ID

35709

Description

Efficacy and Safety of Paroxetine Controlled Release for Major Depressive Disorder in Irritable Bowel Syndrome Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01916200

Link

https://clinicaltrials.gov/show/NCT01916200

Keywords

  1. 3/17/19 3/17/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

March 17, 2019

DOI

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License

Creative Commons BY 4.0

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Eligibility Depressive Disorder NCT01916200

Eligibility Depressive Disorder NCT01916200

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. meet the diagnostic for ibs according to rome iii;
Description

Irritable Bowel Syndrome

Data type

boolean

Alias
UMLS CUI [1]
C0022104
2. meet the diagnostic for mdd according to mini;
Description

Major Depressive Disorder

Data type

boolean

Alias
UMLS CUI [1]
C1269683
3. age≥18 and ≤ 65;
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
4. patients or their guardian have the ability to understand and to provide informed consent to the examination, observation, and evaluation; processes specified in this protocol, and have signed the informed consent from based on a full understanding of the trial.
Description

Comprehension Study Protocol | Comprehension Study Protocol Guardian | Informed Consent | Informed Consent Guardian

Data type

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C2348563
UMLS CUI [2,1]
C0162340
UMLS CUI [2,2]
C2348563
UMLS CUI [2,3]
C1274041
UMLS CUI [3]
C0021430
UMLS CUI [4,1]
C0021430
UMLS CUI [4,2]
C1274041
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients were also excluded if they had any medical condition that would contraindicate the use of paroxetine cr [seroxat cr®];
Description

Medical contraindication Paroxetine CR | Medical contraindication Seroxat CR

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0070122
UMLS CUI [1,3]
C1707506
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0678139
UMLS CUI [2,3]
C1707506
2. history of alcohol / drug dependence and schizophrenia; history of serious mental illness;
Description

Substance Dependence | Schizophrenia | Serious mental illness

Data type

boolean

Alias
UMLS CUI [1]
C0038580
UMLS CUI [2]
C0036341
UMLS CUI [3]
C3841614
3. major neurological deficits that interfere with the patient's ability to understand the study procedures and provide a written informed consent;
Description

Neurologic Deficits Major | Interference Comprehension Study Protocol | Neurologic Deficits Major Interfere with Informed Consent

Data type

boolean

Alias
UMLS CUI [1,1]
C0521654
UMLS CUI [1,2]
C0205164
UMLS CUI [2,1]
C0521102
UMLS CUI [2,2]
C0162340
UMLS CUI [2,3]
C2348563
UMLS CUI [3,1]
C0521654
UMLS CUI [3,2]
C0205164
UMLS CUI [3,3]
C0521102
UMLS CUI [3,4]
C0021430
4. patients were also excluded if their current episode of depression had failed to respond to two or more adequate trials of antidepressants, benzodiazepines, or other anxiolytics at a clinically appropriate dose for a minimum of 4 weeks;
Description

Episode of Depressive disorder Unresponsive to Treatment | Therapeutic procedure Quantity | Antidepressive Agents | Benzodiazepines | Anti-Anxiety Agents

Data type

boolean

Alias
UMLS CUI [1,1]
C0332189
UMLS CUI [1,2]
C0011581
UMLS CUI [1,3]
C0205269
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C1265611
UMLS CUI [3]
C0003289
UMLS CUI [4]
C0005064
UMLS CUI [5]
C0040616
5. suicide ideation;
Description

Feeling suicidal

Data type

boolean

Alias
UMLS CUI [1]
C0424000
6. use monoamine oxidase inhibitors (maois), benzodiazepines or other antidepressants within at least 14 days before study begin;
Description

Monoamine Oxidase Inhibitors | Benzodiazepines | Antidepressive Agents

Data type

boolean

Alias
UMLS CUI [1]
C0026457
UMLS CUI [2]
C0005064
UMLS CUI [3]
C0003289
7. other medical and psychological conditions prevent patients from participating in the study or signing informed consent;
Description

Other medical condition Study Subject Participation Status Excluded | Other medical condition Preventing Informed Consent | Mental condition Study Subject Participation Status Excluded | Mental condition Preventing Informed Consent

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C0332196
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C1292733
UMLS CUI [2,3]
C0021430
UMLS CUI [3,1]
C3840291
UMLS CUI [3,2]
C2348568
UMLS CUI [3,3]
C0332196
UMLS CUI [4,1]
C3840291
UMLS CUI [4,2]
C1292733
UMLS CUI [4,3]
C0021430
8. pregnant or lactating females, or anyone who plan to become pregnant during the study period;
Description

Pregnancy | Breast Feeding | Pregnancy, Planned

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
9. those who are known to currently participate a clinical trial;
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
10. those patients with significant organ disease. gi disorders that are infectious;
Description

Organ Disease | Gastrointestinal tract infectious disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0178784
UMLS CUI [1,2]
C0012634
UMLS CUI [2]
C0543767
11. ischemic, radiation-induced, or medication-induced; inflammatory bowel disease (cohn's disease and ulcerative colitis);
Description

Disease Ischemic | Disease Due to Therapeutic radiology procedure | Disease Drug-induced | Inflammatory Bowel Diseases | Crohn Disease | Ulcerative Colitis

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0475224
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C1522449
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C0458082
UMLS CUI [4]
C0021390
UMLS CUI [5]
C0010346
UMLS CUI [6]
C0009324
12. recent gastrointestinal surgery (within 6 months).
Description

Gastrointestinal Surgical Procedure

Data type

boolean

Alias
UMLS CUI [1]
C0524722
13. has received electroconvulsive therapy (ect) or psychotherapy in the 3 months prior to screening.
Description

Electroconvulsive Therapy | Psychotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0013806
UMLS CUI [2]
C0033968
14. presents with clinically significant abnormalities in haematology, clinical chemistry, electrocardiogram (ecg) or physical examination at screening which have not resolved prior to the baseline visit or has clinically significant conditions, which in the opinion of the investigator, will render the patient unsuitable for the study and pose a safety concern or interfere with the accurate safety and efficacy assessments (e.g., severe cardiovascular disease, hepatic or renal failure etc).
Description

Hematology finding abnormal | Clinical Chemistry Tests Abnormal | Electrocardiogram abnormal | Physical examination abnormal | Resolution Lacking | Medical condition Study Subject Participation Status Inappropriate | Medical condition At risk Patient safety | Medical condition Interferes with Safety Assessment | Medical condition Interferes with Evaluation | Cardiovascular Disease Severe | Liver Failure | Kidney Failure

Data type

boolean

Alias
UMLS CUI [1]
C0475182
UMLS CUI [2,1]
C0525044
UMLS CUI [2,2]
C0205161
UMLS CUI [3]
C0522055
UMLS CUI [4]
C0747585
UMLS CUI [5,1]
C1514893
UMLS CUI [5,2]
C0332268
UMLS CUI [6,1]
C3843040
UMLS CUI [6,2]
C2348568
UMLS CUI [6,3]
C1548788
UMLS CUI [7,1]
C3843040
UMLS CUI [7,2]
C1444641
UMLS CUI [7,3]
C1113679
UMLS CUI [8,1]
C3843040
UMLS CUI [8,2]
C0521102
UMLS CUI [8,3]
C0549076
UMLS CUI [9,1]
C3843040
UMLS CUI [9,2]
C0521102
UMLS CUI [9,3]
C0220825
UMLS CUI [10,1]
C0007222
UMLS CUI [10,2]
C0205082
UMLS CUI [11]
C0085605
UMLS CUI [12]
C0035078

Similar models

Eligibility Depressive Disorder NCT01916200

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Irritable Bowel Syndrome
Item
1. meet the diagnostic for ibs according to rome iii;
boolean
C0022104 (UMLS CUI [1])
Major Depressive Disorder
Item
2. meet the diagnostic for mdd according to mini;
boolean
C1269683 (UMLS CUI [1])
Age
Item
3. age≥18 and ≤ 65;
boolean
C0001779 (UMLS CUI [1])
Comprehension Study Protocol | Comprehension Study Protocol Guardian | Informed Consent | Informed Consent Guardian
Item
4. patients or their guardian have the ability to understand and to provide informed consent to the examination, observation, and evaluation; processes specified in this protocol, and have signed the informed consent from based on a full understanding of the trial.
boolean
C0162340 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0162340 (UMLS CUI [2,1])
C2348563 (UMLS CUI [2,2])
C1274041 (UMLS CUI [2,3])
C0021430 (UMLS CUI [3])
C0021430 (UMLS CUI [4,1])
C1274041 (UMLS CUI [4,2])
Item Group
C0680251 (UMLS CUI)
Medical contraindication Paroxetine CR | Medical contraindication Seroxat CR
Item
1. patients were also excluded if they had any medical condition that would contraindicate the use of paroxetine cr [seroxat cr®];
boolean
C1301624 (UMLS CUI [1,1])
C0070122 (UMLS CUI [1,2])
C1707506 (UMLS CUI [1,3])
C1301624 (UMLS CUI [2,1])
C0678139 (UMLS CUI [2,2])
C1707506 (UMLS CUI [2,3])
Substance Dependence | Schizophrenia | Serious mental illness
Item
2. history of alcohol / drug dependence and schizophrenia; history of serious mental illness;
boolean
C0038580 (UMLS CUI [1])
C0036341 (UMLS CUI [2])
C3841614 (UMLS CUI [3])
Neurologic Deficits Major | Interference Comprehension Study Protocol | Neurologic Deficits Major Interfere with Informed Consent
Item
3. major neurological deficits that interfere with the patient's ability to understand the study procedures and provide a written informed consent;
boolean
C0521654 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0521102 (UMLS CUI [2,1])
C0162340 (UMLS CUI [2,2])
C2348563 (UMLS CUI [2,3])
C0521654 (UMLS CUI [3,1])
C0205164 (UMLS CUI [3,2])
C0521102 (UMLS CUI [3,3])
C0021430 (UMLS CUI [3,4])
Episode of Depressive disorder Unresponsive to Treatment | Therapeutic procedure Quantity | Antidepressive Agents | Benzodiazepines | Anti-Anxiety Agents
Item
4. patients were also excluded if their current episode of depression had failed to respond to two or more adequate trials of antidepressants, benzodiazepines, or other anxiolytics at a clinically appropriate dose for a minimum of 4 weeks;
boolean
C0332189 (UMLS CUI [1,1])
C0011581 (UMLS CUI [1,2])
C0205269 (UMLS CUI [1,3])
C0087111 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0003289 (UMLS CUI [3])
C0005064 (UMLS CUI [4])
C0040616 (UMLS CUI [5])
Feeling suicidal
Item
5. suicide ideation;
boolean
C0424000 (UMLS CUI [1])
Monoamine Oxidase Inhibitors | Benzodiazepines | Antidepressive Agents
Item
6. use monoamine oxidase inhibitors (maois), benzodiazepines or other antidepressants within at least 14 days before study begin;
boolean
C0026457 (UMLS CUI [1])
C0005064 (UMLS CUI [2])
C0003289 (UMLS CUI [3])
Other medical condition Study Subject Participation Status Excluded | Other medical condition Preventing Informed Consent | Mental condition Study Subject Participation Status Excluded | Mental condition Preventing Informed Consent
Item
7. other medical and psychological conditions prevent patients from participating in the study or signing informed consent;
boolean
C3843040 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0332196 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C0021430 (UMLS CUI [2,3])
C3840291 (UMLS CUI [3,1])
C2348568 (UMLS CUI [3,2])
C0332196 (UMLS CUI [3,3])
C3840291 (UMLS CUI [4,1])
C1292733 (UMLS CUI [4,2])
C0021430 (UMLS CUI [4,3])
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
8. pregnant or lactating females, or anyone who plan to become pregnant during the study period;
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Study Subject Participation Status
Item
9. those who are known to currently participate a clinical trial;
boolean
C2348568 (UMLS CUI [1])
Organ Disease | Gastrointestinal tract infectious disease
Item
10. those patients with significant organ disease. gi disorders that are infectious;
boolean
C0178784 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0543767 (UMLS CUI [2])
Disease Ischemic | Disease Due to Therapeutic radiology procedure | Disease Drug-induced | Inflammatory Bowel Diseases | Crohn Disease | Ulcerative Colitis
Item
11. ischemic, radiation-induced, or medication-induced; inflammatory bowel disease (cohn's disease and ulcerative colitis);
boolean
C0012634 (UMLS CUI [1,1])
C0475224 (UMLS CUI [1,2])
C0012634 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C1522449 (UMLS CUI [2,3])
C0012634 (UMLS CUI [3,1])
C0458082 (UMLS CUI [3,2])
C0021390 (UMLS CUI [4])
C0010346 (UMLS CUI [5])
C0009324 (UMLS CUI [6])
Gastrointestinal Surgical Procedure
Item
12. recent gastrointestinal surgery (within 6 months).
boolean
C0524722 (UMLS CUI [1])
Electroconvulsive Therapy | Psychotherapy
Item
13. has received electroconvulsive therapy (ect) or psychotherapy in the 3 months prior to screening.
boolean
C0013806 (UMLS CUI [1])
C0033968 (UMLS CUI [2])
Hematology finding abnormal | Clinical Chemistry Tests Abnormal | Electrocardiogram abnormal | Physical examination abnormal | Resolution Lacking | Medical condition Study Subject Participation Status Inappropriate | Medical condition At risk Patient safety | Medical condition Interferes with Safety Assessment | Medical condition Interferes with Evaluation | Cardiovascular Disease Severe | Liver Failure | Kidney Failure
Item
14. presents with clinically significant abnormalities in haematology, clinical chemistry, electrocardiogram (ecg) or physical examination at screening which have not resolved prior to the baseline visit or has clinically significant conditions, which in the opinion of the investigator, will render the patient unsuitable for the study and pose a safety concern or interfere with the accurate safety and efficacy assessments (e.g., severe cardiovascular disease, hepatic or renal failure etc).
boolean
C0475182 (UMLS CUI [1])
C0525044 (UMLS CUI [2,1])
C0205161 (UMLS CUI [2,2])
C0522055 (UMLS CUI [3])
C0747585 (UMLS CUI [4])
C1514893 (UMLS CUI [5,1])
C0332268 (UMLS CUI [5,2])
C3843040 (UMLS CUI [6,1])
C2348568 (UMLS CUI [6,2])
C1548788 (UMLS CUI [6,3])
C3843040 (UMLS CUI [7,1])
C1444641 (UMLS CUI [7,2])
C1113679 (UMLS CUI [7,3])
C3843040 (UMLS CUI [8,1])
C0521102 (UMLS CUI [8,2])
C0549076 (UMLS CUI [8,3])
C3843040 (UMLS CUI [9,1])
C0521102 (UMLS CUI [9,2])
C0220825 (UMLS CUI [9,3])
C0007222 (UMLS CUI [10,1])
C0205082 (UMLS CUI [10,2])
C0085605 (UMLS CUI [11])
C0035078 (UMLS CUI [12])

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