Major Depressive Disorder
Conditions
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.
Interventions
DRUGRapastinel (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
Sponsors
Naurex, Inc, an affiliate of Allergan plc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Number of Participants Who Experience an Adverse Event Over the Course of the Study. | 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. |
Countries
United States
Participant flow
Pre-assignment details
Outpatients who have completed 8 or more weeks of treatment in the preceding study (GLYX13-C-202) and were willing to continue treatment with rapastinel (GLYX-13). 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.
Participants by arm
| Arm | Count |
|---|---|
| Rapastinel (GLYX-13) 225mg or 450 mg IV Administration Rapastinel (225 mg/450 mg intravenous \[IV\] administration), prefilled syringe. | 61 |
| Total | 61 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Miscellaneous Reasons | 5 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Pregnancy | 1 |
| Overall Study | Protocol Violation | 8 |
| Overall Study | Study Terminated by Sponsor | 32 |
| Overall Study | Withdrawal by Subject | 11 |
Baseline characteristics
| Characteristic | Rapastinel (GLYX-13) 225mg or 450 mg IV Administration |
|---|---|
| Age, Continuous | 49.4 Years STANDARD_DEVIATION 10.02 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 57 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 13 Participants |
| Race/Ethnicity, Customized White | 48 Participants |
| Sex: Female, Male Female | 46 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 61 |
| other Total, other adverse events | 60 / 61 |
| serious Total, serious adverse events | 14 / 61 |
Outcome results
Primary
The Number of Participants Who Experience an Adverse Event Over the Course of the Study.
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.
Time frame: 48 Months
Population: The Safety Population will consist of all subjects who received any injection of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rapastinel (GLYX-13) 225mg or 450 mg IV Administration | The Number of Participants Who Experience an Adverse Event Over the Course of the Study. | 60 Participants |