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Research Study for Major Depressive Disorder: Investigation of Glutamate Medications

Primary Purpose

Major Depression

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Lamotrigine
Ketamine
Riluzole
Sponsored by
Baylor College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depression

Eligibility Criteria

21 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mount Sinai School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lamotrigine Pre-Treatment

Placebo Pre-Treatment

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Montgomery-Asberg Depression Rating Scale (MARDS) Score (Acute Response to IV Ketamine in Patients With Treatment Resistant Major Depression)
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.

Secondary Outcome Measures

Full Information

First Posted
January 4, 2007
Last Updated
July 16, 2019
Sponsor
Baylor College of Medicine
Collaborators
National Alliance for Research on Schizophrenia and Depression, National Center for Research Resources (NCRR)
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1. Study Identification

Unique Protocol Identification Number
NCT00419003
Brief Title
Research Study for Major Depressive Disorder: Investigation of Glutamate Medications
Official Title
Continuation Riluzole in the Prevention of Relapse Following Ketamine in Major Depression
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor College of Medicine
Collaborators
National Alliance for Research on Schizophrenia and Depression, National Center for Research Resources (NCRR)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lamotrigine Pre-Treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo Pre-Treatment
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Lamotrigine
Other Intervention Name(s)
lamictal
Intervention Description
anticonvulsant medication
Intervention Type
Drug
Intervention Name(s)
Ketamine
Other Intervention Name(s)
ketalar
Intervention Description
subanesthetic dose of NMDAR antagonist
Intervention Type
Drug
Intervention Name(s)
Riluzole
Other Intervention Name(s)
rilutek
Intervention Description
glutamate release inhibitor
Primary Outcome Measure Information:
Title
Montgomery-Asberg Depression Rating Scale (MARDS) Score (Acute Response to IV Ketamine in Patients With Treatment Resistant Major Depression)
Description
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.
Time Frame
24 Hours
Other Pre-specified Outcome Measures:
Title
Efficacy of Lamotrigine in Decreasing IV Ketamine Psychotomimetic Side Effects
Description
Response rate and side effect differences to IV ketamine infusion based on lamotrigine and placebo pretreatment groups
Time Frame
24, 48, or 72-hrs

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female patients, 21- 70 years of age 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) Subjects have not responded to an adequate trial of one antidepressant in the current episode Exclusion Criteria: Female subjects who are either pregnant or nursing Serious, unstable illnesses Any previous use or treatment with ketamine, or riluzole Past intolerance to lamotrigine, including drug rash
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sanjay Mathew, MD
Organizational Affiliation
Baylor College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25271445
Citation
Wan LB, Levitch CF, Perez AM, Brallier JW, Iosifescu DV, Chang LC, Foulkes A, Mathew SJ, Charney DS, Murrough JW. Ketamine safety and tolerability in clinical trials for treatment-resistant depression. J Clin Psychiatry. 2015 Mar;76(3):247-52. doi: 10.4088/JCP.13m08852.
Results Reference
derived
PubMed Identifier
19545857
Citation
Price RB, Nock MK, Charney DS, Mathew SJ. Effects of intravenous ketamine on explicit and implicit measures of suicidality in treatment-resistant depression. Biol Psychiatry. 2009 Sep 1;66(5):522-6. doi: 10.1016/j.biopsych.2009.04.029. Epub 2009 Jul 9.
Results Reference
derived
PubMed Identifier
19288975
Citation
Mathew SJ, Murrough JW, aan het Rot M, Collins KA, Reich DL, Charney DS. Riluzole for relapse prevention following intravenous ketamine in treatment-resistant depression: a pilot randomized, placebo-controlled continuation trial. Int J Neuropsychopharmacol. 2010 Feb;13(1):71-82. doi: 10.1017/S1461145709000169. Epub 2009 Mar 17.
Results Reference
derived

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Research Study for Major Depressive Disorder: Investigation of Glutamate Medications

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