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])
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])