ID

20562

Beschrijving

Abilify as an Adjunctive Treatment for Refractory Depression; ODM derived from: https://clinicaltrials.gov/show/NCT00220636

Link

https://clinicaltrials.gov/show/NCT00220636

Trefwoorden

Versies (1)
  1. 03-03-17 03-03-17 -
Geüploaded op

3 maart 2017

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Depressive Disorder, Major NCT00220636

Engels

Eligibility Depressive Disorder, Major NCT00220636

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
male and female outpatients between the ages of 18 and 70.
Beschrijving

Outpatients | Age

Datatype

boolean

Alias
UMLS CUI [1]
C0029921
UMLS CUI [2]
C0001779
patients with a principal diagnostic and statistical manual fourth edition (dsm-iv) diagnosis of major depressive disorder, unipolar, nonpsychotic type
Beschrijving

DEPRESSIVE DISORDER MAJOR WITHOUT PSYCHOTIC FEATURE Unipolar

Datatype

boolean

Alias
UMLS CUI [1,1]
C0743081
UMLS CUI [1,2]
C0443340
patients with a total of 14 or higher on the 17-item hamilton depression scale at baseline
Beschrijving

Hamilton rating scale for depression

Datatype

boolean

Alias
UMLS CUI [1]
C0451203
patients who have had treatment with an ssri at an adequate dose (see table for a minimum of 6 weeks (i.e. 6 wks at the dose defined as adequate in table 2)
Beschrijving

Selective Serotonin Reuptake Inhibitors Dose Adequate

Datatype

boolean

Alias
UMLS CUI [1,1]
C0360105
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205411
patients who agree to use acceptable method of birth control throughout the study
Beschrijving

Contraceptive methods Agree

Datatype

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C3641827
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with any of the following dsm-iv diagnoses: delirium, dementia, amnestic, or other cognitive disorders. bipolar disorder or cyclothymia, schizophrenia, delusional (paranoid) disorders and psychotic disorders not elsewhere classified, severe borderline personality disorder, anorexia nervosa, or bulimia.
Beschrijving

Delirium | Dementia | Amnestic Disorder | Cognition Disorders | Bipolar Disorder | Cyclothymic Disorder | Schizophrenia | Delusional disorder | Paranoia | Psychotic Disorders | Borderline Personality Disorder Severe | Anorexia Nervosa | Bulimia

Datatype

boolean

Alias
UMLS CUI [1]
C0011206
UMLS CUI [2]
C0497327
UMLS CUI [3]
C0002625
UMLS CUI [4]
C0009241
UMLS CUI [5]
C0005586
UMLS CUI [6]
C0010598
UMLS CUI [7]
C0036341
UMLS CUI [8]
C0011251
UMLS CUI [9]
C1456784
UMLS CUI [10]
C0033975
UMLS CUI [11,1]
C0006012
UMLS CUI [11,2]
C0205082
UMLS CUI [12]
C0003125
UMLS CUI [13]
C0006370
patients who, within the past 6 months, met dsm-iv criteria for abuse of or dependence on any drug, including alcohol.
Beschrijving

Substance Use Disorders | Substance Dependence

Datatype

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0038580
patients who are pregnant or nursing women.
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
patients who would pose a serious risk for suicide during the course of the study, as evidenced by one of the following: (a) report of having a specific plan for killing themselves, (b) a score of 3 or higher on the hamilton depression rating scale item
Beschrijving

At risk for suicide | Suicide Plan | Hamilton rating scale for depression

Datatype

boolean

Alias
UMLS CUI [1]
C0563664
UMLS CUI [2,1]
C0038661
UMLS CUI [2,2]
C1301732
UMLS CUI [3]
C0451203
#3 as rated by the treating clinician at week 0, or (c) a suicide attempt within the last 6 months which required medical attention, such as an emergency room visit or which is considered by the treating physician to have been possibly life threatening
Beschrijving

Suicide attempt Required emergency room/doctor visit | Suicide attempt Life Threatening Possible

Datatype

boolean

Alias
UMLS CUI [1,1]
C0038663
UMLS CUI [1,2]
C3846016
UMLS CUI [2,1]
C0038663
UMLS CUI [2,2]
C2826244
UMLS CUI [2,3]
C0332149
patients with unstable medical conditions such as untreated or uncontrolled hyperthyroidism, hypothyroidism, hypertension (defined as blood pressure>150/90), cardiovascular disease, diabetes, hiv (by report of patient).
Beschrijving

Medical condition Unstable | Hyperthyroidism untreated | Hyperthyroidism Uncontrolled | Hypothyroidism untreated | Hypothyroidism Uncontrolled | hypertension untreated | Uncontrolled hypertension | Blood Pressure | Cardiovascular Disease untreated | Cardiovascular Disease Uncontrolled | Diabetes Mellitus untreated | Diabetic - poor control | HIV Infection untreated | HIV Infection Uncontrolled

Datatype

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0443343
UMLS CUI [2,1]
C0020550
UMLS CUI [2,2]
C0332155
UMLS CUI [3,1]
C0020550
UMLS CUI [3,2]
C0205318
UMLS CUI [4]
C2749407
UMLS CUI [5,1]
C0020676
UMLS CUI [5,2]
C0205318
UMLS CUI [6]
C0745134
UMLS CUI [7]
C1868885
UMLS CUI [8]
C0005823
UMLS CUI [9,1]
C0007222
UMLS CUI [9,2]
C0332155
UMLS CUI [10,1]
C0007222
UMLS CUI [10,2]
C0205318
UMLS CUI [11,1]
C0011849
UMLS CUI [11,2]
C0332155
UMLS CUI [12]
C0421258
UMLS CUI [13,1]
C0019693
UMLS CUI [13,2]
C0332155
UMLS CUI [14,1]
C0019693
UMLS CUI [14,2]
C0205318
patients with a history of seizures.
Beschrijving

Seizures

Datatype

boolean

Alias
UMLS CUI [1]
C0036572
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Similar models

Eligibility Depressive Disorder, Major NCT00220636

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Outpatients | Age
Item
male and female outpatients between the ages of 18 and 70.
boolean
C0029921 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
DEPRESSIVE DISORDER MAJOR WITHOUT PSYCHOTIC FEATURE Unipolar
Item
patients with a principal diagnostic and statistical manual fourth edition (dsm-iv) diagnosis of major depressive disorder, unipolar, nonpsychotic type
boolean
C0743081 (UMLS CUI [1,1])
C0443340 (UMLS CUI [1,2])
Hamilton rating scale for depression
Item
patients with a total of 14 or higher on the 17-item hamilton depression scale at baseline
boolean
C0451203 (UMLS CUI [1])
Selective Serotonin Reuptake Inhibitors Dose Adequate
Item
patients who have had treatment with an ssri at an adequate dose (see table for a minimum of 6 weeks (i.e. 6 wks at the dose defined as adequate in table 2)
boolean
C0360105 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205411 (UMLS CUI [1,3])
Contraceptive methods Agree
Item
patients who agree to use acceptable method of birth control throughout the study
boolean
C0700589 (UMLS CUI [1,1])
C3641827 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Delirium | Dementia | Amnestic Disorder | Cognition Disorders | Bipolar Disorder | Cyclothymic Disorder | Schizophrenia | Delusional disorder | Paranoia | Psychotic Disorders | Borderline Personality Disorder Severe | Anorexia Nervosa | Bulimia
Item
patients with any of the following dsm-iv diagnoses: delirium, dementia, amnestic, or other cognitive disorders. bipolar disorder or cyclothymia, schizophrenia, delusional (paranoid) disorders and psychotic disorders not elsewhere classified, severe borderline personality disorder, anorexia nervosa, or bulimia.
boolean
C0011206 (UMLS CUI [1])
C0497327 (UMLS CUI [2])
C0002625 (UMLS CUI [3])
C0009241 (UMLS CUI [4])
C0005586 (UMLS CUI [5])
C0010598 (UMLS CUI [6])
C0036341 (UMLS CUI [7])
C0011251 (UMLS CUI [8])
C1456784 (UMLS CUI [9])
C0033975 (UMLS CUI [10])
C0006012 (UMLS CUI [11,1])
C0205082 (UMLS CUI [11,2])
C0003125 (UMLS CUI [12])
C0006370 (UMLS CUI [13])
Substance Use Disorders | Substance Dependence
Item
patients who, within the past 6 months, met dsm-iv criteria for abuse of or dependence on any drug, including alcohol.
boolean
C0038586 (UMLS CUI [1])
C0038580 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
patients who are pregnant or nursing women.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
At risk for suicide | Suicide Plan | Hamilton rating scale for depression
Item
patients who would pose a serious risk for suicide during the course of the study, as evidenced by one of the following: (a) report of having a specific plan for killing themselves, (b) a score of 3 or higher on the hamilton depression rating scale item
boolean
C0563664 (UMLS CUI [1])
C0038661 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
C0451203 (UMLS CUI [3])
Suicide attempt Required emergency room/doctor visit | Suicide attempt Life Threatening Possible
Item
#3 as rated by the treating clinician at week 0, or (c) a suicide attempt within the last 6 months which required medical attention, such as an emergency room visit or which is considered by the treating physician to have been possibly life threatening
boolean
C0038663 (UMLS CUI [1,1])
C3846016 (UMLS CUI [1,2])
C0038663 (UMLS CUI [2,1])
C2826244 (UMLS CUI [2,2])
C0332149 (UMLS CUI [2,3])
Medical condition Unstable | Hyperthyroidism untreated | Hyperthyroidism Uncontrolled | Hypothyroidism untreated | Hypothyroidism Uncontrolled | hypertension untreated | Uncontrolled hypertension | Blood Pressure | Cardiovascular Disease untreated | Cardiovascular Disease Uncontrolled | Diabetes Mellitus untreated | Diabetic - poor control | HIV Infection untreated | HIV Infection Uncontrolled
Item
patients with unstable medical conditions such as untreated or uncontrolled hyperthyroidism, hypothyroidism, hypertension (defined as blood pressure>150/90), cardiovascular disease, diabetes, hiv (by report of patient).
boolean
C3843040 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0020550 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
C0020550 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C2749407 (UMLS CUI [4])
C0020676 (UMLS CUI [5,1])
C0205318 (UMLS CUI [5,2])
C0745134 (UMLS CUI [6])
C1868885 (UMLS CUI [7])
C0005823 (UMLS CUI [8])
C0007222 (UMLS CUI [9,1])
C0332155 (UMLS CUI [9,2])
C0007222 (UMLS CUI [10,1])
C0205318 (UMLS CUI [10,2])
C0011849 (UMLS CUI [11,1])
C0332155 (UMLS CUI [11,2])
C0421258 (UMLS CUI [12])
C0019693 (UMLS CUI [13,1])
C0332155 (UMLS CUI [13,2])
C0019693 (UMLS CUI [14,1])
C0205318 (UMLS CUI [14,2])
Seizures
Item
patients with a history of seizures.
boolean
C0036572 (UMLS CUI [1])
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