Ketamine Plus Lithium in Treatment-Resistant Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Treatment-Resistant
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to test the antidepressant effect of ketamine when given
      repeatedly over a period of 1 week, as well as the use of Lithium as a relapse-prevention
      strategy for patients with treatment-resistant depression (TRD) who respond to an initial
      series of ketamine infusions. Ketamine is a Food and Drug Administration approved anesthetic
      (a drug used to produce loss of consciousness before and during surgery). Ketamine is not
      approved for the treatment of major depressive disorder and is considered experimental in
      this study. An additional purpose of this study is to research the effects of ketamine on
      brain function.

      You may qualify to take part in this research study because you have been diagnosed with
      major depressive disorder (MDD) and have not responded to past treatments.
    

Detailed description: 
      Major Depressive Disorder (MDD) is a disabling medical illness and current monoaminergic
      treatments are slow to act and possess only limited efficacy. In this context, the discovery
      that the glutamate NMDA receptor antagonist ketamine is rapidly antidepressant (onset of
      action within hours) -- even in patients suffering from treatment-resistant depression (TRD)
      -- has ignited tremendous enthusiasm among clinicians, scientists and patients alike. A
      critical obstacle to the translation of this discovery into a novel treatment, however, is
      the limited duration of action following a course of ketamine (e.g. 1-2 weeks). The current
      project will address this important gap in medical knowledge by testing a rational
      neuropharmacological strategy designed to optimize and sustain the rapid antidepressant
      effects of ketamine. Driven by the recent characterization of the molecular mechanisms
      underpinning the antidepressant and neuroplasticity effects of ketamine, we will test the
      combination of ketamine plus lithium in patients with TRD using a randomized, double blind,
      placebo-controlled design. The primary aims of the project are (1) to test the efficacy of
      lithium-plus-ketamine compared to placebo-plus-ketamine as an antidepressant combination
      strategy in TRD and (2) to gather data on the safety and tolerability of the
      lithium-plus-ketamine.
    

Intervention name(s): Lithium; Ketamine; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Subjects in this arm take 600-1200mg of Lithium pills at night for duration of the study.; Subjects in this arm take placebo pills at night for duration of the study.
Other intervention name(s): Lithium Carbonate Immediate Release
Intervention MeSH terms: Ketamine; Lithium Carbonate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Ketamine; glutamate; N-methyl-D-aspartate; depression; major depressive disorder; treatment resistant; antidepressant; lithium