ID

31508

Descripción

Escitalopram in the Treatment of Postpartum Depression; ODM derived from: https://clinicaltrials.gov/show/NCT01527474

Link

https://clinicaltrials.gov/show/NCT01527474

Palabras clave

Versiones (1)
  1. 30/8/18 30/8/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

30 de agosto de 2018

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Postpartum Depression NCT01527474

Inglés

Eligibility Postpartum Depression NCT01527474

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
female between the ages of 19 to 40 years of age
Descripción

Gender | Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
given birth in the last 6 months
Descripción

Birth Recently

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0005615
UMLS CUI [1,2]
C0332185
not currently breastfeeding
Descripción

Breast Feeding Absent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0006147
UMLS CUI [1,2]
C0332197
meet criteria for major depressive disorder as per the diagnostic and statistical manual of mental disorders, 4th edition (dsm-iv tr)
Descripción

Major Depressive Disorder

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1269683
montgomery-asberg depression rating scale (madrs) score greater than or equal to 25 at enrolment
Descripción

Montgomery-Asberg Depression Rating Scale Questionnaire

Tipo de datos

boolean

Alias
UMLS CUI [1]
C4054475
able to read and write english
Descripción

Able to read English Language | Able to write English Language

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0586740
UMLS CUI [1,2]
C0376245
UMLS CUI [2,1]
C0584993
UMLS CUI [2,2]
C0376245
sign written informed consent to participate in the study.
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
have a significant risk of suicide according to the investigator's opinion or presents a score of 5 or greater on item 10 (suicidal thoughts) of of the madrs
Descripción

At risk for suicide | Feeling suicidal MADRS

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0563664
UMLS CUI [2,1]
C0424000
UMLS CUI [2,2]
C4054475
meets dsm-iv-tr criteria for past or current manic or hypomanic episode, past or current psychotic symptoms or disorder, and/or has a history of drug or alcohol abuse/dependence within the last 6 months
Descripción

Manic episode | Hypomanic episode | Psychotic symptom | Psychotic Disorders | Substance Use Disorders | Substance Dependence

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0349208
UMLS CUI [2]
C1396834
UMLS CUI [3]
C0871189
UMLS CUI [4]
C0033975
UMLS CUI [5]
C0038586
UMLS CUI [6]
C0038580
uses the following disallowed recent or concomitant medication within the specified time periods - any antidepressant or any drug used for augmentation of antidepressant action within the last 2 weeks (5 weeks for fluoxetine) prior to baseline, any benzodiazepines or other anxiolytics within the last week prior to baseline, any non-benzodiazepine hypnotics within the last week prior to baseline, oral antipsychotics within 2 weeks or depot antipsychotics within 6 months prior to baseline, serotonergic medicinal products (for example triptans, tryptophan, tramadol) within the last week prior to baseline, psychoactive herbal remedies (for example st. johns wort, kava kava, valerian, gingko biloba) within the last 2 weeks prior to baseline, any other drug with potential psychotropic effects within the last 2 weeks prior to baseline, any anticonvulsant drug within the last 2 weeks prior to baseline, or any investigational product within 3 months prior to baseline
Descripción

Antidepressive Agents | Fluoxetine | Benzodiazepines | Anti-Anxiety Agents | Sedative hypnotics (non-benzodiazepines) | Antipsychotic Agents Oral | Antipsychotic Agents Depot | Serotonin Agents | Triptans | Tryptophan | Tramadol | Herbal medicine Psychoactive | ST. JOHN'S WORT EXTRACT | Kava preparation | Valerian | Ginkgo biloba extract | Psychotropic Drugs | Anticonvulsants | Investigational New Drugs

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0003289
UMLS CUI [2]
C0016365
UMLS CUI [3]
C0005064
UMLS CUI [4]
C0040616
UMLS CUI [5]
C3854290
UMLS CUI [6,1]
C0040615
UMLS CUI [6,2]
C1527415
UMLS CUI [7,1]
C0040615
UMLS CUI [7,2]
C0086129
UMLS CUI [8]
C0242701
UMLS CUI [9]
C1567966
UMLS CUI [10]
C0041249
UMLS CUI [11]
C0040610
UMLS CUI [12,1]
C2240391
UMLS CUI [12,2]
C0682880
UMLS CUI [13]
C0813171
UMLS CUI [14]
C0939882
UMLS CUI [15]
C0795674
UMLS CUI [16]
C0772125
UMLS CUI [17]
C0033978
UMLS CUI [18]
C0003286
UMLS CUI [19]
C0013230
is currently receiving formal cognitive or behavioural therapy, systematic psychotherapy, or plans to initiate such therapy during the study
Descripción

Cognitive Therapy | Behavior Therapy | Psychotherapy systematic | Cognitive Therapy Planned | Behavior Therapy Planned | Psychotherapy systematic Planned

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0009244
UMLS CUI [2]
C0004933
UMLS CUI [3,1]
C0033968
UMLS CUI [3,2]
C0220922
UMLS CUI [4,1]
C0009244
UMLS CUI [4,2]
C1301732
UMLS CUI [5,1]
C0004933
UMLS CUI [5,2]
C1301732
UMLS CUI [6,1]
C0033968
UMLS CUI [6,2]
C0220922
UMLS CUI [6,3]
C1301732
current depressive symptoms of the patient are considered by the investigator to have been resistant to two well-conducted antidepressant treatments of at least 6 weeks duration
Descripción

Depressive Symptoms | Resistant to Antidepressant therapy Quantity

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0086132
UMLS CUI [2,1]
C0332325
UMLS CUI [2,2]
C1096649
UMLS CUI [2,3]
C1265611
has a serious illness or serious sequelae thereof, including liver or renal insufficiency, or a cardiovascular, pulmonary, gastrointestinal, endocrine, neurological (including epilepsy), infectious, neoplastic, or metabolic disturbance (if there is a history of such disease but the condition has been stable for at least one year and is judged by the investigator not to render inclusion unsafe and not to interfere with the patient's participation in the study, the patient may be included.)
Descripción

Illness Serious | Illness Sequelae Serious | Hepatic Insufficiency | Renal Insufficiency | Cardiovascular Disease | Lung disease | Gastrointestinal Disease | Endocrine System Disease | Nervous system disorder | Epilepsy | Communicable Disease | Neoplastic disease | Metabolic Disease

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C0221423
UMLS CUI [2,2]
C0243088
UMLS CUI [2,3]
C0205404
UMLS CUI [3]
C1306571
UMLS CUI [4]
C1565489
UMLS CUI [5]
C0007222
UMLS CUI [6]
C0024115
UMLS CUI [7]
C0017178
UMLS CUI [8]
C0014130
UMLS CUI [9]
C0027765
UMLS CUI [10]
C0014544
UMLS CUI [11]
C0009450
UMLS CUI [12]
C1882062
UMLS CUI [13]
C0025517
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Similar models

Eligibility Postpartum Depression NCT01527474

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age
Item
female between the ages of 19 to 40 years of age
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Birth Recently
Item
given birth in the last 6 months
boolean
C0005615 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
Breast Feeding Absent
Item
not currently breastfeeding
boolean
C0006147 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Major Depressive Disorder
Item
meet criteria for major depressive disorder as per the diagnostic and statistical manual of mental disorders, 4th edition (dsm-iv tr)
boolean
C1269683 (UMLS CUI [1])
Montgomery-Asberg Depression Rating Scale Questionnaire
Item
montgomery-asberg depression rating scale (madrs) score greater than or equal to 25 at enrolment
boolean
C4054475 (UMLS CUI [1])
Able to read English Language | Able to write English Language
Item
able to read and write english
boolean
C0586740 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0584993 (UMLS CUI [2,1])
C0376245 (UMLS CUI [2,2])
Informed Consent
Item
sign written informed consent to participate in the study.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
At risk for suicide | Feeling suicidal MADRS
Item
have a significant risk of suicide according to the investigator's opinion or presents a score of 5 or greater on item 10 (suicidal thoughts) of of the madrs
boolean
C0563664 (UMLS CUI [1])
C0424000 (UMLS CUI [2,1])
C4054475 (UMLS CUI [2,2])
Manic episode | Hypomanic episode | Psychotic symptom | Psychotic Disorders | Substance Use Disorders | Substance Dependence
Item
meets dsm-iv-tr criteria for past or current manic or hypomanic episode, past or current psychotic symptoms or disorder, and/or has a history of drug or alcohol abuse/dependence within the last 6 months
boolean
C0349208 (UMLS CUI [1])
C1396834 (UMLS CUI [2])
C0871189 (UMLS CUI [3])
C0033975 (UMLS CUI [4])
C0038586 (UMLS CUI [5])
C0038580 (UMLS CUI [6])
Antidepressive Agents | Fluoxetine | Benzodiazepines | Anti-Anxiety Agents | Sedative hypnotics (non-benzodiazepines) | Antipsychotic Agents Oral | Antipsychotic Agents Depot | Serotonin Agents | Triptans | Tryptophan | Tramadol | Herbal medicine Psychoactive | ST. JOHN'S WORT EXTRACT | Kava preparation | Valerian | Ginkgo biloba extract | Psychotropic Drugs | Anticonvulsants | Investigational New Drugs
Item
uses the following disallowed recent or concomitant medication within the specified time periods - any antidepressant or any drug used for augmentation of antidepressant action within the last 2 weeks (5 weeks for fluoxetine) prior to baseline, any benzodiazepines or other anxiolytics within the last week prior to baseline, any non-benzodiazepine hypnotics within the last week prior to baseline, oral antipsychotics within 2 weeks or depot antipsychotics within 6 months prior to baseline, serotonergic medicinal products (for example triptans, tryptophan, tramadol) within the last week prior to baseline, psychoactive herbal remedies (for example st. johns wort, kava kava, valerian, gingko biloba) within the last 2 weeks prior to baseline, any other drug with potential psychotropic effects within the last 2 weeks prior to baseline, any anticonvulsant drug within the last 2 weeks prior to baseline, or any investigational product within 3 months prior to baseline
boolean
C0003289 (UMLS CUI [1])
C0016365 (UMLS CUI [2])
C0005064 (UMLS CUI [3])
C0040616 (UMLS CUI [4])
C3854290 (UMLS CUI [5])
C0040615 (UMLS CUI [6,1])
C1527415 (UMLS CUI [6,2])
C0040615 (UMLS CUI [7,1])
C0086129 (UMLS CUI [7,2])
C0242701 (UMLS CUI [8])
C1567966 (UMLS CUI [9])
C0041249 (UMLS CUI [10])
C0040610 (UMLS CUI [11])
C2240391 (UMLS CUI [12,1])
C0682880 (UMLS CUI [12,2])
C0813171 (UMLS CUI [13])
C0939882 (UMLS CUI [14])
C0795674 (UMLS CUI [15])
C0772125 (UMLS CUI [16])
C0033978 (UMLS CUI [17])
C0003286 (UMLS CUI [18])
C0013230 (UMLS CUI [19])
Cognitive Therapy | Behavior Therapy | Psychotherapy systematic | Cognitive Therapy Planned | Behavior Therapy Planned | Psychotherapy systematic Planned
Item
is currently receiving formal cognitive or behavioural therapy, systematic psychotherapy, or plans to initiate such therapy during the study
boolean
C0009244 (UMLS CUI [1])
C0004933 (UMLS CUI [2])
C0033968 (UMLS CUI [3,1])
C0220922 (UMLS CUI [3,2])
C0009244 (UMLS CUI [4,1])
C1301732 (UMLS CUI [4,2])
C0004933 (UMLS CUI [5,1])
C1301732 (UMLS CUI [5,2])
C0033968 (UMLS CUI [6,1])
C0220922 (UMLS CUI [6,2])
C1301732 (UMLS CUI [6,3])
Depressive Symptoms | Resistant to Antidepressant therapy Quantity
Item
current depressive symptoms of the patient are considered by the investigator to have been resistant to two well-conducted antidepressant treatments of at least 6 weeks duration
boolean
C0086132 (UMLS CUI [1])
C0332325 (UMLS CUI [2,1])
C1096649 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
Illness Serious | Illness Sequelae Serious | Hepatic Insufficiency | Renal Insufficiency | Cardiovascular Disease | Lung disease | Gastrointestinal Disease | Endocrine System Disease | Nervous system disorder | Epilepsy | Communicable Disease | Neoplastic disease | Metabolic Disease
Item
has a serious illness or serious sequelae thereof, including liver or renal insufficiency, or a cardiovascular, pulmonary, gastrointestinal, endocrine, neurological (including epilepsy), infectious, neoplastic, or metabolic disturbance (if there is a history of such disease but the condition has been stable for at least one year and is judged by the investigator not to render inclusion unsafe and not to interfere with the patient's participation in the study, the patient may be included.)
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0221423 (UMLS CUI [2,1])
C0243088 (UMLS CUI [2,2])
C0205404 (UMLS CUI [2,3])
C1306571 (UMLS CUI [3])
C1565489 (UMLS CUI [4])
C0007222 (UMLS CUI [5])
C0024115 (UMLS CUI [6])
C0017178 (UMLS CUI [7])
C0014130 (UMLS CUI [8])
C0027765 (UMLS CUI [9])
C0014544 (UMLS CUI [10])
C0009450 (UMLS CUI [11])
C1882062 (UMLS CUI [12])
C0025517 (UMLS CUI [13])
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