ID

16322

Description

Serotonin Function During Depression; ODM derived from: https://clinicaltrials.gov/show/NCT00033787

Link

https://clinicaltrials.gov/show/NCT00033787

Keywords

Versions (1)
  1. 7/11/16 7/11/16 -
Uploaded on

July 11, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Depression, Involutional NCT00033787

English

Eligibility Depression, Involutional NCT00033787

1 forms  
Criteria
Description

Criteria

36 subjects with rmdd (ages 18-60) will be selected. remission is defined as a period of at least three months during which the subject has not taken an antidepressant agent, with hamilton depression rating scales (hdrs; 21-item) scores in the non-depressed range (less than 8), and with no more than one clinically significant depressive symptom. additional 17 subjects with current mdd will be selected for the gaba mrs study.
Description

study description

Data type

boolean

inclusion criteria - healthy control samples:
Description

inclusion criteria

Data type

boolean

Alias
UMLS CUI [1]
C1512693
twenty-four healthy subjects (ages 18-60) without a known personal or family history of psychiatric disorders in first-degree relatives will be selected.
Description

ID.3

Data type

boolean

Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects must not have taken antidepressant or other medications likely to alter monoamine neurochemistry or cerebrovascular and cardiovascular function for at least 3 months prior to the studies. however, effective medications will not be discontinued for the purposes of this study.
Description

antidepressant medication

Data type

boolean

Alias
UMLS CUI [1]
C0003289
subjects will also be excluded if they have:
Description

exclusion criteria

Data type

boolean

Alias
UMLS CUI [1]
C0680251
1. any form of past or current psychosis;
Description

medical history of psychotic disorders

Data type

boolean

Alias
UMLS CUI [1]
C3887134
2. medical or neurological illnesses likely to affect physiology or anatomy, i.e. hypertension, cardiovascular disorders;
Description

medical or neurological illnesses

Data type

boolean

Alias
UMLS CUI [1]
C0009488
3. a history of drug (including benzodiazepines [bzd]) or alcohol abuse within 1 year or a lifetime history of alcohol or drug dependence (dsm iv criteria) longer than 2 years;
Description

History of substance abuse

Data type

boolean

Alias
UMLS CUI [1]
C1299544
4. current pregnancy (as documented by pregnancy testing at screening or at days of the challenge studies);
Description

current pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0747843
f) current breast feeding (tryptophan depletion);
Description

breast feeding

Data type

boolean

Alias
UMLS CUI [1]
C0006147
g) are smokers;
Description

smoker

Data type

boolean

Alias
UMLS CUI [1]
C0037369
h) current suicidal ideation or behavior;
Description

suicidal intent

Data type

boolean

Alias
UMLS CUI [1]
C0582496
i) general mri exclusion criteria.
Description

mri exclusion criteria

Data type

boolean

Alias
UMLS CUI [1,1]
C0024485
UMLS CUI [1,2]
C0522473
subjects must exhibit no or only moderate alcohol use.
Description

alcohol consumption

Data type

boolean

Alias
UMLS CUI [1]
C0001948
subjects with current excessive use of alcohol (greater than 8 ounces/day for men and greater than 6 ounces/day for women) are ineligible for participation.
Description

ID.15

Data type

boolean

j) other current axis i diagnoses beside unipolar major depressive disorder;
Description

other current axis i diagnoses

Data type

boolean

Alias
UMLS CUI [1]
C0270287
k) lactose intolerance (tryptophan depletion).
Description

lactose intolerance

Data type

boolean

Alias
UMLS CUI [1]
C0022951
subjects beyond the age of 60 are excluded.
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
subjects whose first major depressive episodes arose temporally after other medical or psychiatric conditions will also be excluded.
Description

secondary depressive episodes

Data type

boolean

Alias
UMLS CUI [1,1]
C0011581
UMLS CUI [1,2]
C0277555
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Similar models

Eligibility Depression, Involutional NCT00033787

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
study description
Item
36 subjects with rmdd (ages 18-60) will be selected. remission is defined as a period of at least three months during which the subject has not taken an antidepressant agent, with hamilton depression rating scales (hdrs; 21-item) scores in the non-depressed range (less than 8), and with no more than one clinically significant depressive symptom. additional 17 subjects with current mdd will be selected for the gaba mrs study.
boolean
inclusion criteria
Item
inclusion criteria - healthy control samples:
boolean
C1512693 (UMLS CUI [1])
ID.3
Item
twenty-four healthy subjects (ages 18-60) without a known personal or family history of psychiatric disorders in first-degree relatives will be selected.
boolean
Item Group
C0680251 (UMLS CUI)
antidepressant medication
Item
subjects must not have taken antidepressant or other medications likely to alter monoamine neurochemistry or cerebrovascular and cardiovascular function for at least 3 months prior to the studies. however, effective medications will not be discontinued for the purposes of this study.
boolean
C0003289 (UMLS CUI [1])
exclusion criteria
Item
subjects will also be excluded if they have:
boolean
C0680251 (UMLS CUI [1])
medical history of psychotic disorders
Item
1. any form of past or current psychosis;
boolean
C3887134 (UMLS CUI [1])
medical or neurological illnesses
Item
2. medical or neurological illnesses likely to affect physiology or anatomy, i.e. hypertension, cardiovascular disorders;
boolean
C0009488 (UMLS CUI [1])
History of substance abuse
Item
3. a history of drug (including benzodiazepines [bzd]) or alcohol abuse within 1 year or a lifetime history of alcohol or drug dependence (dsm iv criteria) longer than 2 years;
boolean
C1299544 (UMLS CUI [1])
current pregnancy
Item
4. current pregnancy (as documented by pregnancy testing at screening or at days of the challenge studies);
boolean
C0747843 (UMLS CUI [1])
breast feeding
Item
f) current breast feeding (tryptophan depletion);
boolean
C0006147 (UMLS CUI [1])
smoker
Item
g) are smokers;
boolean
C0037369 (UMLS CUI [1])
suicidal intent
Item
h) current suicidal ideation or behavior;
boolean
C0582496 (UMLS CUI [1])
mri exclusion criteria
Item
i) general mri exclusion criteria.
boolean
C0024485 (UMLS CUI [1,1])
C0522473 (UMLS CUI [1,2])
alcohol consumption
Item
subjects must exhibit no or only moderate alcohol use.
boolean
C0001948 (UMLS CUI [1])
ID.15
Item
subjects with current excessive use of alcohol (greater than 8 ounces/day for men and greater than 6 ounces/day for women) are ineligible for participation.
boolean
other current axis i diagnoses
Item
j) other current axis i diagnoses beside unipolar major depressive disorder;
boolean
C0270287 (UMLS CUI [1])
lactose intolerance
Item
k) lactose intolerance (tryptophan depletion).
boolean
C0022951 (UMLS CUI [1])
age
Item
subjects beyond the age of 60 are excluded.
boolean
C0001779 (UMLS CUI [1])
secondary depressive episodes
Item
subjects whose first major depressive episodes arose temporally after other medical or psychiatric conditions will also be excluded.
boolean
C0011581 (UMLS CUI [1,1])
C0277555 (UMLS CUI [1,2])
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