ID

36351

Beschrijving

A Phase II Study of PDC-1421 Capsule to Evaluate the Safety and Efficacy in Patients With Major Depressive Disorder; ODM derived from: https://clinicaltrials.gov/show/NCT02395978

Link

https://clinicaltrials.gov/show/NCT02395978

Trefwoorden

Versies (1)
  1. 06-05-19 06-05-19 -
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See clinicaltrials.gov

Geüploaded op

6 mei 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Major Depressive Disorder NCT02395978

Engels

Eligibility Major Depressive Disorder NCT02395978

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. outpatients aged 20-65 years
Beschrijving

Outpatients | Age

Datatype

boolean

Alias
UMLS CUI [1]
C0029921
UMLS CUI [2]
C0001779
2. subjects must be able to understand and willing to sign informed consent
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
3. female subjects of child-bearing potential must test negative to pregnancy and use appropriate birth control method from the beginning of study to the 15 days later after ending of study
Beschrijving

Childbearing Potential Pregnancy test negative | Childbearing Potential Contraceptive methods

Datatype

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
4. met criteria for mdd without psychotic features as defined by the diagnostic and statistical manual of mental disorders, fourth edition text revision® (dsm-iv-tr) and confirmed by use of the mini international neuropsychiatric interview (mini).
Beschrijving

DEPRESSIVE DISORDER MAJOR WITHOUT PSYCHOTIC FEATURE

Datatype

boolean

Alias
UMLS CUI [1]
C0743081
5. 17-item ham-d (hamilton rating scale for depression) total score ≧20 and cgi (clinical global impression) total score ≧4
Beschrijving

Hamilton Depression Rating Scale 17 Item Clinical Classification | Clinical global impression scale

Datatype

boolean

Alias
UMLS CUI [1]
C3639712
UMLS CUI [2]
C3639708
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. have a current or previous major psychiatric disorders which be defined to be per the dsm-iv-tr, including obsessive-compulsive disorder, posttraumatic stress disorder, bipolar i or ii, manic or hypomanic episode, schizophrenia, major axis ii disorders which might compromise the study, and major depression with psychotic symptoms, mental retardation.
Beschrijving

Mental disorders Major compromise Clinical Trial | Obsessive-Compulsive Disorder | Post-Traumatic Stress Disorder | Bipolar I disorder | Bipolar II disorder | Manic episode | Hypomanic episode | Schizophrenia | Axis II diagnosis Major | Major depression with psychotic features | Mental Retardation

Datatype

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0205164
UMLS CUI [1,3]
C2945640
UMLS CUI [1,4]
C0008976
UMLS CUI [2]
C0028768
UMLS CUI [3]
C0038436
UMLS CUI [4]
C0853193
UMLS CUI [5]
C0236788
UMLS CUI [6]
C0349208
UMLS CUI [7]
C1396834
UMLS CUI [8]
C0036341
UMLS CUI [9,1]
C0270288
UMLS CUI [9,2]
C0205164
UMLS CUI [10]
C4518519
UMLS CUI [11]
C0025362
2. use of any treatment for mdd in the last 2 weeks before visit 1 (4 weeks for fluoxetine).
Beschrijving

Therapeutic procedure Major Depressive Disorder | Fluoxetine

Datatype

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C1269683
UMLS CUI [2]
C0016365
3. use of psychoactive drugs within the last 2 weeks before visit 1 other than that subjects had insomnia who need the treatment as determined by the investigator.
Beschrijving

Psychotropic Drugs | Exception Relationship Insomnia

Datatype

boolean

Alias
UMLS CUI [1]
C0033978
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0439849
UMLS CUI [2,3]
C0917801
4. subjects who were non-responsive to two or more courses of antidepressant medications given an adequate dosage for symptom treatment within four weeks, or by the judgment of the investigator considered to have treatment resistant depression (trd), or a history of electroconvulsive therapy (ect), transcranial magnetic stimulation (tms) or psychosurgery within the last year.
Beschrijving

Therapy non-responder | Antidepressant therapy Quantity | Antidepressive Agents Dose Symptom control (therapy) | Depressive Disorder, Treatment-Resistant | Electroconvulsive Therapy | Transcranial magnetic stimulation | Psychosurgery

Datatype

boolean

Alias
UMLS CUI [1]
C0919875
UMLS CUI [2,1]
C1096649
UMLS CUI [2,2]
C1265611
UMLS CUI [3,1]
C0003289
UMLS CUI [3,2]
C0178602
UMLS CUI [3,3]
C1274136
UMLS CUI [4]
C2063866
UMLS CUI [5]
C0013806
UMLS CUI [6]
C0436548
UMLS CUI [7]
C0033967
5. have a history of any seizure disorder.
Beschrijving

Epilepsy

Datatype

boolean

Alias
UMLS CUI [1]
C0014544
6. any clinically significant abnormal vital sign, ecg, laboratory values as determined by the investigator which might interfere with the study.
Beschrijving

Abnormal vital signs Interfere with Clinical Trial | Electrocardiogram abnormal Interferes with Clinical Trial | Laboratory test result abnormal Interferes with Clinical Trial

Datatype

boolean

Alias
UMLS CUI [1,1]
C0277804
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0008976
UMLS CUI [2,1]
C0522055
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0008976
UMLS CUI [3,1]
C0438215
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0008976
7. any organic disorder caused u medical related depression which cannot be under well-controlled such as clinically significant in neurological, gastrointestinal, renal, hepatic, cardiovascular, respiratory, metabolic, endocrine, hematological or other major disorders
Beschrijving

Organic disease caused by Depression | Organic disease Poorly controlled | Nervous system disorder | Gastrointestinal Diseases | Kidney Diseases | Liver diseases | Cardiovascular Diseases | Respiration Disorders | Metabolic Diseases | Endocrine System Diseases | Hematological Disease | Disease Major

Datatype

boolean

Alias
UMLS CUI [1,1]
C0683324
UMLS CUI [1,2]
C0015127
UMLS CUI [1,3]
C0011581
UMLS CUI [2,1]
C0683324
UMLS CUI [2,2]
C3853134
UMLS CUI [3]
C0027765
UMLS CUI [4]
C0017178
UMLS CUI [5]
C0022658
UMLS CUI [6]
C0023895
UMLS CUI [7]
C0007222
UMLS CUI [8]
C0035204
UMLS CUI [9]
C0025517
UMLS CUI [10]
C0014130
UMLS CUI [11]
C0018939
UMLS CUI [12,1]
C0012634
UMLS CUI [12,2]
C0205164
8. have a high suicidal risk as measured by mini.
Beschrijving

High suicide risk

Datatype

boolean

Alias
UMLS CUI [1]
C1271074
9. have a history of substance abuse within the past 6 months or a positive urine drug screen for any substance of abuse at visit 1.
Beschrijving

Substance Use Disorders | Urine drug screen positive

Datatype

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0743300
10. have a history of severe allergies to more than 1 class of medication or multiple adverse drug reactions.
Beschrijving

Drug Allergy Severe | Pharmaceutical Preparations Class Quantity | Adverse reaction to drug multiple

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013182
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0456387
UMLS CUI [2,3]
C1265611
UMLS CUI [3,1]
C0041755
UMLS CUI [3,2]
C0439064
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Similar models

Eligibility Major Depressive Disorder NCT02395978

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Outpatients | Age
Item
1. outpatients aged 20-65 years
boolean
C0029921 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Informed Consent
Item
2. subjects must be able to understand and willing to sign informed consent
boolean
C0021430 (UMLS CUI [1])
Childbearing Potential Pregnancy test negative | Childbearing Potential Contraceptive methods
Item
3. female subjects of child-bearing potential must test negative to pregnancy and use appropriate birth control method from the beginning of study to the 15 days later after ending of study
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
DEPRESSIVE DISORDER MAJOR WITHOUT PSYCHOTIC FEATURE
Item
4. met criteria for mdd without psychotic features as defined by the diagnostic and statistical manual of mental disorders, fourth edition text revision® (dsm-iv-tr) and confirmed by use of the mini international neuropsychiatric interview (mini).
boolean
C0743081 (UMLS CUI [1])
Hamilton Depression Rating Scale 17 Item Clinical Classification | Clinical global impression scale
Item
5. 17-item ham-d (hamilton rating scale for depression) total score ≧20 and cgi (clinical global impression) total score ≧4
boolean
C3639712 (UMLS CUI [1])
C3639708 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Mental disorders Major compromise Clinical Trial | Obsessive-Compulsive Disorder | Post-Traumatic Stress Disorder | Bipolar I disorder | Bipolar II disorder | Manic episode | Hypomanic episode | Schizophrenia | Axis II diagnosis Major | Major depression with psychotic features | Mental Retardation
Item
1. have a current or previous major psychiatric disorders which be defined to be per the dsm-iv-tr, including obsessive-compulsive disorder, posttraumatic stress disorder, bipolar i or ii, manic or hypomanic episode, schizophrenia, major axis ii disorders which might compromise the study, and major depression with psychotic symptoms, mental retardation.
boolean
C0004936 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C2945640 (UMLS CUI [1,3])
C0008976 (UMLS CUI [1,4])
C0028768 (UMLS CUI [2])
C0038436 (UMLS CUI [3])
C0853193 (UMLS CUI [4])
C0236788 (UMLS CUI [5])
C0349208 (UMLS CUI [6])
C1396834 (UMLS CUI [7])
C0036341 (UMLS CUI [8])
C0270288 (UMLS CUI [9,1])
C0205164 (UMLS CUI [9,2])
C4518519 (UMLS CUI [10])
C0025362 (UMLS CUI [11])
Therapeutic procedure Major Depressive Disorder | Fluoxetine
Item
2. use of any treatment for mdd in the last 2 weeks before visit 1 (4 weeks for fluoxetine).
boolean
C0087111 (UMLS CUI [1,1])
C1269683 (UMLS CUI [1,2])
C0016365 (UMLS CUI [2])
Psychotropic Drugs | Exception Relationship Insomnia
Item
3. use of psychoactive drugs within the last 2 weeks before visit 1 other than that subjects had insomnia who need the treatment as determined by the investigator.
boolean
C0033978 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0439849 (UMLS CUI [2,2])
C0917801 (UMLS CUI [2,3])
Therapy non-responder | Antidepressant therapy Quantity | Antidepressive Agents Dose Symptom control (therapy) | Depressive Disorder, Treatment-Resistant | Electroconvulsive Therapy | Transcranial magnetic stimulation | Psychosurgery
Item
4. subjects who were non-responsive to two or more courses of antidepressant medications given an adequate dosage for symptom treatment within four weeks, or by the judgment of the investigator considered to have treatment resistant depression (trd), or a history of electroconvulsive therapy (ect), transcranial magnetic stimulation (tms) or psychosurgery within the last year.
boolean
C0919875 (UMLS CUI [1])
C1096649 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0003289 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C1274136 (UMLS CUI [3,3])
C2063866 (UMLS CUI [4])
C0013806 (UMLS CUI [5])
C0436548 (UMLS CUI [6])
C0033967 (UMLS CUI [7])
Epilepsy
Item
5. have a history of any seizure disorder.
boolean
C0014544 (UMLS CUI [1])
Abnormal vital signs Interfere with Clinical Trial | Electrocardiogram abnormal Interferes with Clinical Trial | Laboratory test result abnormal Interferes with Clinical Trial
Item
6. any clinically significant abnormal vital sign, ecg, laboratory values as determined by the investigator which might interfere with the study.
boolean
C0277804 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0522055 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0008976 (UMLS CUI [2,3])
C0438215 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0008976 (UMLS CUI [3,3])
Organic disease caused by Depression | Organic disease Poorly controlled | Nervous system disorder | Gastrointestinal Diseases | Kidney Diseases | Liver diseases | Cardiovascular Diseases | Respiration Disorders | Metabolic Diseases | Endocrine System Diseases | Hematological Disease | Disease Major
Item
7. any organic disorder caused u medical related depression which cannot be under well-controlled such as clinically significant in neurological, gastrointestinal, renal, hepatic, cardiovascular, respiratory, metabolic, endocrine, hematological or other major disorders
boolean
C0683324 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
C0011581 (UMLS CUI [1,3])
C0683324 (UMLS CUI [2,1])
C3853134 (UMLS CUI [2,2])
C0027765 (UMLS CUI [3])
C0017178 (UMLS CUI [4])
C0022658 (UMLS CUI [5])
C0023895 (UMLS CUI [6])
C0007222 (UMLS CUI [7])
C0035204 (UMLS CUI [8])
C0025517 (UMLS CUI [9])
C0014130 (UMLS CUI [10])
C0018939 (UMLS CUI [11])
C0012634 (UMLS CUI [12,1])
C0205164 (UMLS CUI [12,2])
High suicide risk
Item
8. have a high suicidal risk as measured by mini.
boolean
C1271074 (UMLS CUI [1])
Substance Use Disorders | Urine drug screen positive
Item
9. have a history of substance abuse within the past 6 months or a positive urine drug screen for any substance of abuse at visit 1.
boolean
C0038586 (UMLS CUI [1])
C0743300 (UMLS CUI [2])
Drug Allergy Severe | Pharmaceutical Preparations Class Quantity | Adverse reaction to drug multiple
Item
10. have a history of severe allergies to more than 1 class of medication or multiple adverse drug reactions.
boolean
C0013182 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C0456387 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0041755 (UMLS CUI [3,1])
C0439064 (UMLS CUI [3,2])
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