<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01684163</url>
  </required_header>
  <id_info>
    <org_study_id>GLYX13-C-202</org_study_id>
    <nct_id>NCT01684163</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of GLYX-13 in Subjects With Inadequate/Partial Response to Antidepressants</brief_title>
  <official_title>Phase 2, Double-Blind, Placebo Controlled, Randomized Withdrawal, Parallel Efficacy and Safety Study of GLYX-13 in Subjects With Inadequate/Partial Response to Antidepressants During the Current Episode of Major Depressive Disorder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Naurex, Inc, an affiliate of Allergan plc</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Naurex, Inc, an affiliate of Allergan plc</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      GLYX-13 is a NMDA receptor glycine site partial agonist being studied in subjects with major&#xD;
      depressive disorder (depression) who have responded inadequately to another antidepressant&#xD;
      drug during the current episode. This trial will assess the effects of GLYX-13 on depression&#xD;
      when added to another antidepressant drug that the patient is already taking.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To evaluate the mean difference in Hamilton Depression Rating Scale 17 (HDRS-17) score for&#xD;
      the combined GLYX-13 mean change versus the placebo group mean change at the end of a 6 week&#xD;
      randomized withdrawal phase (predose baseline score - score at end of randomized withdrawal&#xD;
      period).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">June 2014</completion_date>
  <primary_completion_date type="Actual">April 2014</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Hamilton Depression Rating Scale Score</measure>
    <time_frame>6 weeks, 12 weeks, 16 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical Global Impression of Change</measure>
    <time_frame>6 weeks, 12 weeks, 16 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">369</enrollment>
  <condition>Major Depressive Disorder</condition>
  <arm_group>
    <arm_group_label>Placebo injection</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Normal saline</description>
  </arm_group>
  <arm_group>
    <arm_group_label>GLYX-13, 5 mg/kg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Low dose of GLYX-13</description>
  </arm_group>
  <arm_group>
    <arm_group_label>GLYX-13, 10 mg/kg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>High dose of GLYX-13</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>GLYX-13 5 mg/kg</intervention_name>
    <description>Intravenous administration of 5 mg/kg into arm.</description>
    <arm_group_label>GLYX-13, 5 mg/kg</arm_group_label>
    <other_name>GLYX-13 IV Dose</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>GLYX-13 10 mg/kg</intervention_name>
    <description>Intravenous administration of 10 mg/kg into arm.</description>
    <arm_group_label>GLYX-13, 10 mg/kg</arm_group_label>
    <other_name>GLYX-13 IV Dose</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Intravenous administration of normal saline into arm.</description>
    <arm_group_label>Placebo injection</arm_group_label>
    <other_name>Normal Saline</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female subjects&#xD;
&#xD;
          -  Aged 18 to 65 years&#xD;
&#xD;
          -  Meets DSM-IV-TR) criteria for major depressive disorder (MDD)&#xD;
&#xD;
          -  Current episode has lasted ≥ 8 weeks before Screening with an inadequate response to&#xD;
             all approved antidepressant agent(s) administered at an adequate dose and duration for&#xD;
             the current episode&#xD;
&#xD;
          -  Taking no antidepressant agent currently or taking an SSRI or SNRI&#xD;
&#xD;
          -  HDRS-17 score ≥ 18 at screening and predose baseline&#xD;
&#xD;
          -  Female subjects of childbearing potential with a negative serum pregnancy test prior&#xD;
             to entry into the study and who are practicing an adequate method of birth control and&#xD;
             who do not plan to become pregnant during the course of the study.&#xD;
&#xD;
          -  Clinical laboratory values &lt; 2 times the upper limit of normal (ULN) or deemed not&#xD;
             clinically significant per the investigator and Naurex medical monitor&#xD;
&#xD;
          -  Ability to understand the requirements of the study, provide written informed consent,&#xD;
             abide by the study restrictions, and agree to return for the required assessments&#xD;
&#xD;
          -  Based on the investigator and Naurex medical monitor's clinical judgment, subjects&#xD;
             with eating disorders, obsessive compulsive disorder (OCD), panic disorder,&#xD;
             post-traumatic stress disorder (PTSD), and generalized anxiety disorders secondary to&#xD;
             major depressive episodes (MDEs) are permitted.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Axis I diagnosis of delirium, dementia, dysthymia, amnestic or other cognitive&#xD;
             disorder, schizophrenia or other psychotic disorder, bipolar I or II disorder, eating&#xD;
             disorder (anorexia or bulimia nervosa), obsessive-compulsive disorder, panic disorder,&#xD;
             acute stress disorder, agoraphobia, social phobia, attention-deficit hyperactivity&#xD;
             disorder (ADHD), or PTSD&#xD;
&#xD;
          -  A clinically significant current Axis II diagnosis of borderline, antisocial,&#xD;
             paranoid, schizoid, schizotypal, or histrionic personality disorder&#xD;
&#xD;
          -  Experiencing hallucinations, delusions, or any psychotic symptomatology in the current&#xD;
             episode; lifetime history of psychosis&#xD;
&#xD;
          -  Huntington's, Parkinson's, Alzheimer's, Multiple Sclerosis, or a history of seizures&#xD;
             or strokes&#xD;
&#xD;
          -  Currently hospitalized or residing in an in-patient facility during the study&#xD;
             participation&#xD;
&#xD;
          -  Substance abuse within the last 12 months&#xD;
&#xD;
          -  Women who are planning to become pregnant during the course of the study&#xD;
&#xD;
          -  Allergy or intolerance to current antidepressant or other current medications&#xD;
&#xD;
          -  Participation in any clinical trial of an investigational product or device within 30&#xD;
             days of enrollment in this trial with the exception of GLYX13-C-201.&#xD;
&#xD;
          -  Positive screen for drugs of abuse&#xD;
&#xD;
          -  Have received electroconvulsive therapy, transcranial magnetic stimulation (TMS), or&#xD;
             vagal nerve stimulation (VNS) for the current depressive episode&#xD;
&#xD;
          -  Pose current (past 6 months) suicide risk based on administration of the C SSRS and&#xD;
             the investigator's clinical judgment&#xD;
&#xD;
          -  Human immunodeficiency virus (HIV) infection (based on the HIV-1 &amp; HIV-2 antibody&#xD;
             screen) or other ongoing infectious disease&#xD;
&#xD;
          -  Females who are currently pregnant or planning to become pregnant during the course of&#xD;
             the study&#xD;
&#xD;
          -  Dextromethorphan or tramadol since these are serotonin uptake inhibitors&#xD;
&#xD;
          -  History of allergy, sensitivity, or intolerance to N-methyl-D-aspartate receptor&#xD;
             [NMDAR] ligands&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Naurex Inc, an affilate of Allergan plc</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Alabama Office of Psychiatric Clinical Research</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35294</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pharmacology Research Institute</name>
      <address>
        <city>Encino</city>
        <state>California</state>
        <zip>91316</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pharmacology Research Institute</name>
      <address>
        <city>Los Alamitos</city>
        <state>California</state>
        <zip>90720</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pacific Institute of Medical Research</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pharmacology Research Institute</name>
      <address>
        <city>Newport Beach</city>
        <state>California</state>
        <zip>92660</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Artemis Institute for Clinical Research</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sarkis Clinical Trials</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Atlanta Center for Medical Research</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30308</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Atlanta Institute of Medicine and Research</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30328</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chicago Research Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60634</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Evanston Premier Healthcare Research, LLC</name>
      <address>
        <city>Northbrook</city>
        <state>Illinois</state>
        <zip>60201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Indiana University Health Neuroscience Center</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Kansas</name>
      <address>
        <city>Wichita</city>
        <state>Kansas</state>
        <zip>67211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PharmaSite Research , Inc.</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bostin Clinical Trials, Inc.</name>
      <address>
        <city>Roslindale</city>
        <state>Massachusetts</state>
        <zip>02131</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CRI Lifetree</name>
      <address>
        <city>Marlton</city>
        <state>New Jersey</state>
        <zip>08054</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Global Medical Institutes LLC</name>
      <address>
        <city>Princeton</city>
        <state>New Jersey</state>
        <zip>08540</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinilabs, Inc.</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10019</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Michael R Liebowitz MD</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10128</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Finger Lake Clinical Research</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14618</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Summit Research Network (Oregon), Inc.</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lehigh Center for Clinical Research</name>
      <address>
        <city>Allentown</city>
        <state>Pennsylvania</state>
        <zip>18104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CRI Lifetree</name>
      <address>
        <city>Phildadelphia</city>
        <state>Pennsylvania</state>
        <zip>19139</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas Southwestern Medical Center of Dallas</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75235</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CRI Lifetree</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Summit Research Network</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2016</verification_date>
  <study_first_submitted>September 10, 2012</study_first_submitted>
  <study_first_submitted_qc>September 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2012</study_first_posted>
  <disposition_first_submitted>February 18, 2016</disposition_first_submitted>
  <disposition_first_submitted_qc>February 18, 2016</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">March 17, 2016</disposition_first_posted>
  <last_update_submitted>February 18, 2016</last_update_submitted>
  <last_update_submitted_qc>February 18, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 17, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>depression</keyword>
  <keyword>MDD</keyword>
  <keyword>GLYX-13</keyword>
  <keyword>HDRS-17</keyword>
  <keyword>HAMD-17</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depressive Disorder</mesh_term>
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder, Major</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted, but a results disposition has been submitted           -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01684163
org study id: GLYX13-C-202
nct id: NCT01684163
lead sponsor: 
has dmc: No
GLYX-13 is a NMDA receptor glycine site partial agonist being studied in subjects with major
      depressive disorder (depression) who have responded inadequately to another antidepressant
      drug during the current episode. This trial will assess the effects of GLYX-13 on depression
      when added to another antidepressant drug that the patient is already taking.
To evaluate the mean difference in Hamilton Depression Rating Scale 17 (HDRS-17) score for
      the combined GLYX-13 mean change versus the placebo group mean change at the end of a 6 week
      randomized withdrawal phase (predose baseline score - score at end of randomized withdrawal
      period).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change in Hamilton Depression Rating Scale Score
time frame: 6 weeks, 12 weeks, 16 weeks
measure: Clinical Global Impression of Change
time frame: 6 weeks, 12 weeks, 16 weeks
arm group label: Placebo injection
arm group type: Placebo Comparator
description: Normal saline
arm group label: GLYX-13, 5 mg/kg
arm group type: Experimental
description: Low dose of GLYX-13
arm group label: GLYX-13, 10 mg/kg
arm group type: Experimental
description: High dose of GLYX-13
intervention type: Drug
intervention name: GLYX-13 5 mg/kg
description: Intravenous administration of 5 mg/kg into arm.
arm group label: GLYX-13, 5 mg/kg
other name: GLYX-13 IV Dose
intervention type: Drug
intervention name: GLYX-13 10 mg/kg
description: Intravenous administration of 10 mg/kg into arm.
arm group label: GLYX-13, 10 mg/kg
other name: GLYX-13 IV Dose
intervention type: Drug
intervention name: Placebo
description: Intravenous administration of normal saline into arm.
arm group label: Placebo injection
other name: Normal Saline
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Medical Director
role: Study Director
affiliation: Naurex Inc, an affilate of Allergan plc
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country: United States
responsible party type: Sponsor
mesh term: Depressive Disorder
mesh term: Depression
mesh term: Depressive Disorder, Major