ID

15418

Beskrivning

Open Label Extension for GLYX13-C-202, NCT01684163; ODM derived from: https://clinicaltrials.gov/show/NCT02192099

Länk

https://clinicaltrials.gov/show/NCT02192099

Nyckelord

Versioner (1)
  1. 2016-05-31 2016-05-31 -
Uppladdad den

31 maj 2016

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Major Depressive Disorder NCT02192099

Engelsk

Eligibility Major Depressive Disorder NCT02192099

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. participants who have completed 8 weeks of treatment in the preceding study (glyx13-c-202, nct01684163.
Beskrivning

Therapeutic procedure Week Complete | Clinical Trial preceding | GLYX-13 peptide

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0439230
UMLS CUI [1,3]
C0205197
UMLS CUI [2,1]
C0008976
UMLS CUI [2,2]
C0332152
UMLS CUI [3]
C1666271
2. participants who wish to continue treatment with glyx-13 after the preceding study.
Beskrivning

continuing therapy GLYX-13 peptide Willing

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1553904
UMLS CUI [1,2]
C1666271
UMLS CUI [1,3]
C0600109
3. meets diagnostic and statistical manual, fourth edition, text revision (dsm-iv-tr) criteria for major depressive disorder (mdd).
Beskrivning

Major Depressive Disorder Diagnostic Criteria Met DSM-IV

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1269683
UMLS CUI [1,2]
C3897171
UMLS CUI [1,3]
C0220952
4. female subjects of childbearing potential with a negative serum pregnancy test prior to entry into the study and who are practicing an adequate method of birth control (eg oral or parenteral contraceptives, intrauterine device, barrier, abstinence) and who do not plan to become pregnant during the course of the study. female subjects may be included without a negative serum pregnancy test if they are surgically sterile or at least 2 years post-menopausal.
Beskrivning

Childbearing Potential Serum pregnancy test negative Contraceptive methods | Contraceptives, Oral | Contraceptive Agents Parenteral | Intrauterine Devices | Contraception, Barrier | Sexual Abstinence | Pregnancy, Planned | Female Sterilization | Postmenopausal state

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430061
UMLS CUI [1,3]
C0700589
UMLS CUI [2]
C0009905
UMLS CUI [3,1]
C0009871
UMLS CUI [3,2]
C1518896
UMLS CUI [4]
C0021900
UMLS CUI [5]
C0004764
UMLS CUI [6]
C0036899
UMLS CUI [7]
C0032992
UMLS CUI [8]
C0015787
UMLS CUI [9]
C0232970
5. clinical laboratory values <2 times the upper limit of normal (uln) or deemed not clinically significant per the investigator and naurex medical monitor.
Beskrivning

Laboratory Procedures | Clinical Significance

Datatyp

boolean

Alias
UMLS CUI [1]
C0022885
UMLS CUI [2]
C2826293
6. ability to understand the requirements of the study, provide written informed consent, abide by the study restrictions, and agree to return for the required assessments.
Beskrivning

Comprehension Study Protocol | Informed Consent | Compliance behavior

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C2348563
UMLS CUI [2]
C0021430
UMLS CUI [3]
C1321605
7. based on the investigator and naurex medical monitor's clinical judgment, subjects with eating disorders, obsessive compulsive disorder (ocd), panic disorder, post-traumatic stress disorder (ptsd), and generalized anxiety disorders secondary to major depressive episodes (mdes) are permitted.
Beskrivning

Eating Disorders | Obsessive-Compulsive Disorder | Panic Disorder | Post-Traumatic Stress Disorder | Generalized Anxiety Disorder | Single major depressive episode

Datatyp

boolean

Alias
UMLS CUI [1]
C0013473
UMLS CUI [2]
C0028768
UMLS CUI [3]
C0030319
UMLS CUI [4]
C0038436
UMLS CUI [5]
C0270549
UMLS CUI [6]
C0024517
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. axis i diagnosis of delirium, dementia, dysthymia, amnestic or other cognitive disorder, schizophrenia or other psychotic disorder, bipolar i or ii disorder, eating disorder (anorexia or bulimia nervosa), obsessive-compulsive disorder, panic disorder, acute stress disorder, agoraphobia, social phobia, attention-deficit hyperactivity disorder (adhd), or ptsd.
Beskrivning

Delirium Axis I diagnosis | Dementia | Dysthymic Disorder | Amnestic Disorder | Cognition Disorders | Schizophrenia | Psychotic Disorders | Bipolar Disorder | Eating Disorders | Anorexia | Bulimia Nervosa | Obsessive-Compulsive Disorder | Panic Disorder | Stress Disorders, Traumatic, Acute | Agoraphobia | Phobia, Social | Attention deficit hyperactivity disorder | Post-Traumatic Stress Disorder

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0011206
UMLS CUI [1,2]
C0270287
UMLS CUI [2]
C0497327
UMLS CUI [3]
C0013415
UMLS CUI [4]
C0002625
UMLS CUI [5]
C0009241
UMLS CUI [6]
C0036341
UMLS CUI [7]
C0033975
UMLS CUI [8]
C0005586
UMLS CUI [9]
C0013473
UMLS CUI [10]
C0003123
UMLS CUI [11]
C2267227
UMLS CUI [12]
C0028768
UMLS CUI [13]
C0030319
UMLS CUI [14]
C0236816
UMLS CUI [15]
C0001818
UMLS CUI [16]
C0031572
UMLS CUI [17]
C1263846
UMLS CUI [18]
C0038436
2. a clinically significant current axis ii diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal, or histrionic personality disorder
Beskrivning

Axis II diagnosis | Borderline Personality Disorder | Antisocial Personality Disorder | Paranoid Personality Disorder | Schizoid Personality Disorder | Schizotypal Personality Disorder | Histrionic Personality Disorder

Datatyp

boolean

Alias
UMLS CUI [1]
C0270288
UMLS CUI [2]
C0006012
UMLS CUI [3]
C0003431
UMLS CUI [4]
C0030477
UMLS CUI [5]
C0036339
UMLS CUI [6]
C0036363
UMLS CUI [7]
C0019681
3. experiencing hallucinations, delusions, or any psychotic symptomatology in the current episode; lifetime history of psychosis.
Beskrivning

Hallucinations | Delusions | Depressive episode Psychotic symptom | Chronic psychosis Lifelong

Datatyp

boolean

Alias
UMLS CUI [1]
C0018524
UMLS CUI [2]
C0011253
UMLS CUI [3,1]
C0349217
UMLS CUI [3,2]
C0871189
UMLS CUI [4,1]
C0221764
UMLS CUI [4,2]
C3280928
4. huntington's, parkinson's, alzheimer's, multiple sclerosis, or a history of seizures or strokes.
Beskrivning

Huntington Disease | Parkinson Disease | Alzheimer's Disease | Multiple Sclerosis | Seizures | Cerebrovascular accident

Datatyp

boolean

Alias
UMLS CUI [1]
C0020179
UMLS CUI [2]
C0030567
UMLS CUI [3]
C0002395
UMLS CUI [4]
C0026769
UMLS CUI [5]
C0036572
UMLS CUI [6]
C0038454
5. currently hospitalized or residing in an in-patient facility during study participation.
Beskrivning

Hospitalization | Inpatient facility Resident

Datatyp

boolean

Alias
UMLS CUI [1]
C0019993
UMLS CUI [2,1]
C1830584
UMLS CUI [2,2]
C2347958
6. substance abuse since the end of participation in glyx13-c-202, including greater than or equal to 5 units of alcohol per day where 1 unit = ½ pint of beer, 1 glass of wine 4 oz, or 1 oz. of spirits consumed most weeks or in the opinion of the investigator
Beskrivning

Substance Use Disorders | GLYX-13

Datatyp

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C1666271
7. women who are planning to become pregnant during the course of the study.
Beskrivning

Pregnancy, Planned

Datatyp

boolean

Alias
UMLS CUI [1]
C0032992
8. allergy or intolerance to current antidepressant or other current medications.
Beskrivning

Hypersensitivity Antidepressive Agents | Intolerance to Antidepressive Agents | Hypersensitivity Pharmaceutical Preparation | Intolerance to Pharmaceutical Preparation

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0003289
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C0003289
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0013227
UMLS CUI [4,1]
C1744706
UMLS CUI [4,2]
C0013227
9. participation in any clinical trial of an investigational product or device within 30 days of enrollment in this trial with the exception of glyx13-c-202.
Beskrivning

Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device | GLYX-13

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C2346570
UMLS CUI [4]
C1666271
10. positive screen for drugs of abuse: cocaine, marijuana, pcp, ketamine, opioid or other agent that in the opinion of the investigator is being abused
Beskrivning

Drug abuse | Cocaine | Marihuana | Phencyclidine | Ketamine | Opioids

Datatyp

boolean

Alias
UMLS CUI [1]
C0013146
UMLS CUI [2]
C0009170
UMLS CUI [3]
C0024808
UMLS CUI [4]
C0031381
UMLS CUI [5]
C0022614
UMLS CUI [6]
C0242402
11. pose current (past 6 months) suicide risk based on administration of the c ssrs and the investigator's clinical judgment.
Beskrivning

At risk for suicide | Columbia suicide severity rating scale

Datatyp

boolean

Alias
UMLS CUI [1]
C0563664
UMLS CUI [2]
C3888485
12. human immunodeficiency virus (hiv) infection (based on the based on the hiv-1 & hiv-2 antibody screen) or other ongoing infectious disease.
Beskrivning

HIV Infections | HIV-1 HIV-2 Antibody Measurement | Communicable Diseases

Datatyp

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C2697540
UMLS CUI [3]
C0009450
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Similar models

Eligibility Major Depressive Disorder NCT02192099

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Therapeutic procedure Week Complete | Clinical Trial preceding | GLYX-13 peptide
Item
1. participants who have completed 8 weeks of treatment in the preceding study (glyx13-c-202, nct01684163.
boolean
C0087111 (UMLS CUI [1,1])
C0439230 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
C0008976 (UMLS CUI [2,1])
C0332152 (UMLS CUI [2,2])
C1666271 (UMLS CUI [3])
continuing therapy GLYX-13 peptide Willing
Item
2. participants who wish to continue treatment with glyx-13 after the preceding study.
boolean
C1553904 (UMLS CUI [1,1])
C1666271 (UMLS CUI [1,2])
C0600109 (UMLS CUI [1,3])
Major Depressive Disorder Diagnostic Criteria Met DSM-IV
Item
3. meets diagnostic and statistical manual, fourth edition, text revision (dsm-iv-tr) criteria for major depressive disorder (mdd).
boolean
C1269683 (UMLS CUI [1,1])
C3897171 (UMLS CUI [1,2])
C0220952 (UMLS CUI [1,3])
Childbearing Potential Serum pregnancy test negative Contraceptive methods | Contraceptives, Oral | Contraceptive Agents Parenteral | Intrauterine Devices | Contraception, Barrier | Sexual Abstinence | Pregnancy, Planned | Female Sterilization | Postmenopausal state
Item
4. female subjects of childbearing potential with a negative serum pregnancy test prior to entry into the study and who are practicing an adequate method of birth control (eg oral or parenteral contraceptives, intrauterine device, barrier, abstinence) and who do not plan to become pregnant during the course of the study. female subjects may be included without a negative serum pregnancy test if they are surgically sterile or at least 2 years post-menopausal.
boolean
C3831118 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])
C0009905 (UMLS CUI [2])
C0009871 (UMLS CUI [3,1])
C1518896 (UMLS CUI [3,2])
C0021900 (UMLS CUI [4])
C0004764 (UMLS CUI [5])
C0036899 (UMLS CUI [6])
C0032992 (UMLS CUI [7])
C0015787 (UMLS CUI [8])
C0232970 (UMLS CUI [9])
Laboratory Procedures | Clinical Significance
Item
5. clinical laboratory values <2 times the upper limit of normal (uln) or deemed not clinically significant per the investigator and naurex medical monitor.
boolean
C0022885 (UMLS CUI [1])
C2826293 (UMLS CUI [2])
Comprehension Study Protocol | Informed Consent | Compliance behavior
Item
6. ability to understand the requirements of the study, provide written informed consent, abide by the study restrictions, and agree to return for the required assessments.
boolean
C0162340 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2])
C1321605 (UMLS CUI [3])
Eating Disorders | Obsessive-Compulsive Disorder | Panic Disorder | Post-Traumatic Stress Disorder | Generalized Anxiety Disorder | Single major depressive episode
Item
7. based on the investigator and naurex medical monitor's clinical judgment, subjects with eating disorders, obsessive compulsive disorder (ocd), panic disorder, post-traumatic stress disorder (ptsd), and generalized anxiety disorders secondary to major depressive episodes (mdes) are permitted.
boolean
C0013473 (UMLS CUI [1])
C0028768 (UMLS CUI [2])
C0030319 (UMLS CUI [3])
C0038436 (UMLS CUI [4])
C0270549 (UMLS CUI [5])
C0024517 (UMLS CUI [6])
Item Group
C0680251 (UMLS CUI)
Delirium Axis I diagnosis | Dementia | Dysthymic Disorder | Amnestic Disorder | Cognition Disorders | Schizophrenia | Psychotic Disorders | Bipolar Disorder | Eating Disorders | Anorexia | Bulimia Nervosa | Obsessive-Compulsive Disorder | Panic Disorder | Stress Disorders, Traumatic, Acute | Agoraphobia | Phobia, Social | Attention deficit hyperactivity disorder | Post-Traumatic Stress Disorder
Item
1. axis i diagnosis of delirium, dementia, dysthymia, amnestic or other cognitive disorder, schizophrenia or other psychotic disorder, bipolar i or ii disorder, eating disorder (anorexia or bulimia nervosa), obsessive-compulsive disorder, panic disorder, acute stress disorder, agoraphobia, social phobia, attention-deficit hyperactivity disorder (adhd), or ptsd.
boolean
C0011206 (UMLS CUI [1,1])
C0270287 (UMLS CUI [1,2])
C0497327 (UMLS CUI [2])
C0013415 (UMLS CUI [3])
C0002625 (UMLS CUI [4])
C0009241 (UMLS CUI [5])
C0036341 (UMLS CUI [6])
C0033975 (UMLS CUI [7])
C0005586 (UMLS CUI [8])
C0013473 (UMLS CUI [9])
C0003123 (UMLS CUI [10])
C2267227 (UMLS CUI [11])
C0028768 (UMLS CUI [12])
C0030319 (UMLS CUI [13])
C0236816 (UMLS CUI [14])
C0001818 (UMLS CUI [15])
C0031572 (UMLS CUI [16])
C1263846 (UMLS CUI [17])
C0038436 (UMLS CUI [18])
Axis II diagnosis | Borderline Personality Disorder | Antisocial Personality Disorder | Paranoid Personality Disorder | Schizoid Personality Disorder | Schizotypal Personality Disorder | Histrionic Personality Disorder
Item
2. a clinically significant current axis ii diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal, or histrionic personality disorder
boolean
C0270288 (UMLS CUI [1])
C0006012 (UMLS CUI [2])
C0003431 (UMLS CUI [3])
C0030477 (UMLS CUI [4])
C0036339 (UMLS CUI [5])
C0036363 (UMLS CUI [6])
C0019681 (UMLS CUI [7])
Hallucinations | Delusions | Depressive episode Psychotic symptom | Chronic psychosis Lifelong
Item
3. experiencing hallucinations, delusions, or any psychotic symptomatology in the current episode; lifetime history of psychosis.
boolean
C0018524 (UMLS CUI [1])
C0011253 (UMLS CUI [2])
C0349217 (UMLS CUI [3,1])
C0871189 (UMLS CUI [3,2])
C0221764 (UMLS CUI [4,1])
C3280928 (UMLS CUI [4,2])
Huntington Disease | Parkinson Disease | Alzheimer's Disease | Multiple Sclerosis | Seizures | Cerebrovascular accident
Item
4. huntington's, parkinson's, alzheimer's, multiple sclerosis, or a history of seizures or strokes.
boolean
C0020179 (UMLS CUI [1])
C0030567 (UMLS CUI [2])
C0002395 (UMLS CUI [3])
C0026769 (UMLS CUI [4])
C0036572 (UMLS CUI [5])
C0038454 (UMLS CUI [6])
Hospitalization | Inpatient facility Resident
Item
5. currently hospitalized or residing in an in-patient facility during study participation.
boolean
C0019993 (UMLS CUI [1])
C1830584 (UMLS CUI [2,1])
C2347958 (UMLS CUI [2,2])
Substance Use Disorders | GLYX-13
Item
6. substance abuse since the end of participation in glyx13-c-202, including greater than or equal to 5 units of alcohol per day where 1 unit = ½ pint of beer, 1 glass of wine 4 oz, or 1 oz. of spirits consumed most weeks or in the opinion of the investigator
boolean
C0038586 (UMLS CUI [1])
C1666271 (UMLS CUI [2])
Pregnancy, Planned
Item
7. women who are planning to become pregnant during the course of the study.
boolean
C0032992 (UMLS CUI [1])
Hypersensitivity Antidepressive Agents | Intolerance to Antidepressive Agents | Hypersensitivity Pharmaceutical Preparation | Intolerance to Pharmaceutical Preparation
Item
8. allergy or intolerance to current antidepressant or other current medications.
boolean
C0020517 (UMLS CUI [1,1])
C0003289 (UMLS CUI [1,2])
C1744706 (UMLS CUI [2,1])
C0003289 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0013227 (UMLS CUI [3,2])
C1744706 (UMLS CUI [4,1])
C0013227 (UMLS CUI [4,2])
Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device | GLYX-13
Item
9. participation in any clinical trial of an investigational product or device within 30 days of enrollment in this trial with the exception of glyx13-c-202.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C2346570 (UMLS CUI [3])
C1666271 (UMLS CUI [4])
Drug abuse | Cocaine | Marihuana | Phencyclidine | Ketamine | Opioids
Item
10. positive screen for drugs of abuse: cocaine, marijuana, pcp, ketamine, opioid or other agent that in the opinion of the investigator is being abused
boolean
C0013146 (UMLS CUI [1])
C0009170 (UMLS CUI [2])
C0024808 (UMLS CUI [3])
C0031381 (UMLS CUI [4])
C0022614 (UMLS CUI [5])
C0242402 (UMLS CUI [6])
At risk for suicide | Columbia suicide severity rating scale
Item
11. pose current (past 6 months) suicide risk based on administration of the c ssrs and the investigator's clinical judgment.
boolean
C0563664 (UMLS CUI [1])
C3888485 (UMLS CUI [2])
HIV Infections | HIV-1 HIV-2 Antibody Measurement | Communicable Diseases
Item
12. human immunodeficiency virus (hiv) infection (based on the based on the hiv-1 & hiv-2 antibody screen) or other ongoing infectious disease.
boolean
C0019693 (UMLS CUI [1])
C2697540 (UMLS CUI [2])
C0009450 (UMLS CUI [3])
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