ID

18070

Description

Effect of the Menstrual Cycle on the Symptoms of Depression and Treatment Response; ODM derived from: https://clinicaltrials.gov/show/NCT00188396

Link

https://clinicaltrials.gov/show/NCT00188396

Keywords

Versions (1)
  1. 10/18/16 10/18/16 -
Uploaded on

October 18, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Major Depressive Disorder NCT00188396

English

Eligibility Major Depressive Disorder NCT00188396

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
women, ages 18-65 years old
Description

Gender | Age

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
fulfilling dsm-iv criteria for major depressive disorder, which is not secondary to another pre-existing psychiatric condition or to a medical condition
Description

Major Depressive Disorder Secondary to Mental disorder Pre-existing | Major Depressive Disorder Secondary to Medical condition

Data type

boolean

Alias
UMLS CUI [1,1]
C1269683
UMLS CUI [1,2]
C0175668
UMLS CUI [1,3]
C0004936
UMLS CUI [1,4]
C2347662
UMLS CUI [2,1]
C1269683
UMLS CUI [2,2]
C0175668
UMLS CUI [2,3]
C3843040
hamilton depression rating scale (ham-d-17) total score of at least 16
Description

Hamilton rating scale for depression

Data type

boolean

Alias
UMLS CUI [1]
C0451203
able and willing to give meaningful written consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
28 women premenopausal (having monthly periods); 28 women perimenopausal (having irregular periods); and 28 women menopausal (without a period for at least one year).
Description

Gender Quantity | Premenopausal | Menstruation | Perimenopausal state | menstrual cycles usually irregular | Menopause | Menstruation Lacking

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C1265611
UMLS CUI [2]
C0279752
UMLS CUI [3]
C0025344
UMLS CUI [4]
C3839366
UMLS CUI [5]
C2128205
UMLS CUI [6]
C0025320
UMLS CUI [7,1]
C0025344
UMLS CUI [7,2]
C0332268
in good physical health.
Description

Overall Well Being

Data type

boolean

Alias
UMLS CUI [1]
C3813622
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects who are taking the birth control pill currently or within the last 3 months
Description

Contraceptives, Oral

Data type

boolean

Alias
UMLS CUI [1]
C0009905
subjects who plan to become pregnant or were pregnant within the last year
Description

Pregnancy, Planned | Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032992
UMLS CUI [2]
C0032961
subjects who are taking hormone replacement therapy (or received it within the last three [3] months)
Description

Hormone replacement therapy

Data type

boolean

Alias
UMLS CUI [1]
C0282402
subjects who meet dsm-iv criteria for substance abuse (consume > 4 alcoholic beverages per day)
Description

Substance Use Disorders | alcohol units/day

Data type

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0560578
subjects who have tried 2 antidepressants for this episode
Description

Antidepressive Agents Quantity Major depressive episode

Data type

boolean

Alias
UMLS CUI [1,1]
C0003289
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0024517
subjects who have additional diagnosed psychiatric conditions (i.e. anxiety, substance use and psychotic disorders)
Description

Mental disorders Additional | Anxiety | Substance Use Disorders | Psychotic Disorders

Data type

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C1524062
UMLS CUI [2]
C0003467
UMLS CUI [3]
C0038586
UMLS CUI [4]
C0033975
subjects who have had both ovaries surgically removed.
Description

Bilateral oophorectomy

Data type

boolean

Alias
UMLS CUI [1]
C0278321
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Similar models

Eligibility Major Depressive Disorder NCT00188396

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age
Item
women, ages 18-65 years old
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Major Depressive Disorder Secondary to Mental disorder Pre-existing | Major Depressive Disorder Secondary to Medical condition
Item
fulfilling dsm-iv criteria for major depressive disorder, which is not secondary to another pre-existing psychiatric condition or to a medical condition
boolean
C1269683 (UMLS CUI [1,1])
C0175668 (UMLS CUI [1,2])
C0004936 (UMLS CUI [1,3])
C2347662 (UMLS CUI [1,4])
C1269683 (UMLS CUI [2,1])
C0175668 (UMLS CUI [2,2])
C3843040 (UMLS CUI [2,3])
Hamilton rating scale for depression
Item
hamilton depression rating scale (ham-d-17) total score of at least 16
boolean
C0451203 (UMLS CUI [1])
Informed Consent
Item
able and willing to give meaningful written consent
boolean
C0021430 (UMLS CUI [1])
Gender Quantity | Premenopausal | Menstruation | Perimenopausal state | menstrual cycles usually irregular | Menopause | Menstruation Lacking
Item
28 women premenopausal (having monthly periods); 28 women perimenopausal (having irregular periods); and 28 women menopausal (without a period for at least one year).
boolean
C0079399 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0279752 (UMLS CUI [2])
C0025344 (UMLS CUI [3])
C3839366 (UMLS CUI [4])
C2128205 (UMLS CUI [5])
C0025320 (UMLS CUI [6])
C0025344 (UMLS CUI [7,1])
C0332268 (UMLS CUI [7,2])
Overall Well Being
Item
in good physical health.
boolean
C3813622 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Contraceptives, Oral
Item
subjects who are taking the birth control pill currently or within the last 3 months
boolean
C0009905 (UMLS CUI [1])
Pregnancy, Planned | Pregnancy
Item
subjects who plan to become pregnant or were pregnant within the last year
boolean
C0032992 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
Hormone replacement therapy
Item
subjects who are taking hormone replacement therapy (or received it within the last three [3] months)
boolean
C0282402 (UMLS CUI [1])
Substance Use Disorders | alcohol units/day
Item
subjects who meet dsm-iv criteria for substance abuse (consume > 4 alcoholic beverages per day)
boolean
C0038586 (UMLS CUI [1])
C0560578 (UMLS CUI [2])
Antidepressive Agents Quantity Major depressive episode
Item
subjects who have tried 2 antidepressants for this episode
boolean
C0003289 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0024517 (UMLS CUI [1,3])
Mental disorders Additional | Anxiety | Substance Use Disorders | Psychotic Disorders
Item
subjects who have additional diagnosed psychiatric conditions (i.e. anxiety, substance use and psychotic disorders)
boolean
C0004936 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
C0003467 (UMLS CUI [2])
C0038586 (UMLS CUI [3])
C0033975 (UMLS CUI [4])
Bilateral oophorectomy
Item
subjects who have had both ovaries surgically removed.
boolean
C0278321 (UMLS CUI [1])
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