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Research Study for Major Depressive Disorder: Investigation of Glutamate Medications

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ClinicalTrials.gov Identifier: NCT00419003
Recruitment Status : Completed
First Posted : January 5, 2007
Results First Posted : March 21, 2016
Last Update Posted : July 31, 2019
Sponsor:
Collaborators:
National Alliance for Research on Schizophrenia and Depression
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
Sanjay Johan Mathew, Baylor College of Medicine

Tracking Information
First Submitted Date  ICMJE January 4, 2007
First Posted Date  ICMJE January 5, 2007
Results First Submitted Date  ICMJE September 5, 2013
Results First Posted Date  ICMJE March 21, 2016
Last Update Posted Date July 31, 2019
Study Start Date  ICMJE December 2006
Actual Primary Completion Date July 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 19, 2016)
Montgomery-Asberg Depression Rating Scale (MARDS) Score (Acute Response to IV Ketamine in Patients With Treatment Resistant Major Depression) [ Time Frame: 24 Hours ]
Montgomery-Asberg Depression Rating Scale, each of the ten items can be scored from 0 (absence of symptoms to 6 most severe) and has a total score range of 0-60. A lower score on a MADRS indicates a less severe depression. The primary outcome for the initial phase of the trial was the 24-h MADRS score, which included all 10 MADRS items.
Original Primary Outcome Measures  ICMJE
 (submitted: January 4, 2007)
acute response to IV ketamine in patients with treatment resistant major depression (TRD)
Change History Complete list of historical versions of study NCT00419003 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: January 4, 2007)
efficacy of Lamotrigine, a glutamate-release inhibiting medication FDA-approved for bipolar disorder, in decreasing IV ketamine psychotomimetic side effects
Current Other Pre-specified Outcome Measures
 (submitted: July 16, 2019)
Efficacy of Lamotrigine in Decreasing IV Ketamine Psychotomimetic Side Effects [ Time Frame: 24, 48, or 72-hrs ]
Response rate and side effect differences to IV ketamine infusion based on lamotrigine and placebo pretreatment groups
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Research Study for Major Depressive Disorder: Investigation of Glutamate Medications
Official Title  ICMJE Continuation Riluzole in the Prevention of Relapse Following Ketamine in Major Depression
Brief Summary This study is examining the safety and effectiveness of two medications, ketamine and riluzole, in treating patients with treatment resistant major depressive disorder. This study will also examine the effectiveness of an FDA approved drug called lamotrigine in decreasing the potential side effects associated with ketamine.
Detailed Description This research proposal will investigate a glutamate-modulating agent, riluzole, in treatment-resistant patients who exhibit an acute, sustained response to a single dose of intravenous (IV) racemic ketamine. Fifty ketamine-responders will be randomized to riluzole or placebo in a 4-week, randomized, double-blind, continuation-phase study.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Major Depression
Intervention  ICMJE
  • Drug: Lamotrigine
    anticonvulsant medication
    Other Name: lamictal
  • Drug: Ketamine
    subanesthetic dose of NMDAR antagonist
    Other Name: ketalar
  • Drug: Riluzole
    glutamate release inhibitor
    Other Name: rilutek
Study Arms  ICMJE
  • Experimental: Lamotrigine Pre-Treatment
    Patients who met enrolment criteria for phase 1 were randomly allocated to lamotrigine or placebo by a permuted block procedure consisting of blocks of two or four patients. The randomization list was created by a biostatistician with no patient contact. 300 mg of lamotrigine 2 hrs prior to ketamine infusion. Responders were randomized to one of two continuation pharmacotherapy groups, receiving either two capsules of riluzole 50 mg each (100 mg/d) or matching pill placebo under double-blind conditions.
    Interventions:
    • Drug: Lamotrigine
    • Drug: Ketamine
    • Drug: Riluzole
  • Placebo Comparator: Placebo Pre-Treatment
    2 hours prior to ketamine infusion each patient received three capsules of placebo identical in size, weight, appearance, and taste to the lamotrigine tablets. Responders were randomized to one of two continuation pharmacotherapy groups, receiving either two capsules of riluzole 50 mg each (100 mg/d) or matching pill placebo under double-blind conditions.
    Interventions:
    • Drug: Ketamine
    • Drug: Riluzole
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 10, 2009)
26
Original Enrollment  ICMJE
 (submitted: January 4, 2007)
100
Actual Study Completion Date  ICMJE September 2008
Actual Primary Completion Date July 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male or female patients, 21- 70 years of age
  2. Subjects have a history of at least one previous episode of depression prior to the current episode (recurrent major depressive disorder) or have chronic major depressive disorder (at least two years' duration)
  3. Subjects have not responded to an adequate trial of one antidepressant in the current episode

Exclusion Criteria:

  1. Female subjects who are either pregnant or nursing
  2. Serious, unstable illnesses
  3. Any previous use or treatment with ketamine, or riluzole
  4. Past intolerance to lamotrigine, including drug rash
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00419003
Other Study ID Numbers  ICMJE 05-0850
5M01RR000071-46 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Sanjay Johan Mathew, Baylor College of Medicine
Study Sponsor  ICMJE Baylor College of Medicine
Collaborators  ICMJE
  • National Alliance for Research on Schizophrenia and Depression
  • National Center for Research Resources (NCRR)
Investigators  ICMJE
Principal Investigator: Sanjay Mathew, MD Baylor College of Medicine
PRS Account Baylor College of Medicine
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP