ID

30491

Description

International Study to Predict Optimised Treatment - in Depression; ODM derived from: https://clinicaltrials.gov/show/NCT00693849

Link

https://clinicaltrials.gov/show/NCT00693849

Keywords

Versions (1)
  1. 6/8/18 6/8/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 8, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Major Depressive Disorder NCT00693849

English

Eligibility Major Depressive Disorder NCT00693849

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
meet dsm-iv criteria for primary diagnosis of mdd.
Description

Major Depressive Disorder Principal diagnosis

Data type

boolean

Alias
UMLS CUI [1,1]
C1269683
UMLS CUI [1,2]
C0332137
ham-d17 score of ≥ 16.
Description

Hamilton Depression Rating Scale 17 Item Clinical Classification

Data type

boolean

Alias
UMLS CUI [1]
C3639712
18-65 years age-range
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
subjects with english or dutch literacy and fluency.
Description

Literacy English Language | Literacy Dutch Language | Able to speak fluently English Language | Able to speak fluently Dutch Language

Data type

boolean

Alias
UMLS CUI [1,1]
C0023864
UMLS CUI [1,2]
C0376245
UMLS CUI [2,1]
C0023864
UMLS CUI [2,2]
C0376241
UMLS CUI [3,1]
C0564241
UMLS CUI [3,2]
C0376245
UMLS CUI [4,1]
C0564241
UMLS CUI [4,2]
C0376241
written, informed consent.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
presence of suicidal ideations and/or tendencies (as determined by a score >12 on section c, suicidality, of the mini plus), bipolar i-iii, psychosis, primary eating disorders, post traumatic stress disorder (ptsd), obsessive compulsive disorder (ocd), post-natal depression as well as any axis ii personality disorders as diagnosed using the mini plus or by a health care professional.
Description

Feeling suicidal | Suicidal tendency | Bipolar I disorder | Bipolar II disorder | Psychotic Disorders | Eating Disorders Primary | Post-Traumatic Stress Disorder | Obsessive-Compulsive Disorder | Depression, Postpartum | Personality Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0424000
UMLS CUI [2]
C0235196
UMLS CUI [3]
C0853193
UMLS CUI [4]
C0236788
UMLS CUI [5]
C0033975
UMLS CUI [6,1]
C0013473
UMLS CUI [6,2]
C0205225
UMLS CUI [7]
C0038436
UMLS CUI [8]
C0028768
UMLS CUI [9]
C0221074
UMLS CUI [10]
C0031212
pregnancy and women of child bearing potential who are not taking a medically accepted form of contraception and are at risk of becoming pregnant during the study.
Description

Pregnancy | Childbearing Potential Contraceptive methods Absent | At risk Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C0332197
UMLS CUI [3,1]
C1444641
UMLS CUI [3,2]
C0032961
breastfeeding.
Description

Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0006147
known contra-indication or intolerance to the use of escitalopram, sertraline or venlafaxine xr as defined in the product package insert for each drug (including previous treatment failure at the highest recommended dose).
Description

Medical contraindication Escitalopram | Intolerance to Escitalopram | Medical contraindication Sertraline | Intolerance to Sertraline | Medical contraindication Venlafaxine XR | Intolerance to Venlafaxine XR | Treatment failure High dose

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C1099456
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C1099456
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C0074393
UMLS CUI [4,1]
C1744706
UMLS CUI [4,2]
C0074393
UMLS CUI [5,1]
C1301624
UMLS CUI [5,2]
C0078569
UMLS CUI [5,3]
C1707968
UMLS CUI [6,1]
C1744706
UMLS CUI [6,2]
C0078569
UMLS CUI [6,3]
C1707968
UMLS CUI [7,1]
C0162643
UMLS CUI [7,2]
C0444956
use of any psychological or counselling therapy or antidepressant/cns drug which cannot be washed out prior to participation and eliminated until after week 8 or discontinuation.
Description

Psychological therapies | Psychological counseling | Antidepressive Agents | Central Nervous System Agents

Data type

boolean

Alias
UMLS CUI [1]
C0841584
UMLS CUI [2]
C0474178
UMLS CUI [3]
C0003289
UMLS CUI [4]
C0007680
use of any medication which is known to be contraindicated with escitalopram, sertraline, or venlafaxine xr (refer to the product package insert for each drug).
Description

Pharmaceutical Preparations Contraindicated Escitalopram | Pharmaceutical Preparations Contraindicated Sertraline | Pharmaceutical Preparations Contraindicated Venlafaxine XR

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1444657
UMLS CUI [1,3]
C1099456
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C1444657
UMLS CUI [2,3]
C0074393
UMLS CUI [3,1]
C0013227
UMLS CUI [3,2]
C1444657
UMLS CUI [3,3]
C0078569
UMLS CUI [3,4]
C1707968
known medical condition, disease or neurological disorder which might, in the opinion of investigator/s, interfere with the assessments to be made in the study or put subjects at increased risk when exposed to optimal doses of the drug treatment.
Description

Medical condition Interferes with Assessment | Disease Interferes with Assessment | Nervous system disorder Interferes with Assessment | Medical condition At risk Pharmacotherapy | Disease At risk Pharmacotherapy | Nervous system disorder At risk Pharmacotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C1516048
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C1516048
UMLS CUI [3,1]
C0027765
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C1516048
UMLS CUI [4,1]
C3843040
UMLS CUI [4,2]
C1444641
UMLS CUI [4,3]
C0013216
UMLS CUI [5,1]
C0012634
UMLS CUI [5,2]
C1444641
UMLS CUI [5,3]
C0013216
UMLS CUI [6,1]
C0027765
UMLS CUI [6,2]
C1444641
UMLS CUI [6,3]
C0013216
history of head injury with loss of consciousness for at least 10 minutes.
Description

Craniocerebral Trauma | Unconscious State Duration

Data type

boolean

Alias
UMLS CUI [1]
C0018674
UMLS CUI [2,1]
C0041657
UMLS CUI [2,2]
C0449238
recent/current substance dependence (as defined in section k of the mini plus as per a 6 months period and/or alcoholism) in the past six months.
Description

Substance Dependence | Alcoholic Intoxication, Chronic

Data type

boolean

Alias
UMLS CUI [1]
C0038580
UMLS CUI [2]
C0001973
participation in an investigational study within four months of the baseline visit in which subjects have received an experimental drug/device that could affect the primary end points of this study.
Description

Study Subject Participation Status | Investigational New Drugs Affecting Endpoints | Investigational Medical Device Affecting Endpoints

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0013230
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C2349179
UMLS CUI [3,1]
C2346570
UMLS CUI [3,2]
C0392760
UMLS CUI [3,3]
C2349179
subjects who, in the opinion of the investigator, have a severe impediment to vision, hearing and/or hand movement, which is likely to interfere with their ability to complete the test batteries.
Description

Visual Impairment Severe Interferes with Tests | Hearing impairment Severe Interferes with Tests | Difficulty moving hand Severe Interferes with Tests

Data type

boolean

Alias
UMLS CUI [1,1]
C3665347
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0521102
UMLS CUI [1,4]
C0392366
UMLS CUI [2,1]
C1384666
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C0521102
UMLS CUI [2,4]
C0392366
UMLS CUI [3,1]
C0239827
UMLS CUI [3,2]
C0205082
UMLS CUI [3,3]
C0521102
UMLS CUI [3,4]
C0392366
subjects who, in the opinion of the investigator, are unable and/or unlikely to comprehend and follow the study procedures and instructions.
Description

Protocol Compliance Unable | Protocol Compliance Unlikely

Data type

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C0750558
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Similar models

Eligibility Major Depressive Disorder NCT00693849

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Major Depressive Disorder Principal diagnosis
Item
meet dsm-iv criteria for primary diagnosis of mdd.
boolean
C1269683 (UMLS CUI [1,1])
C0332137 (UMLS CUI [1,2])
Hamilton Depression Rating Scale 17 Item Clinical Classification
Item
ham-d17 score of ≥ 16.
boolean
C3639712 (UMLS CUI [1])
Age
Item
18-65 years age-range
boolean
C0001779 (UMLS CUI [1])
Literacy English Language | Literacy Dutch Language | Able to speak fluently English Language | Able to speak fluently Dutch Language
Item
subjects with english or dutch literacy and fluency.
boolean
C0023864 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0023864 (UMLS CUI [2,1])
C0376241 (UMLS CUI [2,2])
C0564241 (UMLS CUI [3,1])
C0376245 (UMLS CUI [3,2])
C0564241 (UMLS CUI [4,1])
C0376241 (UMLS CUI [4,2])
Informed Consent
Item
written, informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Feeling suicidal | Suicidal tendency | Bipolar I disorder | Bipolar II disorder | Psychotic Disorders | Eating Disorders Primary | Post-Traumatic Stress Disorder | Obsessive-Compulsive Disorder | Depression, Postpartum | Personality Disorders
Item
presence of suicidal ideations and/or tendencies (as determined by a score >12 on section c, suicidality, of the mini plus), bipolar i-iii, psychosis, primary eating disorders, post traumatic stress disorder (ptsd), obsessive compulsive disorder (ocd), post-natal depression as well as any axis ii personality disorders as diagnosed using the mini plus or by a health care professional.
boolean
C0424000 (UMLS CUI [1])
C0235196 (UMLS CUI [2])
C0853193 (UMLS CUI [3])
C0236788 (UMLS CUI [4])
C0033975 (UMLS CUI [5])
C0013473 (UMLS CUI [6,1])
C0205225 (UMLS CUI [6,2])
C0038436 (UMLS CUI [7])
C0028768 (UMLS CUI [8])
C0221074 (UMLS CUI [9])
C0031212 (UMLS CUI [10])
Pregnancy | Childbearing Potential Contraceptive methods Absent | At risk Pregnancy
Item
pregnancy and women of child bearing potential who are not taking a medically accepted form of contraception and are at risk of becoming pregnant during the study.
boolean
C0032961 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C1444641 (UMLS CUI [3,1])
C0032961 (UMLS CUI [3,2])
Breast Feeding
Item
breastfeeding.
boolean
C0006147 (UMLS CUI [1])
Medical contraindication Escitalopram | Intolerance to Escitalopram | Medical contraindication Sertraline | Intolerance to Sertraline | Medical contraindication Venlafaxine XR | Intolerance to Venlafaxine XR | Treatment failure High dose
Item
known contra-indication or intolerance to the use of escitalopram, sertraline or venlafaxine xr as defined in the product package insert for each drug (including previous treatment failure at the highest recommended dose).
boolean
C1301624 (UMLS CUI [1,1])
C1099456 (UMLS CUI [1,2])
C1744706 (UMLS CUI [2,1])
C1099456 (UMLS CUI [2,2])
C1301624 (UMLS CUI [3,1])
C0074393 (UMLS CUI [3,2])
C1744706 (UMLS CUI [4,1])
C0074393 (UMLS CUI [4,2])
C1301624 (UMLS CUI [5,1])
C0078569 (UMLS CUI [5,2])
C1707968 (UMLS CUI [5,3])
C1744706 (UMLS CUI [6,1])
C0078569 (UMLS CUI [6,2])
C1707968 (UMLS CUI [6,3])
C0162643 (UMLS CUI [7,1])
C0444956 (UMLS CUI [7,2])
Psychological therapies | Psychological counseling | Antidepressive Agents | Central Nervous System Agents
Item
use of any psychological or counselling therapy or antidepressant/cns drug which cannot be washed out prior to participation and eliminated until after week 8 or discontinuation.
boolean
C0841584 (UMLS CUI [1])
C0474178 (UMLS CUI [2])
C0003289 (UMLS CUI [3])
C0007680 (UMLS CUI [4])
Pharmaceutical Preparations Contraindicated Escitalopram | Pharmaceutical Preparations Contraindicated Sertraline | Pharmaceutical Preparations Contraindicated Venlafaxine XR
Item
use of any medication which is known to be contraindicated with escitalopram, sertraline, or venlafaxine xr (refer to the product package insert for each drug).
boolean
C0013227 (UMLS CUI [1,1])
C1444657 (UMLS CUI [1,2])
C1099456 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C1444657 (UMLS CUI [2,2])
C0074393 (UMLS CUI [2,3])
C0013227 (UMLS CUI [3,1])
C1444657 (UMLS CUI [3,2])
C0078569 (UMLS CUI [3,3])
C1707968 (UMLS CUI [3,4])
Medical condition Interferes with Assessment | Disease Interferes with Assessment | Nervous system disorder Interferes with Assessment | Medical condition At risk Pharmacotherapy | Disease At risk Pharmacotherapy | Nervous system disorder At risk Pharmacotherapy
Item
known medical condition, disease or neurological disorder which might, in the opinion of investigator/s, interfere with the assessments to be made in the study or put subjects at increased risk when exposed to optimal doses of the drug treatment.
boolean
C3843040 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C1516048 (UMLS CUI [1,3])
C0012634 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C1516048 (UMLS CUI [2,3])
C0027765 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C1516048 (UMLS CUI [3,3])
C3843040 (UMLS CUI [4,1])
C1444641 (UMLS CUI [4,2])
C0013216 (UMLS CUI [4,3])
C0012634 (UMLS CUI [5,1])
C1444641 (UMLS CUI [5,2])
C0013216 (UMLS CUI [5,3])
C0027765 (UMLS CUI [6,1])
C1444641 (UMLS CUI [6,2])
C0013216 (UMLS CUI [6,3])
Craniocerebral Trauma | Unconscious State Duration
Item
history of head injury with loss of consciousness for at least 10 minutes.
boolean
C0018674 (UMLS CUI [1])
C0041657 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
Substance Dependence | Alcoholic Intoxication, Chronic
Item
recent/current substance dependence (as defined in section k of the mini plus as per a 6 months period and/or alcoholism) in the past six months.
boolean
C0038580 (UMLS CUI [1])
C0001973 (UMLS CUI [2])
Study Subject Participation Status | Investigational New Drugs Affecting Endpoints | Investigational Medical Device Affecting Endpoints
Item
participation in an investigational study within four months of the baseline visit in which subjects have received an experimental drug/device that could affect the primary end points of this study.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C2349179 (UMLS CUI [2,3])
C2346570 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C2349179 (UMLS CUI [3,3])
Visual Impairment Severe Interferes with Tests | Hearing impairment Severe Interferes with Tests | Difficulty moving hand Severe Interferes with Tests
Item
subjects who, in the opinion of the investigator, have a severe impediment to vision, hearing and/or hand movement, which is likely to interfere with their ability to complete the test batteries.
boolean
C3665347 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C0392366 (UMLS CUI [1,4])
C1384666 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0521102 (UMLS CUI [2,3])
C0392366 (UMLS CUI [2,4])
C0239827 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0521102 (UMLS CUI [3,3])
C0392366 (UMLS CUI [3,4])
Protocol Compliance Unable | Protocol Compliance Unlikely
Item
subjects who, in the opinion of the investigator, are unable and/or unlikely to comprehend and follow the study procedures and instructions.
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C0750558 (UMLS CUI [2,2])
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