ID

18044

Description

The Use of Galantamine HBr (Reminyl) in Electroconvulsive Therapy: Impact on Mood and Cognitive Functioning; ODM derived from: https://clinicaltrials.gov/show/NCT00566735

Lien

https://clinicaltrials.gov/show/NCT00566735

Mots-clés

  1. 17/10/2016 17/10/2016 -
Téléchargé le

17 octobre 2016

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0

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Eligibility Major Depression NCT00566735

Eligibility Major Depression NCT00566735

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
criteria to enter the study include males and females between the ages of 18-90 (females must be post menopausal) and a dsm-iv diagnosis of major depressive disorder, major depressive disorder with psychotic features, bipolar disorder, depressed type, or schizoaffective disorder, depressed type (19).
Description

Age | Postmenopausal | Major Depressive Disorder | Major Depressive Disorder Associated with psychotic feature | Depression, Bipolar | Schizoaffective disorder, depressive type

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0232970
UMLS CUI [3]
C1269683
UMLS CUI [4,1]
C1269683
UMLS CUI [4,2]
C0332281
UMLS CUI [4,3]
C0743076
UMLS CUI [5]
C0005587
UMLS CUI [6]
C0270497
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
dsm-iv diagnoses of dementia and its subtypes
Description

Dementia | Dementia Subtype

Type de données

boolean

Alias
UMLS CUI [1]
C0497327
UMLS CUI [2,1]
C0497327
UMLS CUI [2,2]
C0449560
substance use disorder (active use within the last 6 months)
Description

Substance Use Disorders

Type de données

boolean

Alias
UMLS CUI [1]
C0038586
organic mental disorders; seizure disorder
Description

organic mental disorders | Epilepsy

Type de données

boolean

Alias
UMLS CUI [1]
C0029227
UMLS CUI [2]
C0014544
unstable physical disorder or physical disorder judged to significantly affect the central nervous system function
Description

physical illness Unstable | physical illness Affecting Significant central nervous system function

Type de données

boolean

Alias
UMLS CUI [1,1]
C0683323
UMLS CUI [1,2]
C0443343
UMLS CUI [2,1]
C0683323
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0750502
UMLS CUI [2,4]
C0683212
a heart rate of <60
Description

heart rate

Type de données

boolean

Alias
UMLS CUI [1]
C0018810
a systolic blood pressure < 90
Description

Systolic Pressure

Type de données

boolean

Alias
UMLS CUI [1]
C0871470
heart block
Description

Heart Block

Type de données

boolean

Alias
UMLS CUI [1]
C0018794
pre-existing sick-sinus
Description

Sick Sinus Syndrome Pre-existing

Type de données

boolean

Alias
UMLS CUI [1,1]
C0037052
UMLS CUI [1,2]
C2347662
chronic treatment with beta blockers
Description

Adrenergic beta-Antagonists chronic

Type de données

boolean

Alias
UMLS CUI [1,1]
C0001645
UMLS CUI [1,2]
C0205191
any cardiac arrythmia
Description

Cardiac Arrhythmia

Type de données

boolean

Alias
UMLS CUI [1]
C0003811
hypotension
Description

Hypotension

Type de données

boolean

Alias
UMLS CUI [1]
C0020649
coronary artery disease
Description

Coronary Artery Disease

Type de données

boolean

Alias
UMLS CUI [1]
C1956346
liver and renal function impairment
Description

Liver Dysfunction | Renal Insufficiency

Type de données

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2]
C1565489
urge incontinence, colitis crohn's disease, gi motility disorders, asthma and copd
Description

Urge Incontinence | Crohn's disease of large bowel | Gastrointestinal motility disorder | Asthma | Chronic Obstructive Airway Disease

Type de données

boolean

Alias
UMLS CUI [1]
C0150045
UMLS CUI [2]
C0156147
UMLS CUI [3]
C0854121
UMLS CUI [4]
C0004096
UMLS CUI [5]
C0024117
treatment with anti-cholinergic and cholinomimetic medications; and
Description

Anticholinergic Agents | Cholinomimetic Drugs

Type de données

boolean

Alias
UMLS CUI [1]
C0242896
UMLS CUI [2]
C0871682
female patients who are pregnant.
Description

Pregnancy

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
additionally, women subjects must be postmenopausal, surgically sterile, or using prescription oral contraceptives (e.g. estrogen-progestin combinations) , contraceptive implants (e.g. norplanttm, depoproveratm ), or transdermally delivered contraceptives (ortho evratm) before entry and throughout the study; and have a negative serum b-hcg pregnancy test at screening.
Description

Postmenopausal state | Female Sterilization | Oral Contraceptives Prescription | Estrogen Progestin Replacement Therapy | Contraceptive implant | Norplant | Depo-Provera | Transdermal contraception | Ortho Evra | Serum pregnancy test (B-HCG) Negative

Type de données

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2]
C0015787
UMLS CUI [3,1]
C0009905
UMLS CUI [3,2]
C0033080
UMLS CUI [4]
C1136072
UMLS CUI [5]
C1657106
UMLS CUI [6]
C1145675
UMLS CUI [7]
C0699700
UMLS CUI [8]
C1168146
UMLS CUI [9]
C1614506
UMLS CUI [10,1]
C0430060
UMLS CUI [10,2]
C1513916
note: abstinence and the use of double barrier contraceptive methods are not acceptable in this study.
Description

Sexual Abstinence | Contraception, Barrier Double

Type de données

boolean

Alias
UMLS CUI [1]
C0036899
UMLS CUI [2,1]
C0004764
UMLS CUI [2,2]
C0205173

Similar models

Eligibility Major Depression NCT00566735

Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Age | Postmenopausal | Major Depressive Disorder | Major Depressive Disorder Associated with psychotic feature | Depression, Bipolar | Schizoaffective disorder, depressive type
Item
criteria to enter the study include males and females between the ages of 18-90 (females must be post menopausal) and a dsm-iv diagnosis of major depressive disorder, major depressive disorder with psychotic features, bipolar disorder, depressed type, or schizoaffective disorder, depressed type (19).
boolean
C0001779 (UMLS CUI [1])
C0232970 (UMLS CUI [2])
C1269683 (UMLS CUI [3])
C1269683 (UMLS CUI [4,1])
C0332281 (UMLS CUI [4,2])
C0743076 (UMLS CUI [4,3])
C0005587 (UMLS CUI [5])
C0270497 (UMLS CUI [6])
Item Group
C0680251 (UMLS CUI)
Dementia | Dementia Subtype
Item
dsm-iv diagnoses of dementia and its subtypes
boolean
C0497327 (UMLS CUI [1])
C0497327 (UMLS CUI [2,1])
C0449560 (UMLS CUI [2,2])
Substance Use Disorders
Item
substance use disorder (active use within the last 6 months)
boolean
C0038586 (UMLS CUI [1])
organic mental disorders | Epilepsy
Item
organic mental disorders; seizure disorder
boolean
C0029227 (UMLS CUI [1])
C0014544 (UMLS CUI [2])
physical illness Unstable | physical illness Affecting Significant central nervous system function
Item
unstable physical disorder or physical disorder judged to significantly affect the central nervous system function
boolean
C0683323 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0683323 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0750502 (UMLS CUI [2,3])
C0683212 (UMLS CUI [2,4])
heart rate
Item
a heart rate of <60
boolean
C0018810 (UMLS CUI [1])
Systolic Pressure
Item
a systolic blood pressure < 90
boolean
C0871470 (UMLS CUI [1])
Heart Block
Item
heart block
boolean
C0018794 (UMLS CUI [1])
Sick Sinus Syndrome Pre-existing
Item
pre-existing sick-sinus
boolean
C0037052 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
Adrenergic beta-Antagonists chronic
Item
chronic treatment with beta blockers
boolean
C0001645 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
Cardiac Arrhythmia
Item
any cardiac arrythmia
boolean
C0003811 (UMLS CUI [1])
Hypotension
Item
hypotension
boolean
C0020649 (UMLS CUI [1])
Coronary Artery Disease
Item
coronary artery disease
boolean
C1956346 (UMLS CUI [1])
Liver Dysfunction | Renal Insufficiency
Item
liver and renal function impairment
boolean
C0086565 (UMLS CUI [1])
C1565489 (UMLS CUI [2])
Urge Incontinence | Crohn's disease of large bowel | Gastrointestinal motility disorder | Asthma | Chronic Obstructive Airway Disease
Item
urge incontinence, colitis crohn's disease, gi motility disorders, asthma and copd
boolean
C0150045 (UMLS CUI [1])
C0156147 (UMLS CUI [2])
C0854121 (UMLS CUI [3])
C0004096 (UMLS CUI [4])
C0024117 (UMLS CUI [5])
Anticholinergic Agents | Cholinomimetic Drugs
Item
treatment with anti-cholinergic and cholinomimetic medications; and
boolean
C0242896 (UMLS CUI [1])
C0871682 (UMLS CUI [2])
Pregnancy
Item
female patients who are pregnant.
boolean
C0032961 (UMLS CUI [1])
Postmenopausal state | Female Sterilization | Oral Contraceptives Prescription | Estrogen Progestin Replacement Therapy | Contraceptive implant | Norplant | Depo-Provera | Transdermal contraception | Ortho Evra | Serum pregnancy test (B-HCG) Negative
Item
additionally, women subjects must be postmenopausal, surgically sterile, or using prescription oral contraceptives (e.g. estrogen-progestin combinations) , contraceptive implants (e.g. norplanttm, depoproveratm ), or transdermally delivered contraceptives (ortho evratm) before entry and throughout the study; and have a negative serum b-hcg pregnancy test at screening.
boolean
C0232970 (UMLS CUI [1])
C0015787 (UMLS CUI [2])
C0009905 (UMLS CUI [3,1])
C0033080 (UMLS CUI [3,2])
C1136072 (UMLS CUI [4])
C1657106 (UMLS CUI [5])
C1145675 (UMLS CUI [6])
C0699700 (UMLS CUI [7])
C1168146 (UMLS CUI [8])
C1614506 (UMLS CUI [9])
C0430060 (UMLS CUI [10,1])
C1513916 (UMLS CUI [10,2])
Sexual Abstinence | Contraception, Barrier Double
Item
note: abstinence and the use of double barrier contraceptive methods are not acceptable in this study.
boolean
C0036899 (UMLS CUI [1])
C0004764 (UMLS CUI [2,1])
C0205173 (UMLS CUI [2,2])

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