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Trial record 88 of 179 for:    DCLRE1C

Open Label Extension for GLYX13-C-202, NCT01684163

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02192099
Recruitment Status : Completed
First Posted : July 16, 2014
Last Update Posted : March 14, 2019
Sponsor:
Information provided by (Responsible Party):
Naurex, Inc, an affiliate of Allergan plc

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

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: GLYX-13 10 mg/kg Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : September 8, 2014
Actual Primary Completion Date : November 8, 2018
Actual Study Completion Date : November 8, 2018

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Arm Intervention/treatment
Experimental: GLYX-13 10 mg/kg
IV Dose of GLYX-13
Drug: GLYX-13 10 mg/kg
Intravenous administration of 10 mg/kg into arm. Can be adjusted to 5 mg/kg weekly or biweekly.
Other Name: GLYX-13 IV Dose




Primary Outcome Measures :
  1. Adverse events [ Time Frame: 48 months ]

Secondary Outcome Measures :
  1. Change in HDRS-17 to end of participation [ Time Frame: 48 months ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02192099


Locations
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United States, Alabama
Office of Psychiatric Research
Birmingham, Alabama, United States, 35294
United States, California
Artemis Institute for Clinical Research
San Diego, California, United States, 92103
United States, Illinois
Chicago Research Center
Chicago, Illinois, United States, 60634
United States, Kansas
University of Kansas School of Medicine Clinical Trial Unit
Wichita, Kansas, United States, 67214
United States, Maryland
PharmaSite Research, Inc.
Baltimore, Maryland, United States, 21208
United States, Massachusetts
Boston Clinical Trials Inc.
Roslindale, Massachusetts, United States, 02131
United States, New Jersey
Woodlands Professional Princeton Medical Institute Building
Princeton, New Jersey, United States, 08540
United States, New York
Finger Lake Clinical Research
Rochester, New York, United States, 14618
United States, Ohio
Lindner Center of HOPE
Mason, Ohio, United States, 45040
United States, Utah
PRA Health Sciences Phase 2/3 Outpatient & CNS Clinic
Salt Lake City, Utah, United States, 84107
Sponsors and Collaborators
Naurex, Inc, an affiliate of Allergan plc
Investigators
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Study Director: Raffaele Migliore Allergan

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Responsible Party: Naurex, Inc, an affiliate of Allergan plc
ClinicalTrials.gov Identifier: NCT02192099     History of Changes
Other Study ID Numbers: GLYX13-C-203
First Posted: July 16, 2014    Key Record Dates
Last Update Posted: March 14, 2019
Last Verified: March 2019

Additional relevant MeSH terms:
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Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms