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

Link

https://clinicaltrials.gov/show/NCT00566735

Keywords

Versions (1)
  1. 10/17/16 10/17/16 -
Uploaded on

October 17, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Major Depression NCT00566735

English

Eligibility Major Depression NCT00566735

1 forms  
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

Data type

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

Data type

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

Data type

boolean

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

organic mental disorders | Epilepsy

Data type

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

Data type

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

Data type

boolean

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

Systolic Pressure

Data type

boolean

Alias
UMLS CUI [1]
C0871470
heart block
Description

Heart Block

Data type

boolean

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

Sick Sinus Syndrome Pre-existing

Data type

boolean

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

Adrenergic beta-Antagonists chronic

Data type

boolean

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

Cardiac Arrhythmia

Data type

boolean

Alias
UMLS CUI [1]
C0003811
hypotension
Description

Hypotension

Data type

boolean

Alias
UMLS CUI [1]
C0020649
coronary artery disease
Description

Coronary Artery Disease

Data type

boolean

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

Liver Dysfunction | Renal Insufficiency

Data type

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

Data type

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

Data type

boolean

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

Pregnancy

Data type

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

Data type

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

Data type

boolean

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

Eligibility Major Depression NCT00566735

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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