Research Study for Major Depressive Disorder: Investigation of Glutamate Medications

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2008-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Major Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Lamotrigine

Intervention Type DRUG

anticonvulsant medication

Ketamine

Intervention Type DRUG

subanesthetic dose of NMDAR antagonist

Riluzole

Intervention Type DRUG

glutamate release inhibitor

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.

Group Type PLACEBO_COMPARATOR

Ketamine

Intervention Type DRUG

subanesthetic dose of NMDAR antagonist

Riluzole

Intervention Type DRUG

glutamate release inhibitor

Interventions

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Lamotrigine

anticonvulsant medication

Intervention Type DRUG

Ketamine

subanesthetic dose of NMDAR antagonist

Intervention Type DRUG

Riluzole

glutamate release inhibitor

Intervention Type DRUG

Other Intervention Names

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lamictal ketalar rilutek

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No