Ketamine Infusions for PTSD and Treatment-Resistant Depression
Condition: Depressive Disorder, Treatment-Resistant; Stress Disorders, Post-Traumatic
MeSH terms: Depression; Depressive Disorder; Stress Disorders, Traumatic; Depressive Disorder, Treatment-Resistant; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 1

Summary: 
      The relationship between depression and trauma is well established. Co-occuring depression
      and post-traumatic stress disorder (PTSD) are associated with more severe symptoms and lower
      levels of functioning. Veterans with both depression and PTSD have been shown to be at much
      higher risk of suicide than individuals with only one of these disorders. Ketamine has been
      shown to have rapid antidepressant effects and also therapeutic action over PTSD symptoms.
      The purpose of this study is to see whether ketamine, when given as repeated infusions, can
      produce quick and sustained improvement in depression and PTSD symptoms for individuals who
      have not had their symptoms effectively treated by current treatments.
    

Detailed description: 
      The proposed study is a pilot study designed to determine the efficacy and safety of serial
      ketamine infusions among veterans with treatment-resistant depression (TRD) as well as
      chronic post-traumatic stress disorder (PTSD). The investigators hypothesize that six
      infusions of ketamine will be effective in decreasing severity of depressive symptoms and
      maintaining response.

      Participants will be male/female veterans (18 to 75 years old) of any era or military
      background who suffer from TRD and chronic PTSD. Potential participants will be recruited
      from Mental Health clinics and screened for eligibility using a two stage process
      (phone/chart review, followed by interview). Participants will receive six ketamine infusions
      on a Monday-Wednesday-Friday schedule over 2 weeks. On the day of infusion, participants will
      be required to stay at the clinical site for 3 hours after the medication has been given.
      Follow-up visits will occur at different time points over the course of 2 months after the
      two week infusion period has been completed.
    

Intervention name(s): Ketamine
Intervention type(s): Drug
Intervention description(s): Six infusions of 0.5 mg/Kg of ketamine hydrochloride solution over 2 weeks.
Intervention MeSH terms: Ketamine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ketamine; stress disorders, post-traumatic; stress disorders, traumatic; anxiety disorders; mental disorders; adjuvants, anesthesia; analgesics; anesthetics; anesthetics, dissociative; anesthetics, general; anesthetics, intravenous; excitatory amino acid agents; excitatory amino acid antagonists; hypnotics and sedatives; molecular mechanisms of pharmacological action; neurotransmitter agents; peripheral nervous system agents; pharmacologic actions; physiological effects of drugs; psychotropic drugs; sensory system agents; central nervous system agents; central nervous system depressants; depression; depressive disorder; depressive disorder, treatment-resistant; behavioral symptoms; mood disorders; therapeutic uses