Clinical trial NCT02192099: Open Label Extension for GLYX13-C-202, NCT01684163
Official title: 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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Major Depressive Disorder
Lead sponsor: Naurex, Inc, an affiliate of Allergan plc
Sponsor class: INDUSTRY
First posted: 2014-07-16
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: The Number of Participants Who Experience an Adverse Event Over the Course of the Study.
timeFrame: 48 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Office of Psychiatric Research
state: Alabama
city: San Diego
country: United States
facility: Artemis Institute for Clinical Research
state: California
city: Chicago
country: United States
facility: Chicago Research Center
state: Illinois
city: Wichita
country: United States
facility: University of Kansas School of Medicine Clinical Trial Unit
state: Kansas
city: Baltimore
country: United States
facility: PharmaSite Research, Inc.
state: Maryland
city: Roslindale
country: United States
facility: Boston Clinical Trials Inc.
state: Massachusetts
city: Princeton
country: United States
facility: Woodlands Professional Princeton Medical Institute Building
state: New Jersey
city: Rochester
country: United States
facility: Finger Lake Clinical Research
state: New York
city: Mason
country: United States
facility: Lindner Center of HOPE
state: Ohio
city: Salt Lake City
country: United States
facility: PRA Health Sciences Phase 2/3 Outpatient & CNS Clinic
state: Utah
Study officials:
affiliation: Allergan
name: Jenna Hoogerheyde
role: STUDY_DIRECTOR
References: