ID

18841

Description

The Effects of Estrogen Withdrawal on Mood Symptoms in Women; ODM derived from: https://clinicaltrials.gov/show/NCT00060736

Link

https://clinicaltrials.gov/show/NCT00060736

Keywords

Versions (2)
  1. 11/22/16 11/22/16 -
  2. 9/20/21 9/20/21 -
Uploaded on

November 22, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Perimenopausal Depression NCT00060736

English

Eligibility Perimenopausal Depression NCT00060736

1 forms  
Criteria
Description

Criteria

all subjects for this protocol will be either self-referred in response to newspaper advertisements or referred by their personal physician. the women participating in this protocol will have previously completed the screening protocol # 88-m-0131 and, therefore, will have had the presence or absence of perimenopausal or menopausal reproductive status evaluated and documented.
Description

Perimenopausal state Evaluated | Menopausal Reproductive Status Evaluated

Data type

boolean

Alias
UMLS CUI [1,1]
C3839366
UMLS CUI [1,2]
C0220825
UMLS CUI [2,1]
C1513126
UMLS CUI [2,2]
C0035150
UMLS CUI [2,3]
C0220825
1. women with a past perimenopause-related depression (within 12 years) and whose depression responded to et will be recruited to participate in this randomized, parallel-design, double-blind, placebo-controlled study. women with histories of either perimenopausal depression that was not responsive to et or hormone replacement therapy-induced dysphoria due to either the estrogen or the progesterone components of their hormone replacement will be excluded. the diagnosis of perimenopause-related depression will be based on a history of a past depressive episode (major or minor depression confirmed by structured clinical interview for dsm-iv (scid) or schedule of affective disorders and schizophrenia-lifetime version (sads-l), respectively) at midlife in association with menstrual cycle irregularity and the history of remission (also confirmed by scid or sads-l) of this depression after et. additionally, all women will report that they were placed on hrt for the treatment of perimenopausal symptoms, including depression.
Description

Depression perimenopausal | Depressive disorder Responsive Estrogen therapy | Dysphoria Hormone replacement therapy Induced | Depressive episode Middle Age | Major Depressive Disorder | Minor depressive disorder | Menstruation Disturbances | Depressive disorder remission | Hormone replacement therapy Perimenopausal symptoms

Data type

boolean

Alias
UMLS CUI [1]
C1963857
UMLS CUI [2,1]
C0011581
UMLS CUI [2,2]
C0205342
UMLS CUI [2,3]
C0279494
UMLS CUI [3,1]
C0233477
UMLS CUI [3,2]
C0282402
UMLS CUI [3,3]
C0205263
UMLS CUI [4,1]
C0349217
UMLS CUI [4,2]
C0026062
UMLS CUI [5]
C1269683
UMLS CUI [6]
C0520675
UMLS CUI [7]
C0025345
UMLS CUI [8,1]
C0011581
UMLS CUI [8,2]
C0544452
UMLS CUI [9,1]
C0282402
UMLS CUI [9,2]
C0949062
2. age 45 to 65
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
3. in good medical health
Description

General health good

Data type

boolean

Alias
UMLS CUI [1]
C1277245
women without past perimenopausal depression -
Description

Depression perimenopausal Lacking

Data type

boolean

Alias
UMLS CUI [1,1]
C1963857
UMLS CUI [1,2]
C0332268
to control for the effects of the hormonal manipulations in this protocol, we will also recruit a group of asymptomatic controls who are either currently on et or were prescribed et previously and with no previous history of perimenopause-related depression or hrt-induced dysphoria. women who participate in this study as the asymptomatic comparison group will meet the following criteria:
Description

Control Group Asymptomatic | Estrogen therapy | Depression perimenopausal | Dysphoria Hormone Therapy Induced

Data type

boolean

Alias
UMLS CUI [1,1]
C0009932
UMLS CUI [1,2]
C0231221
UMLS CUI [2]
C0279494
UMLS CUI [3]
C1963857
UMLS CUI [4,1]
C0233477
UMLS CUI [4,2]
C0279025
UMLS CUI [4,3]
C0205263
1. women who received hormone therapy (ht) with no previous history of perimenopause-related depression or ht-induced dysphoria
Description

Hormone Therapy | Depression perimenopausal | Dysphoria Hormone Therapy Induced

Data type

boolean

Alias
UMLS CUI [1]
C0279025
UMLS CUI [2]
C1963857
UMLS CUI [3,1]
C0233477
UMLS CUI [3,2]
C0279025
UMLS CUI [3,3]
C0205263
2. no current mood or behavioral problems
Description

Mood Disorders | Abnormal behavior

Data type

boolean

Alias
UMLS CUI [1]
C0525045
UMLS CUI [2]
C0233514
3. age 45 to 65
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
4. in good medical health
Description

General health good

Data type

boolean

Alias
UMLS CUI [1]
C1277245
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. past history of severe major depression with suicidal ideation
Description

Severe major depression | Feeling suicidal

Data type

boolean

Alias
UMLS CUI [1]
C3472470
UMLS CUI [2]
C0424000
2. current treatment with antidepressant medications
Description

Antidepressive Agents

Data type

boolean

Alias
UMLS CUI [1]
C0003289
3. history of ischemic cardiac disease, pulmonary embolism, or thrombophlebitis
Description

Myocardial Ischemia | Pulmonary Embolism | Thrombophlebitis

Data type

boolean

Alias
UMLS CUI [1]
C0151744
UMLS CUI [2]
C0034065
UMLS CUI [3]
C0040046
4. renal disease
Description

Kidney Disease

Data type

boolean

Alias
UMLS CUI [1]
C0022658
5. hepatic dysfunction
Description

Liver Dysfunction

Data type

boolean

Alias
UMLS CUI [1]
C0086565
6. women with a history of carcinoma of the breast
Description

Female Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0007104
7. women with a history of uterine cancer, ill-defined pelvic lesions, particularly undiagnosed ovarian enlargement, undiagnosed vaginal bleeding
Description

Uterine Cancer | Lesion Pelvic | Ovarian enlargement Undiagnosed | Vaginal Hemorrhage Undiagnosed

Data type

boolean

Alias
UMLS CUI [1]
C0153567
UMLS CUI [2,1]
C0221198
UMLS CUI [2,2]
C0030797
UMLS CUI [3,1]
C0392039
UMLS CUI [3,2]
C1408353
UMLS CUI [4,1]
C2979982
UMLS CUI [4,2]
C1408353
8. pregnant women
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
9. cerebrovascular disease (stroke)
Description

Cerebrovascular Disorders | Cerebrovascular accident

Data type

boolean

Alias
UMLS CUI [1]
C0007820
UMLS CUI [2]
C0038454
10. recurrent migraine headaches
Description

Migraine Disorders Recurrent

Data type

boolean

Alias
UMLS CUI [1,1]
C0149931
UMLS CUI [1,2]
C2945760
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Similar models

Eligibility Perimenopausal Depression NCT00060736

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Perimenopausal state Evaluated | Menopausal Reproductive Status Evaluated
Item
all subjects for this protocol will be either self-referred in response to newspaper advertisements or referred by their personal physician. the women participating in this protocol will have previously completed the screening protocol # 88-m-0131 and, therefore, will have had the presence or absence of perimenopausal or menopausal reproductive status evaluated and documented.
boolean
C3839366 (UMLS CUI [1,1])
C0220825 (UMLS CUI [1,2])
C1513126 (UMLS CUI [2,1])
C0035150 (UMLS CUI [2,2])
C0220825 (UMLS CUI [2,3])
Depression perimenopausal | Depressive disorder Responsive Estrogen therapy | Dysphoria Hormone replacement therapy Induced | Depressive episode Middle Age | Major Depressive Disorder | Minor depressive disorder | Menstruation Disturbances | Depressive disorder remission | Hormone replacement therapy Perimenopausal symptoms
Item
1. women with a past perimenopause-related depression (within 12 years) and whose depression responded to et will be recruited to participate in this randomized, parallel-design, double-blind, placebo-controlled study. women with histories of either perimenopausal depression that was not responsive to et or hormone replacement therapy-induced dysphoria due to either the estrogen or the progesterone components of their hormone replacement will be excluded. the diagnosis of perimenopause-related depression will be based on a history of a past depressive episode (major or minor depression confirmed by structured clinical interview for dsm-iv (scid) or schedule of affective disorders and schizophrenia-lifetime version (sads-l), respectively) at midlife in association with menstrual cycle irregularity and the history of remission (also confirmed by scid or sads-l) of this depression after et. additionally, all women will report that they were placed on hrt for the treatment of perimenopausal symptoms, including depression.
boolean
C1963857 (UMLS CUI [1])
C0011581 (UMLS CUI [2,1])
C0205342 (UMLS CUI [2,2])
C0279494 (UMLS CUI [2,3])
C0233477 (UMLS CUI [3,1])
C0282402 (UMLS CUI [3,2])
C0205263 (UMLS CUI [3,3])
C0349217 (UMLS CUI [4,1])
C0026062 (UMLS CUI [4,2])
C1269683 (UMLS CUI [5])
C0520675 (UMLS CUI [6])
C0025345 (UMLS CUI [7])
C0011581 (UMLS CUI [8,1])
C0544452 (UMLS CUI [8,2])
C0282402 (UMLS CUI [9,1])
C0949062 (UMLS CUI [9,2])
Age
Item
2. age 45 to 65
boolean
C0001779 (UMLS CUI [1])
General health good
Item
3. in good medical health
boolean
C1277245 (UMLS CUI [1])
Depression perimenopausal Lacking
Item
women without past perimenopausal depression -
boolean
C1963857 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
Control Group Asymptomatic | Estrogen therapy | Depression perimenopausal | Dysphoria Hormone Therapy Induced
Item
to control for the effects of the hormonal manipulations in this protocol, we will also recruit a group of asymptomatic controls who are either currently on et or were prescribed et previously and with no previous history of perimenopause-related depression or hrt-induced dysphoria. women who participate in this study as the asymptomatic comparison group will meet the following criteria:
boolean
C0009932 (UMLS CUI [1,1])
C0231221 (UMLS CUI [1,2])
C0279494 (UMLS CUI [2])
C1963857 (UMLS CUI [3])
C0233477 (UMLS CUI [4,1])
C0279025 (UMLS CUI [4,2])
C0205263 (UMLS CUI [4,3])
Hormone Therapy | Depression perimenopausal | Dysphoria Hormone Therapy Induced
Item
1. women who received hormone therapy (ht) with no previous history of perimenopause-related depression or ht-induced dysphoria
boolean
C0279025 (UMLS CUI [1])
C1963857 (UMLS CUI [2])
C0233477 (UMLS CUI [3,1])
C0279025 (UMLS CUI [3,2])
C0205263 (UMLS CUI [3,3])
Mood Disorders | Abnormal behavior
Item
2. no current mood or behavioral problems
boolean
C0525045 (UMLS CUI [1])
C0233514 (UMLS CUI [2])
Age
Item
3. age 45 to 65
boolean
C0001779 (UMLS CUI [1])
General health good
Item
4. in good medical health
boolean
C1277245 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Severe major depression | Feeling suicidal
Item
1. past history of severe major depression with suicidal ideation
boolean
C3472470 (UMLS CUI [1])
C0424000 (UMLS CUI [2])
Antidepressive Agents
Item
2. current treatment with antidepressant medications
boolean
C0003289 (UMLS CUI [1])
Myocardial Ischemia | Pulmonary Embolism | Thrombophlebitis
Item
3. history of ischemic cardiac disease, pulmonary embolism, or thrombophlebitis
boolean
C0151744 (UMLS CUI [1])
C0034065 (UMLS CUI [2])
C0040046 (UMLS CUI [3])
Kidney Disease
Item
4. renal disease
boolean
C0022658 (UMLS CUI [1])
Liver Dysfunction
Item
5. hepatic dysfunction
boolean
C0086565 (UMLS CUI [1])
Female Breast Carcinoma
Item
6. women with a history of carcinoma of the breast
boolean
C0007104 (UMLS CUI [1])
Uterine Cancer | Lesion Pelvic | Ovarian enlargement Undiagnosed | Vaginal Hemorrhage Undiagnosed
Item
7. women with a history of uterine cancer, ill-defined pelvic lesions, particularly undiagnosed ovarian enlargement, undiagnosed vaginal bleeding
boolean
C0153567 (UMLS CUI [1])
C0221198 (UMLS CUI [2,1])
C0030797 (UMLS CUI [2,2])
C0392039 (UMLS CUI [3,1])
C1408353 (UMLS CUI [3,2])
C2979982 (UMLS CUI [4,1])
C1408353 (UMLS CUI [4,2])
Pregnancy
Item
8. pregnant women
boolean
C0032961 (UMLS CUI [1])
Cerebrovascular Disorders | Cerebrovascular accident
Item
9. cerebrovascular disease (stroke)
boolean
C0007820 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
Migraine Disorders Recurrent
Item
10. recurrent migraine headaches
boolean
C0149931 (UMLS CUI [1,1])
C2945760 (UMLS CUI [1,2])
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