Open Label Extension for GLYX13-C-202, NCT01684163
8 november 2019 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
61
Fas
- Fas 2
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Alabama
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Birmingham, Alabama, Förenta staterna, 35294
- Office of Psychiatric Research
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California
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San Diego, California, Förenta staterna, 92103
- Artemis Institute for Clinical Research
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Illinois
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Chicago, Illinois, Förenta staterna, 60634
- Chicago Research Center
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Kansas
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Wichita, Kansas, Förenta staterna, 67214
- University of Kansas School of Medicine Clinical Trial Unit
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Maryland
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Baltimore, Maryland, Förenta staterna, 21208
- Pharmasite Research, Inc.
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Massachusetts
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Roslindale, Massachusetts, Förenta staterna, 02131
- Boston Clinical Trials Inc.
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New Jersey
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Princeton, New Jersey, Förenta staterna, 08540
- Woodlands Professional Princeton Medical Institute Building
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New York
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Rochester, New York, Förenta staterna, 14618
- Finger Lake Clinical Research
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Ohio
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Mason, Ohio, Förenta staterna, 45040
- Lindner Center of Hope
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Utah
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Salt Lake City, Utah, Förenta staterna, 84107
- PRA Health Sciences Phase 2/3 Outpatient & CNS Clinic
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 75 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Participants who have completed 8 weeks of treatment in the preceding study (GLYX13-C-202, NCT01684163.
- Participants who wish to continue treatment with GLYX-13 after the preceding study.
- Meets Diagnostic and Statistical Manual, Fourth Edition, Text Revision (DSM-IV-TR) criteria for major depressive disorder (MDD).
- 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.
- Clinical laboratory values <2 times the upper limit of normal (ULN) or deemed not clinically significant per the investigator and Naurex medical monitor.
- 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.
- 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:
- 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.
- A clinically significant current Axis II diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal, or histrionic personality disorder
- Experiencing hallucinations, delusions, or any psychotic symptomatology in the current episode; lifetime history of psychosis.
- Huntington's, Parkinson's, Alzheimer's, Multiple Sclerosis, or a history of seizures or strokes.
- Currently hospitalized or residing in an in-patient facility during study participation.
- 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
- Women who are planning to become pregnant during the course of the study.
- Allergy or intolerance to current antidepressant or other current medications.
- 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.
- Positive screen for drugs of abuse: cocaine, marijuana, PCP, ketamine, opioid or other agent that in the opinion of the investigator is being abused
- Pose current (past 6 months) suicide risk based on administration of the C SSRS and the investigator's clinical judgment.
- Human immunodeficiency virus (HIV) infection (based on the based on the HIV-1 & HIV-2 antibody screen) or other ongoing infectious disease.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: 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
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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
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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The Number of Participants Who Experience an Adverse Event Over the Course of the Study.
Tidsram: 48 Months
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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.
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48 Months
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Samarbetspartners och utredare
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Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
8 september 2014
Primärt slutförande (Faktisk)
8 november 2018
Avslutad studie (Faktisk)
8 november 2018
Studieregistreringsdatum
Först inskickad
8 juli 2014
Först inskickad som uppfyllde QC-kriterierna
14 juli 2014
Första postat (Uppskatta)
16 juli 2014
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
27 november 2019
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
8 november 2019
Senast verifierad
1 november 2019
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- GLYX13-C-203
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .