ID

28828

Beskrivning

Safety and Antidepressant Effects of Rellidep in Major Depressive Disorder; ODM derived from: https://clinicaltrials.gov/show/NCT00446719

Länk

https://clinicaltrials.gov/show/NCT00446719

Nyckelord

Versioner (1)
  1. 2018-02-06 2018-02-06 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

6 februari 2018

DOI

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Creative Commons BY 4.0
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Eligibility Depression NCT00446719

Engelsk

Eligibility Depression NCT00446719

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT00446719
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
signed written informed consent obtained.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
males/females 20-65 years of age who require a new or a new change in their medication treatment for diagnosed major depression.
Beskrivning

Age | Patient need for Pharmacotherapy New | Patient need for Pharmacotherapy Change New | Major Depressive Disorder

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0686904
UMLS CUI [2,2]
C0013216
UMLS CUI [2,3]
C0205314
UMLS CUI [3,1]
C0686904
UMLS CUI [3,2]
C0013216
UMLS CUI [3,3]
C0392747
UMLS CUI [3,4]
C0205314
UMLS CUI [4]
C1269683
a clinical diagnosis fulfilling dsm-ivtr criteria for major depressive disorder, single episode or recurrent.
Beskrivning

Major Depressive Disorder | Single major depressive episode | Recurrent major depressive episodes

Datatyp

boolean

Alias
UMLS CUI [1]
C1269683
UMLS CUI [2]
C0024517
UMLS CUI [3]
C0154409
17-item hamilton depression rating scale (hamd 17-item) total score at baseline of 18 or higher
Beskrivning

Hamilton Depression Rating Scale 17 Item Questionnaire

Datatyp

boolean

Alias
UMLS CUI [1]
C3639712
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
clinical diagnosis of depression other than dsm-ivtr major depressive disorder (single episode/recurrent, e.g. chronic depression and/or refractory depression are excluded).
Beskrivning

Depressive disorder | Exception Major Depressive Disorder | Exception Single major depressive episode | Exception Recurrent major depressive episodes | Chronic depression | Depressive Disorder, Treatment-Resistant

Datatyp

boolean

Alias
UMLS CUI [1]
C0011581
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1269683
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0024517
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0154409
UMLS CUI [5]
C0581391
UMLS CUI [6]
C2063866
judged to be at significant risk for suicide or having a history suggesting significant current potential for self harm.
Beskrivning

At risk for suicide | Potential Self-harm

Datatyp

boolean

Alias
UMLS CUI [1]
C0563664
UMLS CUI [2,1]
C3245505
UMLS CUI [2,2]
C0424366
antidepressant medication (other than the index antidepressant).
Beskrivning

Antidepressive Agents Other

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0003289
UMLS CUI [1,2]
C0205394
women who are pregnant or breast-feeding or intending to become pregnant in the next 12 months.
Beskrivning

Pregnancy | Breast Feeding | Pregnancy, Planned

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
clinically significant organ system diseases, e.g. cardiovascular, hepatic, renal, endocrine, gastrointestinal, metabolic, or other systemic diseases.
Beskrivning

Organ system Disease | Cardiovascular Diseases | Liver diseases | Kidney Diseases | Endocrine System Diseases | Gastrointestinal Diseases | Metabolic Diseases | Systemic disease

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0460002
UMLS CUI [1,2]
C0012634
UMLS CUI [2]
C0007222
UMLS CUI [3]
C0023895
UMLS CUI [4]
C0022658
UMLS CUI [5]
C0014130
UMLS CUI [6]
C0017178
UMLS CUI [7]
C0025517
UMLS CUI [8]
C0442893
course of electroconvulsive therapy (ect) during the observational period.
Beskrivning

Electroconvulsive Therapy During Observation

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013806
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C1964257
suffer from a major neurological condition (i.e., parkinson's disease, huntington's disease), cerebrovascular disease (i.e., stroke), metabolic conditions (i.e., vitamin b12 deficiency), autoimmune conditions (i.e., systematic lupus erythematosus), viral or other infections (i.e., hepatitis, mononucleosis, human immunodeficiency), and cancer.
Beskrivning

Nervous system disorder Major | Parkinson Disease | Huntington Disease | Cerebrovascular Disorders | Cerebrovascular accident | Metabolic Diseases | Vitamin B 12 Deficiency | Autoimmune Diseases | Lupus Erythematosus, Systemic | Virus Diseases | Communicable Diseases | Hepatitis | Mononucleosis | HIV Infection | Malignant Neoplasms

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0027765
UMLS CUI [1,2]
C0205164
UMLS CUI [2]
C0030567
UMLS CUI [3]
C0020179
UMLS CUI [4]
C0007820
UMLS CUI [5]
C0038454
UMLS CUI [6]
C0025517
UMLS CUI [7]
C0042847
UMLS CUI [8]
C0004364
UMLS CUI [9]
C0024141
UMLS CUI [10]
C0042769
UMLS CUI [11]
C0009450
UMLS CUI [12]
C0019158
UMLS CUI [13]
C0021345
UMLS CUI [14]
C0019693
UMLS CUI [15]
C0006826
current diagnosis of schizophrenia or other psychotic disorders (including schizophreniform disorder, schizoaffective disorder, delusional disorder, brief psychotic disorders, psychotic disorder due to general medical condition, substance induced psychotic, psychotic disorder not otherwise specified) as defined in the dsm-iv.
Beskrivning

Schizophrenia | Psychotic Disorders | Schizophreniform Disorders | Schizoaffective Disorder | Delusional disorder | Psychosis, Brief Reactive | Psychotic disorder due to a general medical condition | Psychoses, Substance-Induced | Psychotic Disorders Not Otherwise Specified

Datatyp

boolean

Alias
UMLS CUI [1]
C0036341
UMLS CUI [2]
C0033975
UMLS CUI [3]
C0036358
UMLS CUI [4]
C0036337
UMLS CUI [5]
C0011251
UMLS CUI [6]
C0033958
UMLS CUI [7]
C0748076
UMLS CUI [8]
C0033941
UMLS CUI [9,1]
C0033975
UMLS CUI [9,2]
C1518425
(sub) clinical hypo/hyper thyroidism (e.g. elevated tsh).
Beskrivning

Hypothyroidism | Hyperthyroidism | Elevated TSH

Datatyp

boolean

Alias
UMLS CUI [1]
C0020676
UMLS CUI [2]
C0020550
UMLS CUI [3]
C1855743
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Similar models

Eligibility Depression NCT00446719

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT00446719
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
signed written informed consent obtained.
boolean
C0021430 (UMLS CUI [1])
Age | Patient need for Pharmacotherapy New | Patient need for Pharmacotherapy Change New | Major Depressive Disorder
Item
males/females 20-65 years of age who require a new or a new change in their medication treatment for diagnosed major depression.
boolean
C0001779 (UMLS CUI [1])
C0686904 (UMLS CUI [2,1])
C0013216 (UMLS CUI [2,2])
C0205314 (UMLS CUI [2,3])
C0686904 (UMLS CUI [3,1])
C0013216 (UMLS CUI [3,2])
C0392747 (UMLS CUI [3,3])
C0205314 (UMLS CUI [3,4])
C1269683 (UMLS CUI [4])
Major Depressive Disorder | Single major depressive episode | Recurrent major depressive episodes
Item
a clinical diagnosis fulfilling dsm-ivtr criteria for major depressive disorder, single episode or recurrent.
boolean
C1269683 (UMLS CUI [1])
C0024517 (UMLS CUI [2])
C0154409 (UMLS CUI [3])
Hamilton Depression Rating Scale 17 Item Questionnaire
Item
17-item hamilton depression rating scale (hamd 17-item) total score at baseline of 18 or higher
boolean
C3639712 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Depressive disorder | Exception Major Depressive Disorder | Exception Single major depressive episode | Exception Recurrent major depressive episodes | Chronic depression | Depressive Disorder, Treatment-Resistant
Item
clinical diagnosis of depression other than dsm-ivtr major depressive disorder (single episode/recurrent, e.g. chronic depression and/or refractory depression are excluded).
boolean
C0011581 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1269683 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0024517 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0154409 (UMLS CUI [4,2])
C0581391 (UMLS CUI [5])
C2063866 (UMLS CUI [6])
At risk for suicide | Potential Self-harm
Item
judged to be at significant risk for suicide or having a history suggesting significant current potential for self harm.
boolean
C0563664 (UMLS CUI [1])
C3245505 (UMLS CUI [2,1])
C0424366 (UMLS CUI [2,2])
Antidepressive Agents Other
Item
antidepressant medication (other than the index antidepressant).
boolean
C0003289 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
women who are pregnant or breast-feeding or intending to become pregnant in the next 12 months.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Organ system Disease | Cardiovascular Diseases | Liver diseases | Kidney Diseases | Endocrine System Diseases | Gastrointestinal Diseases | Metabolic Diseases | Systemic disease
Item
clinically significant organ system diseases, e.g. cardiovascular, hepatic, renal, endocrine, gastrointestinal, metabolic, or other systemic diseases.
boolean
C0460002 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0007222 (UMLS CUI [2])
C0023895 (UMLS CUI [3])
C0022658 (UMLS CUI [4])
C0014130 (UMLS CUI [5])
C0017178 (UMLS CUI [6])
C0025517 (UMLS CUI [7])
C0442893 (UMLS CUI [8])
Electroconvulsive Therapy During Observation
Item
course of electroconvulsive therapy (ect) during the observational period.
boolean
C0013806 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C1964257 (UMLS CUI [1,3])
Nervous system disorder Major | Parkinson Disease | Huntington Disease | Cerebrovascular Disorders | Cerebrovascular accident | Metabolic Diseases | Vitamin B 12 Deficiency | Autoimmune Diseases | Lupus Erythematosus, Systemic | Virus Diseases | Communicable Diseases | Hepatitis | Mononucleosis | HIV Infection | Malignant Neoplasms
Item
suffer from a major neurological condition (i.e., parkinson's disease, huntington's disease), cerebrovascular disease (i.e., stroke), metabolic conditions (i.e., vitamin b12 deficiency), autoimmune conditions (i.e., systematic lupus erythematosus), viral or other infections (i.e., hepatitis, mononucleosis, human immunodeficiency), and cancer.
boolean
C0027765 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0030567 (UMLS CUI [2])
C0020179 (UMLS CUI [3])
C0007820 (UMLS CUI [4])
C0038454 (UMLS CUI [5])
C0025517 (UMLS CUI [6])
C0042847 (UMLS CUI [7])
C0004364 (UMLS CUI [8])
C0024141 (UMLS CUI [9])
C0042769 (UMLS CUI [10])
C0009450 (UMLS CUI [11])
C0019158 (UMLS CUI [12])
C0021345 (UMLS CUI [13])
C0019693 (UMLS CUI [14])
C0006826 (UMLS CUI [15])
Schizophrenia | Psychotic Disorders | Schizophreniform Disorders | Schizoaffective Disorder | Delusional disorder | Psychosis, Brief Reactive | Psychotic disorder due to a general medical condition | Psychoses, Substance-Induced | Psychotic Disorders Not Otherwise Specified
Item
current diagnosis of schizophrenia or other psychotic disorders (including schizophreniform disorder, schizoaffective disorder, delusional disorder, brief psychotic disorders, psychotic disorder due to general medical condition, substance induced psychotic, psychotic disorder not otherwise specified) as defined in the dsm-iv.
boolean
C0036341 (UMLS CUI [1])
C0033975 (UMLS CUI [2])
C0036358 (UMLS CUI [3])
C0036337 (UMLS CUI [4])
C0011251 (UMLS CUI [5])
C0033958 (UMLS CUI [6])
C0748076 (UMLS CUI [7])
C0033941 (UMLS CUI [8])
C0033975 (UMLS CUI [9,1])
C1518425 (UMLS CUI [9,2])
Hypothyroidism | Hyperthyroidism | Elevated TSH
Item
(sub) clinical hypo/hyper thyroidism (e.g. elevated tsh).
boolean
C0020676 (UMLS CUI [1])
C0020550 (UMLS CUI [2])
C1855743 (UMLS CUI [3])
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