Research Study for Major Depressive Disorder: Investigation of Glutamate Medications
Major Depression
About this trial
This is an interventional treatment trial for Major Depression
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
Sites / Locations
- Mount Sinai School of Medicine
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Lamotrigine Pre-Treatment
Placebo 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.
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.