Clinical TrialTreatment-Resistant Depression (TRD)KetaminePlaceboKetamineCompleted

Research Study for Major Depressive Disorder: Investigation of Glutamate Medications

This randomised, double-blind, placebo-controlled trial (n=26) aims to investigate the safety and efficacy of ketamine and riluzole in patients with treatment-resistant major depressive disorder. Additionally, the study will assess whether lamotrigine can mitigate ketamine-associated side effects.

Target Enrollment
26 participants
Study Type
Phase IV interventional
Design
Randomized, triple Blind

Detailed Description

Randomised, double‑blind, factorial study (n=26) evaluating whether lamotrigine pre‑treatment (300 mg, 2 h prior) modifies acute response to a single IV subanesthetic racemic ketamine infusion in treatment‑resistant major depressive disorder; responders entered a 4‑week randomized continuation to riluzole 100 mg/day or placebo.

Primary outcomes include safety and efficacy measures; design includes a pre‑treatment (lamotrigine vs placebo) and a continuation phase (riluzole vs matching placebo) in ketamine responders.

Study Protocol

Preparation

sessions

Dosing

1 sessions

Integration

sessions

Study Arms & Interventions

Lamotrigine pre-treatment

experimental

Lamotrigine 300 mg given 2 h prior to ketamine; responders randomised to riluzole or placebo for 4 weeks.

Interventions

  • Compound300 mg
    via Oral• single dose

    Lamotrigine 300 mg given 2 hours prior to ketamine.

  • Ketamine
    via IV• single dose

    Single subanesthetic IV racemic ketamine (infusion details not specified).

  • Compound100 mg
    via Oral• daily (4 weeks)

    Riluzole 100 mg/day (two 50 mg capsules) given in the 4-week continuation phase for responders; randomised vs matching placebo.

Placebo pre-treatment

inactive

Placebo pre-treatment 2 h prior to ketamine; responders randomised to riluzole or placebo for 4 weeks.

Interventions

  • Placebo
    via Oral• single dose

    Three capsules matching lamotrigine given 2 hours prior to ketamine.

  • Ketamine
    via IV• single dose

    Single subanesthetic IV racemic ketamine (infusion details not specified).

  • Compound100 mg
    via Oral• daily (4 weeks)

    Riluzole 100 mg/day (two 50 mg capsules) given in the 4-week continuation phase for responders; randomised vs matching placebo.

Participants

Ages
21 – 70
Sexes
Male & Female

Inclusion Criteria

  • 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

  • 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

Study Details

Locations

Mount Sinai School of Medicine — New York, New York, United States

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