ID

16322

Descripción

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

Link

https://clinicaltrials.gov/show/NCT00033787

Palabras clave

Versiones (1)
  1. 11/7/16 11/7/16 -
Subido en

11 de julio de 2016

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Depression, Involutional NCT00033787

Inglés

Eligibility Depression, Involutional NCT00033787

1 formularios  
Criteria
Descripción

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.
Descripción

study description

Tipo de datos

boolean

inclusion criteria - healthy control samples:
Descripción

inclusion criteria

Tipo de datos

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.
Descripción

ID.3

Tipo de datos

boolean

Exclusion Criteria
Descripción

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.
Descripción

antidepressant medication

Tipo de datos

boolean

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

exclusion criteria

Tipo de datos

boolean

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

medical history of psychotic disorders

Tipo de datos

boolean

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

medical or neurological illnesses

Tipo de datos

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;
Descripción

History of substance abuse

Tipo de datos

boolean

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

current pregnancy

Tipo de datos

boolean

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

breast feeding

Tipo de datos

boolean

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

smoker

Tipo de datos

boolean

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

suicidal intent

Tipo de datos

boolean

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

mri exclusion criteria

Tipo de datos

boolean

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

alcohol consumption

Tipo de datos

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.
Descripción

ID.15

Tipo de datos

boolean

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

other current axis i diagnoses

Tipo de datos

boolean

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

lactose intolerance

Tipo de datos

boolean

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

age

Tipo de datos

boolean

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

secondary depressive episodes

Tipo de datos

boolean

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

Eligibility Depression, Involutional NCT00033787

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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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