Open Label Extension for GLYX13-C-202, NCT01684163
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Rapastinel (225 mg/450 mg IV administration)
Intervention description: 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
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 61.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

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

Eligibility criteria:

        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.