ID

30466

Descrizione

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

collegamento

https://clinicaltrials.gov/show/NCT00421369

Keywords

  1. 06/06/18 06/06/18 -
Titolare del copyright

See clinicaltrials.gov

Caricato su

6 giugno 2018

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY 4.0

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Eligibility Major Depressive Disorder NCT00421369

Eligibility Major Depressive Disorder NCT00421369

Inclusion Criteria
Descrizione

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.
Descrizione

Major depressive episode | DEPRESSIVE DISORDER MAJOR WITHOUT PSYCHOTIC FEATURE

Tipo di dati

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.
Descrizione

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

Tipo di dati

boolean

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

Age

Tipo di dati

boolean

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

Gender

Tipo di dati

boolean

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

Informed Consent

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrizione

Exclusion Criteria

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

Hyperthyroidism | Hypothyroidism | Thyroid Diseases

Tipo di dati

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.
Descrizione

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 di dati

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].
Descrizione

At risk for suicide Hamilton rating scale for depression

Tipo di dati

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.
Descrizione

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

Tipo di dati

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.
Descrizione

Substance Dependence Lifetime | Substance Use Disorders

Tipo di dati

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.
Descrizione

Sertraline | Depressive episode

Tipo di dati

boolean

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

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

Tipo di dati

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
Descrizione

Depressive episode length

Tipo di dati

boolean

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

Pregnancy | Breast Feeding | Gender Contraceptive methods Absent

Tipo di dati

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

Similar models

Eligibility Major Depressive Disorder NCT00421369

Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
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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