ID

18912

Beschreibung

Clinical Trial of Estrogen for Postpartum Depression; ODM derived from: https://clinicaltrials.gov/show/NCT00059228

Link

https://clinicaltrials.gov/show/NCT00059228

Stichworte

Versionen (1)
  1. 24.11.16 24.11.16 -
Hochgeladen am

24. November 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Postpartum Depression NCT00059228

Englisch

Eligibility Postpartum Depression NCT00059228

1 Formulare  
Criteria
Beschreibung

Criteria

subjects for this study will meet the following criteria:
Beschreibung

criteria Fulfill

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
1. a history of at least two weeks with postpartum-related mood disturbances of moderate severity, and self-report of the onset of depression within three months of a normal vaginal delivery or uncomplicated caesarean section;
Beschreibung

Postpartum mood disturbance Moderate Disease length | Depressive disorder Onset Period Normal vaginal delivery | Depressive disorder Onset Period Cesarean section Uncomplicated

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2909480
UMLS CUI [1,2]
C0205081
UMLS CUI [1,3]
C0872146
UMLS CUI [2,1]
C0011581
UMLS CUI [2,2]
C0332162
UMLS CUI [2,3]
C1948053
UMLS CUI [2,4]
C0269694
UMLS CUI [3,1]
C0011581
UMLS CUI [3,2]
C0332162
UMLS CUI [3,3]
C1948053
UMLS CUI [3,4]
C0007876
UMLS CUI [3,5]
C0443334
2. a current episode of minor (meeting 3-4 criterion symptoms) or major depression (of moderate severity or less on the scid severity scale and not meeting dsm-iv criteria symptom 9 [suicidal ideation]) as determined by the administration of the minor depression module of the sads-l and the structured clinical interview for dsm-iv. additionally, to ensure that subjects meet a minimum threshold for severity of depression, subjects will have scores greater than or equal to 10 on either the beck depression inventory (bdi) or the center for epidemiologic studies - depression (ces-d) scale during at least three of the six clinic visits during the two week screening phase, as well as a 17 item hamilton depression score greater than or equal to 10. subjects will be excluded if they meet any of the following criteria: major depression of greater than moderate severity (including postpartum psychosis). dsm-iv criteria #9 (suicidal ideation), or anyone requiring immediate treatment after clinical assessment.
Beschreibung

Minor depressive disorder Episode of | Moderate major depression, single episode | Mild major depression, single episode | Feeling suicidal | Beck depression inventory | Center for Epidemiologic Studies Depression Scale | Hamilton rating scale for depression | Severe major depression | Severe postnatal psychosis | Immediate treatment claim Post Assessment Clinical

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0520675
UMLS CUI [1,2]
C0332189
UMLS CUI [2]
C0154404
UMLS CUI [3]
C0154403
UMLS CUI [4]
C0424000
UMLS CUI [5]
C0451022
UMLS CUI [6]
C2699160
UMLS CUI [7]
C0451203
UMLS CUI [8]
C3472470
UMLS CUI [9]
C0342073
UMLS CUI [10,1]
C0583047
UMLS CUI [10,2]
C0687676
UMLS CUI [10,3]
C1516048
UMLS CUI [10,4]
C0205210
3. not greater than six months post delivery;
Beschreibung

Period Post Delivery

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1948053
UMLS CUI [1,2]
C0687676
UMLS CUI [1,3]
C0011209
4. age 20 to 45;
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
5.) in good medical health, and not taking any medication or dietary and herbal supplements on a regular basis (with the exception of multivitamins or calcium supplements).
Beschreibung

General health good | Pharmaceutical Preparations Regular | Dietary Supplements Regular | Herbal supplement Regular | Multivitamin preparation | CALCIUM SUPPLEMENTS

Datentyp

boolean

Alias
UMLS CUI [1]
C1277245
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0205272
UMLS CUI [3,1]
C0242295
UMLS CUI [3,2]
C0205272
UMLS CUI [4,1]
C1504473
UMLS CUI [4,2]
C0205272
UMLS CUI [5]
C0301532
UMLS CUI [6]
C3540037
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
the following conditions will constitute contraindications to treatment and will preclude a subject s participation in this protocol:
Beschreibung

Condition Causing Medical contraindication Therapeutic procedure | Study Subject Participation Status Exclusion

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0678227
UMLS CUI [1,3]
C1301624
UMLS CUI [1,4]
C0087111
UMLS CUI [2,1]
C2348568
UMLS CUI [2,2]
C2828389
1) severe major depression with any of the following:
Beschreibung

Severe major depression

Datentyp

boolean

Alias
UMLS CUI [1]
C3472470
1. positive (threshold) response to scid major depression section item # 9, suicidal ideation;
Beschreibung

Feeling suicidal Response Threshold Positive

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0424000
UMLS CUI [1,2]
C1704632
UMLS CUI [1,3]
C0449864
UMLS CUI [1,4]
C1514241
2. anyone requiring immediate treatment after clinical assessment;
Beschreibung

Immediate treatment claim Post Assessment Clinical

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0583047
UMLS CUI [1,2]
C0687676
UMLS CUI [1,3]
C1516048
UMLS CUI [1,4]
C0205210
3. severity ratings greater than moderate on the scid iv interview (including postpartum psychosis);
Beschreibung

Severity rating | Severe postnatal psychosis

Datentyp

boolean

Alias
UMLS CUI [1]
C1830455
UMLS CUI [2]
C0342073
2) current treatment with antidepressant medications
Beschreibung

Antidepressive Agents

Datentyp

boolean

Alias
UMLS CUI [1]
C0003289
3) history of psychiatric illness during the two years before the reported onset of the current episode of depression or a history of either mania (dsm-iv criteria) or postpartum psychosis at any time in the past.
Beschreibung

Mental disorder Before Onset of Depressive episode | Mania | Postpartum psychosis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C0332162
UMLS CUI [1,4]
C0349217
UMLS CUI [2]
C0338831
UMLS CUI [3]
C0520678
4) history of ischemic cardiac disease, pulmonary embolism, retinal thrombosis, or thrombophlebitis; any subject with risk factors for thrombo-embolic phenomena including cigarette smokers (greater than 10 cigarettes per day), varicose veins, patients with prolonged periods of immobilization (including prolonged travel), and active heart disease.
Beschreibung

Myocardial Ischemia | Pulmonary Embolism | Retinal thrombosis | Thrombophlebitis | Thromboembolism risk factors | Cigarette smoker Number of cigarettes per day | Varicosity | Immobilisation prolonged | travel Prolonged | Heart Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0151744
UMLS CUI [2]
C0034065
UMLS CUI [3]
C1579873
UMLS CUI [4]
C0040046
UMLS CUI [5,1]
C0040038
UMLS CUI [5,2]
C0035648
UMLS CUI [6,1]
C0337667
UMLS CUI [6,2]
C3694146
UMLS CUI [7]
C0042345
UMLS CUI [8]
C0919574
UMLS CUI [9,1]
C0040802
UMLS CUI [9,2]
C0439590
UMLS CUI [10]
C0018799
5) renal disease, asthma
Beschreibung

Kidney Disease | Asthma

Datentyp

boolean

Alias
UMLS CUI [1]
C0022658
UMLS CUI [2]
C0004096
6) hepatic dysfunction
Beschreibung

Liver Dysfunction

Datentyp

boolean

Alias
UMLS CUI [1]
C0086565
7) women with a history of carcinoma of the breast, or women with a family history of the following: premenopausal breast cancer or bilateral breast cancer in a first degree relative; multiple family members (greater than three relatives) with postmenopausal breast cancer
Beschreibung

Breast Carcinoma | Premenopausal breast cancer First Degree Relative | bilateral breast cancer First Degree Relative | Breast Carcinoma Postmenopausal Family members Quantity

Datentyp

boolean

Alias
UMLS CUI [1]
C0678222
UMLS CUI [2,1]
C0741682
UMLS CUI [2,2]
C1517194
UMLS CUI [3,1]
C0281267
UMLS CUI [3,2]
C1517194
UMLS CUI [4,1]
C0678222
UMLS CUI [4,2]
C0232970
UMLS CUI [4,3]
C0086282
UMLS CUI [4,4]
C1265611
8) women with a history of uterine cancer, endometriosis, ill-defined pelvic lesions, particularly undiagnosed ovarian enlargement, undiagnosed vaginal bleeding
Beschreibung

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

Datentyp

boolean

Alias
UMLS CUI [1]
C0153567
UMLS CUI [2]
C0014175
UMLS CUI [3,1]
C0221198
UMLS CUI [3,2]
C0030797
UMLS CUI [4,1]
C0392039
UMLS CUI [4,2]
C1408353
UMLS CUI [5,1]
C2979982
UMLS CUI [5,2]
C1408353
9) patients with a known hypersensitivity of estradiol, transdermal skin patches, or medroxyprogesterone acetate
Beschreibung

Estradiol allergy | Hypersensitivity Transdermal Patch | Hypersensitivity medroxyprogesterone acetate

Datentyp

boolean

Alias
UMLS CUI [1]
C0571688
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0991556
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0065864
10) pregnant women
Beschreibung

Pregnancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
11) porphyria
Beschreibung

Porphyria

Datentyp

boolean

Alias
UMLS CUI [1]
C3463940
12) diabetes mellitus
Beschreibung

Diabetes Mellitus

Datentyp

boolean

Alias
UMLS CUI [1]
C0011849
13) cholecystitis or pancreatitis
Beschreibung

Cholecystitis | Pancreatitis

Datentyp

boolean

Alias
UMLS CUI [1]
C0008325
UMLS CUI [2]
C0030305
14) history of cerebrovascular disease (stroke), epilepsy, hypertension, hypercalcemia
Beschreibung

Cerebrovascular Disorders | Cerebrovascular accident | Epilepsy | Hypertensive disease | Hypercalcemia

Datentyp

boolean

Alias
UMLS CUI [1]
C0007820
UMLS CUI [2]
C0038454
UMLS CUI [3]
C0014544
UMLS CUI [4]
C0020538
UMLS CUI [5]
C0020437
15) recurrent migraine headaches
Beschreibung

Migraine Disorders Recurrent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0149931
UMLS CUI [1,2]
C2945760
16) malignant melanoma
Beschreibung

melanoma

Datentyp

boolean

Alias
UMLS CUI [1]
C0025202
17) history of familial hyperlipoproteinemia
Beschreibung

Familial hyperlipoproteinemia

Datentyp

boolean

Alias
UMLS CUI [1]
C0700623
18) prior hormonal therapy for the treatment of postpartum-related mood or physical symptoms within the last six months
Beschreibung

Prior Hormone Therapy Postpartum mood disturbance | physical symptom

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1514460
UMLS CUI [1,2]
C2909480
UMLS CUI [2]
C0679309
19) history of psychiatric illness during the two years prior to the reported onset of the current episode of depression
Beschreibung

Mental disorder Before Onset of Depressive episode

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C0332162
UMLS CUI [1,4]
C0349217
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Ähnliche Modelle

Eligibility Postpartum Depression NCT00059228

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
criteria Fulfill
Item
subjects for this study will meet the following criteria:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Postpartum mood disturbance Moderate Disease length | Depressive disorder Onset Period Normal vaginal delivery | Depressive disorder Onset Period Cesarean section Uncomplicated
Item
1. a history of at least two weeks with postpartum-related mood disturbances of moderate severity, and self-report of the onset of depression within three months of a normal vaginal delivery or uncomplicated caesarean section;
boolean
C2909480 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C0872146 (UMLS CUI [1,3])
C0011581 (UMLS CUI [2,1])
C0332162 (UMLS CUI [2,2])
C1948053 (UMLS CUI [2,3])
C0269694 (UMLS CUI [2,4])
C0011581 (UMLS CUI [3,1])
C0332162 (UMLS CUI [3,2])
C1948053 (UMLS CUI [3,3])
C0007876 (UMLS CUI [3,4])
C0443334 (UMLS CUI [3,5])
Minor depressive disorder Episode of | Moderate major depression, single episode | Mild major depression, single episode | Feeling suicidal | Beck depression inventory | Center for Epidemiologic Studies Depression Scale | Hamilton rating scale for depression | Severe major depression | Severe postnatal psychosis | Immediate treatment claim Post Assessment Clinical
Item
2. a current episode of minor (meeting 3-4 criterion symptoms) or major depression (of moderate severity or less on the scid severity scale and not meeting dsm-iv criteria symptom 9 [suicidal ideation]) as determined by the administration of the minor depression module of the sads-l and the structured clinical interview for dsm-iv. additionally, to ensure that subjects meet a minimum threshold for severity of depression, subjects will have scores greater than or equal to 10 on either the beck depression inventory (bdi) or the center for epidemiologic studies - depression (ces-d) scale during at least three of the six clinic visits during the two week screening phase, as well as a 17 item hamilton depression score greater than or equal to 10. subjects will be excluded if they meet any of the following criteria: major depression of greater than moderate severity (including postpartum psychosis). dsm-iv criteria #9 (suicidal ideation), or anyone requiring immediate treatment after clinical assessment.
boolean
C0520675 (UMLS CUI [1,1])
C0332189 (UMLS CUI [1,2])
C0154404 (UMLS CUI [2])
C0154403 (UMLS CUI [3])
C0424000 (UMLS CUI [4])
C0451022 (UMLS CUI [5])
C2699160 (UMLS CUI [6])
C0451203 (UMLS CUI [7])
C3472470 (UMLS CUI [8])
C0342073 (UMLS CUI [9])
C0583047 (UMLS CUI [10,1])
C0687676 (UMLS CUI [10,2])
C1516048 (UMLS CUI [10,3])
C0205210 (UMLS CUI [10,4])
Period Post Delivery
Item
3. not greater than six months post delivery;
boolean
C1948053 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
C0011209 (UMLS CUI [1,3])
Age
Item
4. age 20 to 45;
boolean
C0001779 (UMLS CUI [1])
General health good | Pharmaceutical Preparations Regular | Dietary Supplements Regular | Herbal supplement Regular | Multivitamin preparation | CALCIUM SUPPLEMENTS
Item
5.) in good medical health, and not taking any medication or dietary and herbal supplements on a regular basis (with the exception of multivitamins or calcium supplements).
boolean
C1277245 (UMLS CUI [1])
C0013227 (UMLS CUI [2,1])
C0205272 (UMLS CUI [2,2])
C0242295 (UMLS CUI [3,1])
C0205272 (UMLS CUI [3,2])
C1504473 (UMLS CUI [4,1])
C0205272 (UMLS CUI [4,2])
C0301532 (UMLS CUI [5])
C3540037 (UMLS CUI [6])
Item Group
C0680251 (UMLS CUI)
Condition Causing Medical contraindication Therapeutic procedure | Study Subject Participation Status Exclusion
Item
the following conditions will constitute contraindications to treatment and will preclude a subject s participation in this protocol:
boolean
C0348080 (UMLS CUI [1,1])
C0678227 (UMLS CUI [1,2])
C1301624 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,4])
C2348568 (UMLS CUI [2,1])
C2828389 (UMLS CUI [2,2])
Severe major depression
Item
1) severe major depression with any of the following:
boolean
C3472470 (UMLS CUI [1])
Feeling suicidal Response Threshold Positive
Item
1. positive (threshold) response to scid major depression section item # 9, suicidal ideation;
boolean
C0424000 (UMLS CUI [1,1])
C1704632 (UMLS CUI [1,2])
C0449864 (UMLS CUI [1,3])
C1514241 (UMLS CUI [1,4])
Immediate treatment claim Post Assessment Clinical
Item
2. anyone requiring immediate treatment after clinical assessment;
boolean
C0583047 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
C1516048 (UMLS CUI [1,3])
C0205210 (UMLS CUI [1,4])
Severity rating | Severe postnatal psychosis
Item
3. severity ratings greater than moderate on the scid iv interview (including postpartum psychosis);
boolean
C1830455 (UMLS CUI [1])
C0342073 (UMLS CUI [2])
Antidepressive Agents
Item
2) current treatment with antidepressant medications
boolean
C0003289 (UMLS CUI [1])
Mental disorder Before Onset of Depressive episode | Mania | Postpartum psychosis
Item
3) history of psychiatric illness during the two years before the reported onset of the current episode of depression or a history of either mania (dsm-iv criteria) or postpartum psychosis at any time in the past.
boolean
C0004936 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C0332162 (UMLS CUI [1,3])
C0349217 (UMLS CUI [1,4])
C0338831 (UMLS CUI [2])
C0520678 (UMLS CUI [3])
Myocardial Ischemia | Pulmonary Embolism | Retinal thrombosis | Thrombophlebitis | Thromboembolism risk factors | Cigarette smoker Number of cigarettes per day | Varicosity | Immobilisation prolonged | travel Prolonged | Heart Disease
Item
4) history of ischemic cardiac disease, pulmonary embolism, retinal thrombosis, or thrombophlebitis; any subject with risk factors for thrombo-embolic phenomena including cigarette smokers (greater than 10 cigarettes per day), varicose veins, patients with prolonged periods of immobilization (including prolonged travel), and active heart disease.
boolean
C0151744 (UMLS CUI [1])
C0034065 (UMLS CUI [2])
C1579873 (UMLS CUI [3])
C0040046 (UMLS CUI [4])
C0040038 (UMLS CUI [5,1])
C0035648 (UMLS CUI [5,2])
C0337667 (UMLS CUI [6,1])
C3694146 (UMLS CUI [6,2])
C0042345 (UMLS CUI [7])
C0919574 (UMLS CUI [8])
C0040802 (UMLS CUI [9,1])
C0439590 (UMLS CUI [9,2])
C0018799 (UMLS CUI [10])
Kidney Disease | Asthma
Item
5) renal disease, asthma
boolean
C0022658 (UMLS CUI [1])
C0004096 (UMLS CUI [2])
Liver Dysfunction
Item
6) hepatic dysfunction
boolean
C0086565 (UMLS CUI [1])
Breast Carcinoma | Premenopausal breast cancer First Degree Relative | bilateral breast cancer First Degree Relative | Breast Carcinoma Postmenopausal Family members Quantity
Item
7) women with a history of carcinoma of the breast, or women with a family history of the following: premenopausal breast cancer or bilateral breast cancer in a first degree relative; multiple family members (greater than three relatives) with postmenopausal breast cancer
boolean
C0678222 (UMLS CUI [1])
C0741682 (UMLS CUI [2,1])
C1517194 (UMLS CUI [2,2])
C0281267 (UMLS CUI [3,1])
C1517194 (UMLS CUI [3,2])
C0678222 (UMLS CUI [4,1])
C0232970 (UMLS CUI [4,2])
C0086282 (UMLS CUI [4,3])
C1265611 (UMLS CUI [4,4])
Uterine Cancer | Endometriosis | Lesion Pelvic | Ovarian enlargement Undiagnosed | Vaginal Hemorrhage Undiagnosed
Item
8) women with a history of uterine cancer, endometriosis, ill-defined pelvic lesions, particularly undiagnosed ovarian enlargement, undiagnosed vaginal bleeding
boolean
C0153567 (UMLS CUI [1])
C0014175 (UMLS CUI [2])
C0221198 (UMLS CUI [3,1])
C0030797 (UMLS CUI [3,2])
C0392039 (UMLS CUI [4,1])
C1408353 (UMLS CUI [4,2])
C2979982 (UMLS CUI [5,1])
C1408353 (UMLS CUI [5,2])
Estradiol allergy | Hypersensitivity Transdermal Patch | Hypersensitivity medroxyprogesterone acetate
Item
9) patients with a known hypersensitivity of estradiol, transdermal skin patches, or medroxyprogesterone acetate
boolean
C0571688 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C0991556 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0065864 (UMLS CUI [3,2])
Pregnancy
Item
10) pregnant women
boolean
C0032961 (UMLS CUI [1])
Porphyria
Item
11) porphyria
boolean
C3463940 (UMLS CUI [1])
Diabetes Mellitus
Item
12) diabetes mellitus
boolean
C0011849 (UMLS CUI [1])
Cholecystitis | Pancreatitis
Item
13) cholecystitis or pancreatitis
boolean
C0008325 (UMLS CUI [1])
C0030305 (UMLS CUI [2])
Cerebrovascular Disorders | Cerebrovascular accident | Epilepsy | Hypertensive disease | Hypercalcemia
Item
14) history of cerebrovascular disease (stroke), epilepsy, hypertension, hypercalcemia
boolean
C0007820 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C0014544 (UMLS CUI [3])
C0020538 (UMLS CUI [4])
C0020437 (UMLS CUI [5])
Migraine Disorders Recurrent
Item
15) recurrent migraine headaches
boolean
C0149931 (UMLS CUI [1,1])
C2945760 (UMLS CUI [1,2])
melanoma
Item
16) malignant melanoma
boolean
C0025202 (UMLS CUI [1])
Familial hyperlipoproteinemia
Item
17) history of familial hyperlipoproteinemia
boolean
C0700623 (UMLS CUI [1])
Prior Hormone Therapy Postpartum mood disturbance | physical symptom
Item
18) prior hormonal therapy for the treatment of postpartum-related mood or physical symptoms within the last six months
boolean
C1514460 (UMLS CUI [1,1])
C2909480 (UMLS CUI [1,2])
C0679309 (UMLS CUI [2])
Mental disorder Before Onset of Depressive episode
Item
19) history of psychiatric illness during the two years prior to the reported onset of the current episode of depression
boolean
C0004936 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C0332162 (UMLS CUI [1,3])
C0349217 (UMLS CUI [1,4])
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