ID

42685

Beschrijving

Biochemical Brain Changes Correlated With The Antidepressant Effect Of Thyroid Hormones; ODM derived from: https://clinicaltrials.gov/show/NCT00562367

Link

https://clinicaltrials.gov/show/NCT00562367

Trefwoorden

Versies (2)
  1. 25-07-16 25-07-16 -
  2. 17-09-21 17-09-21 -
Geüploaded op

17 september 2021

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Major Depressive Disorder NCT00562367

Engels

Eligibility Major Depressive Disorder NCT00562367

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
dsm-iv diagnostic criteria for mdd (diagnosed with the use of scid)
Beschrijving

major depressive disorder

Datatype

boolean

Alias
UMLS CUI [1]
C1269683
written informed consent
Beschrijving

written informed consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
men or women aged 18-65
Beschrijving

age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
a baseline hamilton-d17 score of > 16.
Beschrijving

baseline hamilton-d17 score

Datatype

boolean

Alias
UMLS CUI [1]
C0451203
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects with suicidal ideation where outpatient treatment is determined unsafe by the study clinician. these patients will be immediately referred to appropriate clinical treatment.
Beschrijving

suicidal ideation

Datatype

boolean

Alias
UMLS CUI [1]
C0424000
pregnant women or women of childbearing potential who are not using a medically accepted means of contraception (defined as oral contraceptive pill or implant, condom, diaphragm, spermicide, iud, s/p tubal ligation, partner with vasectomy)
Beschrijving

pregnancy or contraceptive methods

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0700589
serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease
Beschrijving

comorbidity

Datatype

boolean

Alias
UMLS CUI [1]
C0009488
history of seizure disorder,
Beschrijving

history of seizure disorder

Datatype

boolean

Alias
UMLS CUI [1]
C0014544
history or current diagnosis of the following dsm-iv psychiatric illness: organic mental disorder, schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorders not otherwise specified, bipolar disorder, patients with mood congruent or mood incongruent psychotic features, patients with substance dependence disorders, including alcohol, active within the last 12 months.
Beschrijving

psychiatric illness

Datatype

boolean

Alias
UMLS CUI [1]
C0004936
history or current diagnosis of dementia, or a score of < 26 on the mini mental status examination (folstein, 1975) at the screening visit.
Beschrijving

dementia or mini mental status examination

Datatype

boolean

Alias
UMLS CUI [1]
C0497327
UMLS CUI [2]
C0451306
history of multiple adverse drug reactions or allergy to the study drugs.
Beschrijving

multiple adverse drug reactions

Datatype

boolean

Alias
UMLS CUI [1]
C0041755
patients with mood congruent or mood incongruent psychotic features.
Beschrijving

mood psychotic features

Datatype

boolean

Alias
UMLS CUI [1]
C0086640
patients having shown minimal or no response to a standard course of antidepressant treatment with an ssri. a standard course will be defined as the following medications taken for > 4 weeks: fluoxetine > 20 mg/day, sertraline > 50 mg/day, paroxetine > 20 mg/day, fluvoxamine > 50 mg/day, citalopram > 20 mg/day, venlafaxine > 150 mg/day.
Beschrijving

no response to ssri

Datatype

boolean

Alias
UMLS CUI [1,1]
C0438286
UMLS CUI [1,2]
C0360105
clinical or laboratory evidence of hypothyroidism.
Beschrijving

hypothyroidism

Datatype

boolean

Alias
UMLS CUI [1]
C0020676
patients who have had electroconvulsive therapy (ect) within the 6 months preceding baseline.
Beschrijving

electroconvulsive therapy

Datatype

boolean

Alias
UMLS CUI [1]
C0013806
history of intolerance to cytomel
Beschrijving

intolerance to cytomel

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0010826
history of cardiac pathology or diabetes
Beschrijving

cardiac pathology or diabetes

Datatype

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2]
C0011849
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Similar models

Eligibility Major Depressive Disorder NCT00562367

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
major depressive disorder
Item
dsm-iv diagnostic criteria for mdd (diagnosed with the use of scid)
boolean
C1269683 (UMLS CUI [1])
written informed consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
age
Item
men or women aged 18-65
boolean
C0001779 (UMLS CUI [1])
baseline hamilton-d17 score
Item
a baseline hamilton-d17 score of > 16.
boolean
C0451203 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
suicidal ideation
Item
subjects with suicidal ideation where outpatient treatment is determined unsafe by the study clinician. these patients will be immediately referred to appropriate clinical treatment.
boolean
C0424000 (UMLS CUI [1])
pregnancy or contraceptive methods
Item
pregnant women or women of childbearing potential who are not using a medically accepted means of contraception (defined as oral contraceptive pill or implant, condom, diaphragm, spermicide, iud, s/p tubal ligation, partner with vasectomy)
boolean
C0032961 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
comorbidity
Item
serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease
boolean
C0009488 (UMLS CUI [1])
history of seizure disorder
Item
history of seizure disorder,
boolean
C0014544 (UMLS CUI [1])
psychiatric illness
Item
history or current diagnosis of the following dsm-iv psychiatric illness: organic mental disorder, schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorders not otherwise specified, bipolar disorder, patients with mood congruent or mood incongruent psychotic features, patients with substance dependence disorders, including alcohol, active within the last 12 months.
boolean
C0004936 (UMLS CUI [1])
dementia or mini mental status examination
Item
history or current diagnosis of dementia, or a score of < 26 on the mini mental status examination (folstein, 1975) at the screening visit.
boolean
C0497327 (UMLS CUI [1])
C0451306 (UMLS CUI [2])
multiple adverse drug reactions
Item
history of multiple adverse drug reactions or allergy to the study drugs.
boolean
C0041755 (UMLS CUI [1])
mood psychotic features
Item
patients with mood congruent or mood incongruent psychotic features.
boolean
C0086640 (UMLS CUI [1])
no response to ssri
Item
patients having shown minimal or no response to a standard course of antidepressant treatment with an ssri. a standard course will be defined as the following medications taken for > 4 weeks: fluoxetine > 20 mg/day, sertraline > 50 mg/day, paroxetine > 20 mg/day, fluvoxamine > 50 mg/day, citalopram > 20 mg/day, venlafaxine > 150 mg/day.
boolean
C0438286 (UMLS CUI [1,1])
C0360105 (UMLS CUI [1,2])
hypothyroidism
Item
clinical or laboratory evidence of hypothyroidism.
boolean
C0020676 (UMLS CUI [1])
electroconvulsive therapy
Item
patients who have had electroconvulsive therapy (ect) within the 6 months preceding baseline.
boolean
C0013806 (UMLS CUI [1])
intolerance to cytomel
Item
history of intolerance to cytomel
boolean
C0020517 (UMLS CUI [1,1])
C0010826 (UMLS CUI [1,2])
cardiac pathology or diabetes
Item
history of cardiac pathology or diabetes
boolean
C0018799 (UMLS CUI [1])
C0011849 (UMLS CUI [2])
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