ID

15605

Description

Testosterone and Major Depression; ODM derived from: https://clinicaltrials.gov/show/NCT00286546

Link

https://clinicaltrials.gov/show/NCT00286546

Keywords

Versions (1)
  1. 6/4/16 6/4/16 -
Uploaded on

June 4, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Major Depression NCT00286546

English

Eligibility Major Depression NCT00286546

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
meets dsm iv criteria for a diagnosis of major depressive disorder as per an assessment by the pren physician-investigator.
Description

major depressive disorder

Data type

boolean

Alias
UMLS CUI [1]
C1269683
subjects must have a hamilton depression rating scale (ham-d-17) of at least 16.
Description

hamilton depression rating scale

Data type

boolean

Alias
UMLS CUI [1]
C0451203
subjects must be male between the ages of 40 and 65.
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
subjects must be judged by the investigator to be in generally good health.
Description

generally good health

Data type

boolean

Alias
UMLS CUI [1,1]
C0018759
UMLS CUI [1,2]
C0205170
body mass index (bmi) between 20 to 29 kg/m2.
Description

BMI

Data type

boolean

Alias
UMLS CUI [1]
C1305855
able and willing to give meaningful written consent.
Description

written consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
educational level and a degree of understanding such that they can communicate effectively with the investigator.
Description

communication skills

Data type

boolean

Alias
UMLS CUI [1]
C0870313
subjects must have had normal sexual functioning prior to the onset of depression.
Description

normal sexual functioning

Data type

boolean

Alias
UMLS CUI [1,1]
C0278092
UMLS CUI [1,2]
C0205307
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects must not suffer from clinically significant medical conditions. examples include neurological, cardiovascular, gastrointestinal, hepatic, renal, haematological, respiratory or endocrine illnesses.
Description

significant medical conditions

Data type

boolean

Alias
UMLS CUI [1]
C0009488
recent history of drug or alcohol abuse/dependence within the past 6 months as defined by dsm-iv or in the opinion of the investigator.
Description

drug or alcohol abuse

Data type

boolean

Alias
UMLS CUI [1]
C0038586
uncorrected hypothyroidism or hyperthyroidism.
Description

hypothyroidism or hyperthyroidism

Data type

boolean

Alias
UMLS CUI [1]
C0020676
UMLS CUI [2]
C0020550
current use of hormone replacement therapy.
Description

hormone replacement therapy

Data type

boolean

Alias
UMLS CUI [1]
C0282402
current diagnosis of schizophrenia or other psychotic disorder (including psychotic disorder due to general medical condition, substance-induced psychotic disorder, psychotic disorder not otherwise specified) as defined in the dsm-iv.
Description

schizophrenia or other psychotic disorder

Data type

boolean

Alias
UMLS CUI [1]
C0036341
UMLS CUI [2]
C0033975
current diagnosis of depressive disorder not otherwise specified or bipolar i disorder, most recent episode major depression mixed or manic bipolar ii disorder as defined in the dsm-iv.
Description

depressive disorder not otherwise specified or bipolar i disorder

Data type

boolean

Alias
UMLS CUI [1]
C0011581
UMLS CUI [2]
C0853193
electroconvulsive therapy (ect) within the 3 months prior to visit 1.
Description

ECT

Data type

boolean

Alias
UMLS CUI [1]
C0013806
not currently on any antidepressants or must have an interval of the following prior to entry into the study: fluoxetine-4 weeks; maois- 2 weeks
Description

currently on any antidepressants

Data type

boolean

Alias
UMLS CUI [1]
C0003289
all other psychotic medications and herbal preparations with putative antidepressant properties (e.g. paroxetine hci, other antidepressant not specified above, st. john's wort, kava-kava or valerian: 1 week)
Description

all other psychotic medications

Data type

boolean

Alias
UMLS CUI [1]
C0003289
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Similar models

Eligibility Major Depression NCT00286546

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
major depressive disorder
Item
meets dsm iv criteria for a diagnosis of major depressive disorder as per an assessment by the pren physician-investigator.
boolean
C1269683 (UMLS CUI [1])
hamilton depression rating scale
Item
subjects must have a hamilton depression rating scale (ham-d-17) of at least 16.
boolean
C0451203 (UMLS CUI [1])
age
Item
subjects must be male between the ages of 40 and 65.
boolean
C0001779 (UMLS CUI [1])
generally good health
Item
subjects must be judged by the investigator to be in generally good health.
boolean
C0018759 (UMLS CUI [1,1])
C0205170 (UMLS CUI [1,2])
BMI
Item
body mass index (bmi) between 20 to 29 kg/m2.
boolean
C1305855 (UMLS CUI [1])
written consent
Item
able and willing to give meaningful written consent.
boolean
C0021430 (UMLS CUI [1])
communication skills
Item
educational level and a degree of understanding such that they can communicate effectively with the investigator.
boolean
C0870313 (UMLS CUI [1])
normal sexual functioning
Item
subjects must have had normal sexual functioning prior to the onset of depression.
boolean
C0278092 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
significant medical conditions
Item
subjects must not suffer from clinically significant medical conditions. examples include neurological, cardiovascular, gastrointestinal, hepatic, renal, haematological, respiratory or endocrine illnesses.
boolean
C0009488 (UMLS CUI [1])
drug or alcohol abuse
Item
recent history of drug or alcohol abuse/dependence within the past 6 months as defined by dsm-iv or in the opinion of the investigator.
boolean
C0038586 (UMLS CUI [1])
hypothyroidism or hyperthyroidism
Item
uncorrected hypothyroidism or hyperthyroidism.
boolean
C0020676 (UMLS CUI [1])
C0020550 (UMLS CUI [2])
hormone replacement therapy
Item
current use of hormone replacement therapy.
boolean
C0282402 (UMLS CUI [1])
schizophrenia or other psychotic disorder
Item
current diagnosis of schizophrenia or other psychotic disorder (including psychotic disorder due to general medical condition, substance-induced psychotic disorder, psychotic disorder not otherwise specified) as defined in the dsm-iv.
boolean
C0036341 (UMLS CUI [1])
C0033975 (UMLS CUI [2])
depressive disorder not otherwise specified or bipolar i disorder
Item
current diagnosis of depressive disorder not otherwise specified or bipolar i disorder, most recent episode major depression mixed or manic bipolar ii disorder as defined in the dsm-iv.
boolean
C0011581 (UMLS CUI [1])
C0853193 (UMLS CUI [2])
ECT
Item
electroconvulsive therapy (ect) within the 3 months prior to visit 1.
boolean
C0013806 (UMLS CUI [1])
currently on any antidepressants
Item
not currently on any antidepressants or must have an interval of the following prior to entry into the study: fluoxetine-4 weeks; maois- 2 weeks
boolean
C0003289 (UMLS CUI [1])
all other psychotic medications
Item
all other psychotic medications and herbal preparations with putative antidepressant properties (e.g. paroxetine hci, other antidepressant not specified above, st. john's wort, kava-kava or valerian: 1 week)
boolean
C0003289 (UMLS CUI [1])
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