Open Label Extension for GLYX13-C-202, NCT01684163

NCT ID: NCT02192099

Last Updated: 2019-11-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-08
• Study Completion Date: 2018-11-08

Brief Summary

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

Detailed Description

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.

Conditions

Major Depressive Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Rapastinel (225 mg/450 mg IV administration)

Intervention Type: DRUG

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

Interventions

Rapastinel (225 mg/450 mg IV administration)

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

Intervention Type: DRUG

Other Intervention Names

GLYX-13 IV Dose

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Naurex, Inc, an affiliate of Allergan plc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jenna Hoogerheyde

Role: STUDY_DIRECTOR

Allergan

Locations

Office of Psychiatric Research

Birmingham, Alabama, United States

Artemis Institute for Clinical Research

San Diego, California, United States

Chicago Research Center

Chicago, Illinois, United States

University of Kansas School of Medicine Clinical Trial Unit

Wichita, Kansas, United States

PharmaSite Research, Inc.

Baltimore, Maryland, United States

Boston Clinical Trials Inc.

Roslindale, Massachusetts, United States

Woodlands Professional Princeton Medical Institute Building

Princeton, New Jersey, United States

Finger Lake Clinical Research

Rochester, New York, United States

Lindner Center of HOPE

Mason, Ohio, United States

PRA Health Sciences Phase 2/3 Outpatient & CNS Clinic

Salt Lake City, Utah, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

GLYX13-C-203

Identifier Type: -

Identifier Source: org_study_id