ID

13784

Beschreibung

Investigation of Tibolone and Escitalopram in Perimenopausal Depression; ODM derived from: https://clinicaltrials.gov/show/NCT01368068

Link

https://clinicaltrials.gov/show/NCT01368068

Stichworte

Versionen (2)
  1. 06.03.16 06.03.16 -
  2. 20.09.21 20.09.21 -
Hochgeladen am

6. März 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Perimenopausal Depression NCT01368068

Englisch

Eligibility Perimenopausal Depression NCT01368068

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
females who are currently physically well and between 45 and 55 years of age
Beschreibung

female; age

Datentyp

boolean

Alias
UMLS CUI [1]
C0015780
UMLS CUI [2]
C0001779
current dsm-iv diagnosis of depression disorder
Beschreibung

dsm-iv; depression

Datentyp

boolean

Alias
UMLS CUI [1]
C0220952
UMLS CUI [2]
C0011570
able to give informed consent
Beschreibung

informed consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
perimenopausal as determined by symptom profile on the stages of reproductive aging workshop and gonadal hormonal profile
Beschreibung

perimenopausal

Datentyp

boolean

Alias
UMLS CUI [1]
C3839366
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
known abnormalities in the hypothalamic-pituitary gonadal axis, thyroid dysfunction, central nervous system tumours, active or past history of a venous thromboembolic event, breast pathology, undiagnosed vaginal bleeding or abnormal pap smear results in the previous 2 years.
Beschreibung

Hypothalamic-pituitary-gonadal axis dysfunction; thyroid dysfunction; cns neoplasm; Thromboembolism of vein; breast pathology; vaginal bleeding

Datentyp

boolean

Alias
UMLS CUI [1]
C2711580
UMLS CUI [2]
C0348024
UMLS CUI [3]
C0085136
UMLS CUI [4]
C1997614
UMLS CUI [5]
C3258885
UMLS CUI [6]
C2979982
patients with any significant unstable medical illness such as epilepsy and diabetes or known active cardiac, renal or liver disease; or the presence of illness causing immobilisation.
Beschreibung

epilepsy; diabetes; Heart Diseases; renal disease; Liver diseases

Datentyp

boolean

Alias
UMLS CUI [1]
C0014544
UMLS CUI [2]
C0011847
UMLS CUI [3]
C0018799
UMLS CUI [4]
C0022658
UMLS CUI [5]
C0023895
patients receiving treatment for depression including antidepressant medications, electroconvulsive therapy (ect) / transcranial magnetic stimulation (tms), formal psychotherapy or counselling, within the past 6 months
Beschreibung

antidepressants; electroconvulsive therapy; transcranial magnetic stimulation; psychotherapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0003289
UMLS CUI [2]
C0013806
UMLS CUI [3]
C0436548
UMLS CUI [4]
C0033968
patients experiencing severe melancholia, neurovegetative symptoms or current suicidality necessitating acute hospitalisation or intensive psychiatric treatment.
Beschreibung

melancholia; Suicidality; hospitalisation

Datentyp

boolean

Alias
UMLS CUI [1]
C0025193
UMLS CUI [2]
C3166387
UMLS CUI [3]
C0019993
patients with psychotic symptoms or past history of severe mental illness including schizophrenia, and bipolar disorder.
Beschreibung

psychotic symptoms; schizophrenia; bipolar disorder

Datentyp

boolean

Alias
UMLS CUI [1]
C0871189
UMLS CUI [2]
C0036341
UMLS CUI [3]
C0005586
use of any form of estrogen, progestin or androgen as hormonal therapy, or antiandrogen including tibolone or use of phytoestrogen supplements as powder or tablet
Beschreibung

hormonal therapy tibolone

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C0076660
pregnancy / lactation
Beschreibung

pregnancy; lactating

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
smoking cigarettes and other nicotine products.
Beschreibung

smoking

Datentyp

boolean

Alias
UMLS CUI [1]
C1519386
illicit drug use and more than 3 standard drinks per day
Beschreibung

Substance Use Disorder

Datentyp

boolean

Alias
UMLS CUI [1]
C0038586
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Ähnliche Modelle

Eligibility Perimenopausal Depression NCT01368068

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
female; age
Item
females who are currently physically well and between 45 and 55 years of age
boolean
C0015780 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
dsm-iv; depression
Item
current dsm-iv diagnosis of depression disorder
boolean
C0220952 (UMLS CUI [1])
C0011570 (UMLS CUI [2])
informed consent
Item
able to give informed consent
boolean
C0021430 (UMLS CUI [1])
perimenopausal
Item
perimenopausal as determined by symptom profile on the stages of reproductive aging workshop and gonadal hormonal profile
boolean
C3839366 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Hypothalamic-pituitary-gonadal axis dysfunction; thyroid dysfunction; cns neoplasm; Thromboembolism of vein; breast pathology; vaginal bleeding
Item
known abnormalities in the hypothalamic-pituitary gonadal axis, thyroid dysfunction, central nervous system tumours, active or past history of a venous thromboembolic event, breast pathology, undiagnosed vaginal bleeding or abnormal pap smear results in the previous 2 years.
boolean
C2711580 (UMLS CUI [1])
C0348024 (UMLS CUI [2])
C0085136 (UMLS CUI [3])
C1997614 (UMLS CUI [4])
C3258885 (UMLS CUI [5])
C2979982 (UMLS CUI [6])
epilepsy; diabetes; Heart Diseases; renal disease; Liver diseases
Item
patients with any significant unstable medical illness such as epilepsy and diabetes or known active cardiac, renal or liver disease; or the presence of illness causing immobilisation.
boolean
C0014544 (UMLS CUI [1])
C0011847 (UMLS CUI [2])
C0018799 (UMLS CUI [3])
C0022658 (UMLS CUI [4])
C0023895 (UMLS CUI [5])
antidepressants; electroconvulsive therapy; transcranial magnetic stimulation; psychotherapy
Item
patients receiving treatment for depression including antidepressant medications, electroconvulsive therapy (ect) / transcranial magnetic stimulation (tms), formal psychotherapy or counselling, within the past 6 months
boolean
C0003289 (UMLS CUI [1])
C0013806 (UMLS CUI [2])
C0436548 (UMLS CUI [3])
C0033968 (UMLS CUI [4])
melancholia; Suicidality; hospitalisation
Item
patients experiencing severe melancholia, neurovegetative symptoms or current suicidality necessitating acute hospitalisation or intensive psychiatric treatment.
boolean
C0025193 (UMLS CUI [1])
C3166387 (UMLS CUI [2])
C0019993 (UMLS CUI [3])
psychotic symptoms; schizophrenia; bipolar disorder
Item
patients with psychotic symptoms or past history of severe mental illness including schizophrenia, and bipolar disorder.
boolean
C0871189 (UMLS CUI [1])
C0036341 (UMLS CUI [2])
C0005586 (UMLS CUI [3])
hormonal therapy tibolone
Item
use of any form of estrogen, progestin or androgen as hormonal therapy, or antiandrogen including tibolone or use of phytoestrogen supplements as powder or tablet
boolean
C0279025 (UMLS CUI [1,1])
C0076660 (UMLS CUI [1,2])
pregnancy; lactating
Item
pregnancy / lactation
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
smoking
Item
smoking cigarettes and other nicotine products.
boolean
C1519386 (UMLS CUI [1])
Substance Use Disorder
Item
illicit drug use and more than 3 standard drinks per day
boolean
C0038586 (UMLS CUI [1])
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