ID

28904

Beskrivning

Effectiveness of Sertraline Alone and Interpersonal Psychotherapy Alone in Treating Women With Postpartum Depression; ODM derived from: https://clinicaltrials.gov/show/NCT00602355

Länk

https://clinicaltrials.gov/show/NCT00602355

Nyckelord

Versioner (2)
  1. 2018-02-14 2018-02-14 -
  2. 2018-02-14 2018-02-14 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

14 februari 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Depression, Postpartum NCT00602355

Engelsk

Eligibility Depression, Postpartum NCT00602355

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
primary dsm-iv diagnosis of major depressive disorder by clinical interview
Beskrivning

Major Depressive Disorder Primary

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1269683
UMLS CUI [1,2]
C0205225
score of greater than 12 on ham-d
Beskrivning

Hamilton rating scale for depression

Datatyp

boolean

Alias
UMLS CUI [1]
C0451203
delivery of an infant within the 12 months prior to study entry
Beskrivning

Delivery

Datatyp

boolean

Alias
UMLS CUI [1]
C0005615
able to speak and read english sufficiently to complete the study procedures
Beskrivning

Able to speak English Language | Able to read English Language | Clinical Trial procedure Completion

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0564215
UMLS CUI [1,2]
C0376245
UMLS CUI [2,1]
C0586740
UMLS CUI [2,2]
C0376245
UMLS CUI [3,1]
C0008976
UMLS CUI [3,2]
C0184661
UMLS CUI [3,3]
C0205197
willing to use effective birth control methods throughout the study
Beskrivning

Contraceptive methods Willing

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C0600109
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
woman whose infant has died prior to study entry
Beskrivning

Gender | Infant Death

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0549159
current or past diagnosis of bipolar disorder, schizophrenia or other psychotic disorder;
Beskrivning

Bipolar Disorder | Schizophrenia | Psychotic Disorders

Datatyp

boolean

Alias
UMLS CUI [1]
C0005586
UMLS CUI [2]
C0036341
UMLS CUI [3]
C0033975
diagnosis of alcohol or drug abuse or dependence (except nicotine) or anorexia in the past year;
Beskrivning

Substance Use Disorders | Substance Dependence | Exception Nicotine | Anorexia

Datatyp

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0038580
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0028040
UMLS CUI [4]
C0003123
psychotic symptoms;
Beskrivning

Psychotic symptom

Datatyp

boolean

Alias
UMLS CUI [1]
C0871189
acute suicidal or homicidal risks;
Beskrivning

At risk for suicide | At risk Homicide

Datatyp

boolean

Alias
UMLS CUI [1]
C0563664
UMLS CUI [2,1]
C1444641
UMLS CUI [2,2]
C0019872
women who have been on an antidepressant for more than 14 days prior to consent, (if less than 14 days and willing to taper off, will be eligible to continue once tapered off);
Beskrivning

Gender | Antidepressive Agents

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0003289
women on daily anxiolytic medication (i.e. benzodiazepine, buspirone) or daily psychoactive herbal preparation (st. john's wort or fish oil) (if willing to discontinue these substances may be eligible once they have been tapered off);
Beskrivning

Gender | Anti-Anxiety Agents | Benzodiazepines | Buspirone | Plant Preparations Psychoactive | Hypericum perforatum | Fish Oil

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0040616
UMLS CUI [3]
C0005064
UMLS CUI [4]
C0006462
UMLS CUI [5,1]
C0949854
UMLS CUI [5,2]
C0682880
UMLS CUI [6]
C0936242
UMLS CUI [7]
C0016157
medications taken prn over the listed dose and frequency (women will still be eligible if they take: lunesta/eszopiclone 3 mg or less, up to 3 nights a week, ambien/zolpidem 5mg or less, ambien cr 6.25 mg or less, up to 3 nights a week, lorazepam or equivalent benzodiazepine dose: 0.5 mg up to 3 nights a week, sonata/zaleplon: 5 mg or less, up to 3 nights a week, rozerem/ramelteon: 8 mg or less, up to 3 nights a week);
Beskrivning

Pharmaceutical Preparations Dosage Frequency | Lunesta | Eszopiclone | Ambien | Zolpidem | Ambien CR | Lorazepam | Benzodiazepine Dosage Equivalent | Sonata | Zaleplon | Rozerem | Ramelteon

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C3476109
UMLS CUI [2]
C1579761
UMLS CUI [3]
C1436328
UMLS CUI [4]
C0487782
UMLS CUI [5]
C0078839
UMLS CUI [6]
C1644791
UMLS CUI [7]
C0024002
UMLS CUI [8,1]
C4048284
UMLS CUI [8,2]
C0178602
UMLS CUI [8,3]
C0205163
UMLS CUI [9]
C0876170
UMLS CUI [10]
C0251504
UMLS CUI [11]
C1621477
UMLS CUI [12]
C1565316
if they take antidepressants prn for insomnia (eg: desyrel/trazodone, elavil/amitriptyline, remeron/mirtazapine;
Beskrivning

Antidepressive Agents Sleeplessness | Desyrel | Trazodone | Elavil | Amitriptyline | Remeron | Mirtazapine

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0003289
UMLS CUI [1,2]
C0917801
UMLS CUI [2]
C0701914
UMLS CUI [3]
C0040805
UMLS CUI [4]
C0087119
UMLS CUI [5]
C0002600
UMLS CUI [6]
C0525726
UMLS CUI [7]
C0049506
ongoing concurrent psychotherapeutic treatment or psychotherapeutic treatment within the last month;
Beskrivning

Psychotherapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0033968
psychiatric symptoms requiring specialized psychiatric treatment;
Beskrivning

Psychiatric symptom Requirement Psychiatric therapeutic procedure Specialized

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0233401
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0204523
UMLS CUI [1,4]
C1704211
significant medical disorder that would make sertraline treatment contra-indicated,
Beskrivning

Disease | Medical contraindication Sertraline

Datatyp

boolean

Alias
UMLS CUI [1]
C0012634
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0074393
previous trial of ipt therapy with a certified ipt therapist or an adequate trial of sertraline (i.e. at least 8 weeks of at least 100 mg daily of sertraline).
Beskrivning

Study Subject Participation Status | Interpersonal psychotherapy | Sertraline Dosage Frequency

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0871787
UMLS CUI [3,1]
C0074393
UMLS CUI [3,2]
C0178602
UMLS CUI [3,3]
C0439603
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Similar models

Eligibility Depression, Postpartum NCT00602355

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Major Depressive Disorder Primary
Item
primary dsm-iv diagnosis of major depressive disorder by clinical interview
boolean
C1269683 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
Hamilton rating scale for depression
Item
score of greater than 12 on ham-d
boolean
C0451203 (UMLS CUI [1])
Delivery
Item
delivery of an infant within the 12 months prior to study entry
boolean
C0005615 (UMLS CUI [1])
Able to speak English Language | Able to read English Language | Clinical Trial procedure Completion
Item
able to speak and read english sufficiently to complete the study procedures
boolean
C0564215 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0586740 (UMLS CUI [2,1])
C0376245 (UMLS CUI [2,2])
C0008976 (UMLS CUI [3,1])
C0184661 (UMLS CUI [3,2])
C0205197 (UMLS CUI [3,3])
Contraceptive methods Willing
Item
willing to use effective birth control methods throughout the study
boolean
C0700589 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Gender | Infant Death
Item
woman whose infant has died prior to study entry
boolean
C0079399 (UMLS CUI [1])
C0549159 (UMLS CUI [2])
Bipolar Disorder | Schizophrenia | Psychotic Disorders
Item
current or past diagnosis of bipolar disorder, schizophrenia or other psychotic disorder;
boolean
C0005586 (UMLS CUI [1])
C0036341 (UMLS CUI [2])
C0033975 (UMLS CUI [3])
Substance Use Disorders | Substance Dependence | Exception Nicotine | Anorexia
Item
diagnosis of alcohol or drug abuse or dependence (except nicotine) or anorexia in the past year;
boolean
C0038586 (UMLS CUI [1])
C0038580 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0028040 (UMLS CUI [3,2])
C0003123 (UMLS CUI [4])
Psychotic symptom
Item
psychotic symptoms;
boolean
C0871189 (UMLS CUI [1])
At risk for suicide | At risk Homicide
Item
acute suicidal or homicidal risks;
boolean
C0563664 (UMLS CUI [1])
C1444641 (UMLS CUI [2,1])
C0019872 (UMLS CUI [2,2])
Gender | Antidepressive Agents
Item
women who have been on an antidepressant for more than 14 days prior to consent, (if less than 14 days and willing to taper off, will be eligible to continue once tapered off);
boolean
C0079399 (UMLS CUI [1])
C0003289 (UMLS CUI [2])
Gender | Anti-Anxiety Agents | Benzodiazepines | Buspirone | Plant Preparations Psychoactive | Hypericum perforatum | Fish Oil
Item
women on daily anxiolytic medication (i.e. benzodiazepine, buspirone) or daily psychoactive herbal preparation (st. john's wort or fish oil) (if willing to discontinue these substances may be eligible once they have been tapered off);
boolean
C0079399 (UMLS CUI [1])
C0040616 (UMLS CUI [2])
C0005064 (UMLS CUI [3])
C0006462 (UMLS CUI [4])
C0949854 (UMLS CUI [5,1])
C0682880 (UMLS CUI [5,2])
C0936242 (UMLS CUI [6])
C0016157 (UMLS CUI [7])
Pharmaceutical Preparations Dosage Frequency | Lunesta | Eszopiclone | Ambien | Zolpidem | Ambien CR | Lorazepam | Benzodiazepine Dosage Equivalent | Sonata | Zaleplon | Rozerem | Ramelteon
Item
medications taken prn over the listed dose and frequency (women will still be eligible if they take: lunesta/eszopiclone 3 mg or less, up to 3 nights a week, ambien/zolpidem 5mg or less, ambien cr 6.25 mg or less, up to 3 nights a week, lorazepam or equivalent benzodiazepine dose: 0.5 mg up to 3 nights a week, sonata/zaleplon: 5 mg or less, up to 3 nights a week, rozerem/ramelteon: 8 mg or less, up to 3 nights a week);
boolean
C0013227 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C3476109 (UMLS CUI [1,3])
C1579761 (UMLS CUI [2])
C1436328 (UMLS CUI [3])
C0487782 (UMLS CUI [4])
C0078839 (UMLS CUI [5])
C1644791 (UMLS CUI [6])
C0024002 (UMLS CUI [7])
C4048284 (UMLS CUI [8,1])
C0178602 (UMLS CUI [8,2])
C0205163 (UMLS CUI [8,3])
C0876170 (UMLS CUI [9])
C0251504 (UMLS CUI [10])
C1621477 (UMLS CUI [11])
C1565316 (UMLS CUI [12])
Antidepressive Agents Sleeplessness | Desyrel | Trazodone | Elavil | Amitriptyline | Remeron | Mirtazapine
Item
if they take antidepressants prn for insomnia (eg: desyrel/trazodone, elavil/amitriptyline, remeron/mirtazapine;
boolean
C0003289 (UMLS CUI [1,1])
C0917801 (UMLS CUI [1,2])
C0701914 (UMLS CUI [2])
C0040805 (UMLS CUI [3])
C0087119 (UMLS CUI [4])
C0002600 (UMLS CUI [5])
C0525726 (UMLS CUI [6])
C0049506 (UMLS CUI [7])
Psychotherapy
Item
ongoing concurrent psychotherapeutic treatment or psychotherapeutic treatment within the last month;
boolean
C0033968 (UMLS CUI [1])
Psychiatric symptom Requirement Psychiatric therapeutic procedure Specialized
Item
psychiatric symptoms requiring specialized psychiatric treatment;
boolean
C0233401 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0204523 (UMLS CUI [1,3])
C1704211 (UMLS CUI [1,4])
Disease | Medical contraindication Sertraline
Item
significant medical disorder that would make sertraline treatment contra-indicated,
boolean
C0012634 (UMLS CUI [1])
C1301624 (UMLS CUI [2,1])
C0074393 (UMLS CUI [2,2])
Study Subject Participation Status | Interpersonal psychotherapy | Sertraline Dosage Frequency
Item
previous trial of ipt therapy with a certified ipt therapist or an adequate trial of sertraline (i.e. at least 8 weeks of at least 100 mg daily of sertraline).
boolean
C2348568 (UMLS CUI [1])
C0871787 (UMLS CUI [2])
C0074393 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0439603 (UMLS CUI [3,3])
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