UMLS CUI [3,4])
C0221423 (UMLS CUI [4,1])
C0439801 (UMLS CUI [4,2])
C0033080 (UMLS CUI [4,3])
C0013230 (UMLS CUI [4,4])
At risk for suicide Hamilton rating scale for depression
Item
3. significant suicidal risk [ham-d item 3 (suicide) >2].
boolean
C0563664 (UMLS CUI [1,1])
C0451203 (UMLS CUI [1,2])
Comorbidity | Psychotic Disorder | Bipolar Disorder | Post-Traumatic Stress Disorder | Eating Disorder
Item
4. comorbidity with any psychotic disorder, bipolar disorder, post traumatic stress disorder (ptsd), eating disorder.
boolean
C0009488 (UMLS CUI [1])
C0033975 (UMLS CUI [2])
C0005586 (UMLS CUI [3])
C0038436 (UMLS CUI [4])
C0013473 (UMLS CUI [5])
Substance Dependence Lifetime | Substance Use Disorders
Item
5. lifetime history of substance or alcohol dependence or of abuse in the preceding 12 months.
boolean
C0038580 (UMLS CUI [1,1])
C4071830 (UMLS CUI [1,2])
C0038586 (UMLS CUI [2])
Sertraline | Depressive episode
Item
6. treatment with the antidepressant, sertraline, in current episode.
boolean
C0074393 (UMLS CUI [1])
C0349217 (UMLS CUI [2])
Antidepressive Agents | Therapeutic procedure Quantity | Therapeutic procedure Increased | Depressive episode
Item
7. more then one antidepressant trial or any augmentation treatment during current episode.
boolean
C0003289 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0087111 (UMLS CUI [3,1])
C0205217 (UMLS CUI [3,2])
C0349217 (UMLS CUI [4])
Depressive episode length
Item
8. length of current episode >12 months
boolean
C0349217 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Pregnancy | Breast Feeding | Gender Contraceptive methods Absent
Item
9. female subjects pregnant or lactating or not using adequate contraception.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0079399 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
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