ID

13343

Beschrijving

Prozac Treatment of Major Depression: Discontinuation Study; ODM derived from: https://clinicaltrials.gov/show/NCT00427128

Link

https://clinicaltrials.gov/show/NCT00427128

Trefwoorden

  1. 07-02-16 07-02-16 -
Geüploaded op

7 februari 2016

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Major Depression NCT00427128

Eligibility Major Depression NCT00427128

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. men and women ages 18-65
Beschrijving

gender, age

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
2. meets criteria for dsm iv major depression
Beschrijving

major depression dsm iv

Datatype

boolean

Alias
UMLS CUI [1]
C1269683
3. signs informed consent and able to comply with study
Beschrijving

informed consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. pregnant women and women of child-bearing potential who are not using a medically accepted means of contraception.
Beschrijving

pregnant women, childbearing potential, contraceptive methods

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C3831118
UMLS CUI [3]
C0700589
2. women taking oral contraceptives, the initiation of which was temporally associated with the onset of depression; women who are breast-feeding.
Beschrijving

oral contraceptives, breast feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0700589
UMLS CUI [2]
C0006147
3. patients with serious suicidal risk, including any patient who became suicidal with previous discontinuation of an antidepressant.
Beschrijving

suicidal risk

Datatype

boolean

Alias
UMLS CUI [1]
C0438696
4. patients with a history of seizure disorder.
Beschrijving

seizure disorder

Datatype

boolean

Alias
UMLS CUI [1]
C0014544
5. patients with unstable physical disorders (cardiovascular, hepatic, renal, respiratory, endocrine, neurologic, or hematologic) or any physical disorder judged to significantly affect cns function.
Beschrijving

unstable physical disorders or any physical disorder affecting cns function

Datatype

boolean

Alias
UMLS CUI [1]
C0009488
6. patients meeting criteria for the following dsm-iv diagnoses: organic mental disorders; substance use disorders, including alcohol, active within the last 6 months; schizophrenia; delusional disorder; psychotic disorders; bipolar disorder; antisocial personality disorder; or presence of psychotic features
Beschrijving

psychiatric comorbidities

Datatype

boolean

Alias
UMLS CUI [1]
C0349095
UMLS CUI [2]
C0038586
UMLS CUI [3]
C0036341
UMLS CUI [4]
C0011251
UMLS CUI [5]
C0033975
UMLS CUI [6]
C0005586
UMLS CUI [7]
C0003431
UMLS CUI [8]
C0459435
7. patients with a history of non-response to an adequate trial of a selective serotonin reuptake inhibitor in a past or current depressive episode, defined as a four-week trial of a minimum of 40mg/day of fluoxetine or paroxetine, or 100mg/day of sertraline.
Beschrijving

response to treatment with ssri

Datatype

boolean

Alias
UMLS CUI [1,1]
C0360105
UMLS CUI [1,2]
C0521982
8. concurrent use of exclusionary drugs
Beschrijving

medication other

Datatype

boolean

Alias
UMLS CUI [1]
C0013227
9. clinical or laboratory evidence of hypothyroidism without adequate stable replacement (eg, low total t4 or elevated tsh by a high sensitivity method).
Beschrijving

hypothyroidism

Datatype

boolean

Alias
UMLS CUI [1]
C0020676

Similar models

Eligibility Major Depression NCT00427128

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
gender, age
Item
1. men and women ages 18-65
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
major depression dsm iv
Item
2. meets criteria for dsm iv major depression
boolean
C1269683 (UMLS CUI [1])
informed consent
Item
3. signs informed consent and able to comply with study
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
pregnant women, childbearing potential, contraceptive methods
Item
1. pregnant women and women of child-bearing potential who are not using a medically accepted means of contraception.
boolean
C0032961 (UMLS CUI [1])
C3831118 (UMLS CUI [2])
C0700589 (UMLS CUI [3])
oral contraceptives, breast feeding
Item
2. women taking oral contraceptives, the initiation of which was temporally associated with the onset of depression; women who are breast-feeding.
boolean
C0700589 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
suicidal risk
Item
3. patients with serious suicidal risk, including any patient who became suicidal with previous discontinuation of an antidepressant.
boolean
C0438696 (UMLS CUI [1])
seizure disorder
Item
4. patients with a history of seizure disorder.
boolean
C0014544 (UMLS CUI [1])
unstable physical disorders or any physical disorder affecting cns function
Item
5. patients with unstable physical disorders (cardiovascular, hepatic, renal, respiratory, endocrine, neurologic, or hematologic) or any physical disorder judged to significantly affect cns function.
boolean
C0009488 (UMLS CUI [1])
psychiatric comorbidities
Item
6. patients meeting criteria for the following dsm-iv diagnoses: organic mental disorders; substance use disorders, including alcohol, active within the last 6 months; schizophrenia; delusional disorder; psychotic disorders; bipolar disorder; antisocial personality disorder; or presence of psychotic features
boolean
C0349095 (UMLS CUI [1])
C0038586 (UMLS CUI [2])
C0036341 (UMLS CUI [3])
C0011251 (UMLS CUI [4])
C0033975 (UMLS CUI [5])
C0005586 (UMLS CUI [6])
C0003431 (UMLS CUI [7])
C0459435 (UMLS CUI [8])
response to treatment with ssri
Item
7. patients with a history of non-response to an adequate trial of a selective serotonin reuptake inhibitor in a past or current depressive episode, defined as a four-week trial of a minimum of 40mg/day of fluoxetine or paroxetine, or 100mg/day of sertraline.
boolean
C0360105 (UMLS CUI [1,1])
C0521982 (UMLS CUI [1,2])
medication other
Item
8. concurrent use of exclusionary drugs
boolean
C0013227 (UMLS CUI [1])
hypothyroidism
Item
9. clinical or laboratory evidence of hypothyroidism without adequate stable replacement (eg, low total t4 or elevated tsh by a high sensitivity method).
boolean
C0020676 (UMLS CUI [1])

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