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Open Label Extension for GLYX13-C-202, NCT01684163

8. november 2019 oppdatert av: Naurex, Inc, an affiliate of Allergan plc

Phase 2, Open Label Extension for Subjects With Inadequate/Partial Response to Antidepressants During the Current Episode of Major Depressive Disorder Previously Treated With GLYX-13 (Extension of GLYX13-C-202, NCT01684163)

Examine the safety of long term repeat exposure to GLYX-13 in subjects who participated in GLYX13-C-202.

Studieoversikt

Detaljert beskrivelse

Examine the safety of long term repeat exposure to GLYX-13 in subjects who participated in GLYX13-C-202 in an open label extension trial.

Studietype

Intervensjonell

Registrering (Faktiske)

61

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Alabama
      • Birmingham, Alabama, Forente stater, 35294
        • Office of Psychiatric Research
    • California
      • San Diego, California, Forente stater, 92103
        • Artemis Institute for Clinical Research
    • Illinois
      • Chicago, Illinois, Forente stater, 60634
        • Chicago Research Center
    • Kansas
      • Wichita, Kansas, Forente stater, 67214
        • University of Kansas School of Medicine Clinical Trial Unit
    • Maryland
      • Baltimore, Maryland, Forente stater, 21208
        • Pharmasite Research, Inc.
    • Massachusetts
      • Roslindale, Massachusetts, Forente stater, 02131
        • Boston Clinical Trials Inc.
    • New Jersey
      • Princeton, New Jersey, Forente stater, 08540
        • Woodlands Professional Princeton Medical Institute Building
    • New York
      • Rochester, New York, Forente stater, 14618
        • Finger Lake Clinical Research
    • Ohio
      • Mason, Ohio, Forente stater, 45040
        • Lindner Center of Hope
    • Utah
      • Salt Lake City, Utah, Forente stater, 84107
        • PRA Health Sciences Phase 2/3 Outpatient & CNS Clinic

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 75 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  1. Participants who have completed 8 weeks of treatment in the preceding study (GLYX13-C-202, NCT01684163.
  2. Participants who wish to continue treatment with GLYX-13 after the preceding study.
  3. Meets Diagnostic and Statistical Manual, Fourth Edition, Text Revision (DSM-IV-TR) criteria for major depressive disorder (MDD).
  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.
  5. Clinical laboratory values <2 times the upper limit of normal (ULN) or deemed not clinically significant per the investigator and Naurex medical monitor.
  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.
  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.

Exclusion Criteria:

  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.
  2. A clinically significant current Axis II diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal, or histrionic personality disorder
  3. Experiencing hallucinations, delusions, or any psychotic symptomatology in the current episode; lifetime history of psychosis.
  4. Huntington's, Parkinson's, Alzheimer's, Multiple Sclerosis, or a history of seizures or strokes.
  5. Currently hospitalized or residing in an in-patient facility during study participation.
  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
  7. Women who are planning to become pregnant during the course of the study.
  8. Allergy or intolerance to current antidepressant or other current medications.
  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.
  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
  11. Pose current (past 6 months) suicide risk based on administration of the C SSRS and the investigator's clinical judgment.
  12. Human immunodeficiency virus (HIV) infection (based on the based on the HIV-1 & HIV-2 antibody screen) or other ongoing infectious disease.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Rapastinel (225 mg/450 mg IV administration) prefilled syringe
Investigators began treatment in RAP-MD-05 based on the dose level to which the patient was assigned during participation in GLYX13-C-202; patients originally assigned to rapastinel 5 mg/kg received rapastinel 225 mg, and patients originally assigned to rapastinel 10 mg/kg received rapastinel 450 mg. Investigators had the option to decrease the dose level from 450 to 225 mg if a patient experienced an adverse event(s) that the investigator believed may be associated with rapastinel
Investigators began treatment in RAP-MD-05 based on the dose level to which the patient was assigned during participation in GLYX13-C-202; patients originally assigned to rapastinel 5 mg/kg received rapastinel 225 mg, and patients originally assigned to rapastinel 10 mg/kg received rapastinel 450 mg. Investigators had the option to decrease the dose level from 450 to 225 mg if a patient experienced an adverse event(s) that the investigator believed may be associated with rapastinel
Andre navn:
  • GLYX-13 IV Dose

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
The Number of Participants Who Experience an Adverse Event Over the Course of the Study.
Tidsramme: 48 Months
An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. A TEAE was an AE that occurred after receiving the first dose of investigational product or an AE present prior to first dose but increased in severity during the Treatment Period.
48 Months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

8. september 2014

Primær fullføring (Faktiske)

8. november 2018

Studiet fullført (Faktiske)

8. november 2018

Datoer for studieregistrering

Først innsendt

8. juli 2014

Først innsendt som oppfylte QC-kriteriene

14. juli 2014

Først lagt ut (Anslag)

16. juli 2014

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

27. november 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

8. november 2019

Sist bekreftet

1. november 2019

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • GLYX13-C-203

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på Major depressiv lidelse

Kliniske studier på Rapastinel (225 mg/450 mg IV administration)

3
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