Ketamine as a Rapid Treatment for Post-traumatic Stress Disorder (PTSD)
Condition: Stress Disorders, Post-Traumatic; PTSD; Depression; Anxiety Disorder
MeSH terms: Depression; Stress Disorders, Traumatic; Anxiety Disorders; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of the proposed study is to test if a single IV dose of ketamine (0.5 mg/kg)
      decreases symptoms of PTSD.
    

Detailed description: 
      PTSD is a debilitating anxiety disorder characterized by intrusive re-experiences of the
      traumatic events, avoidance of situations and stimuli that could serve as reminders of these
      events, and feeling jumpy or easily startled. Patients with PTSD are often also depressed,
      and many have significant memory impairments. Existing drug treatments are unsuccessful in a
      majority of patients, especially in those with combat-related PTSD.

      Our aim is to test the effectiveness of a potential new drug for PTSD, ketamine. For many
      years, intravenous ketamine has been extensively used for anesthesia. More recently, using
      doses lower than those used in anesthesia, a single ketamine infusion was shown to rapidly
      reduce depressed mood as well as anxiety in patients with severe depression. Some clinical
      evidence of potential efficacy in depressed patients with co-morbid PTSD also exists.

      Adverse effects in these studies have been limited to feeling intoxicated and having
      increased blood pressure during the infusion.

      In the present study, we expect a single ketamine infusion to reduce core PTSD symptoms. In
      addition, in those patients with PTSD who are depressed, we expect ketamine to reduce
      depressed mood.

      Finally, ketamine is known to impair memory function temporarily. We will also test if the
      extent of ketamine-induced memory impairment during the infusion can predict how well people
      do after the infusion. Forty patients with PTSD (with and without combat-related trauma
      histories) will be tested, using a design that will compare the effectiveness of intravenous
      ketamine to that of midazolam, another anesthetic drug without any known long-term effects on
      anxiety, depressed mood, and memory function. If ketamine is found to have the expected
      effects, future studies may explore additional benefits of repeated infusions and / or
      alternatives to intravenous drug administration. Our study may contribute to improved
      function of patients with PTSD by providing a new means to rapidly treat their debilitating
      symptoms.
    

Intervention name(s): Midazolam; Ketamine
Intervention type(s): Drug; Drug
Intervention description(s): single dose 0.045 mg/kg IV infused over 40 minutes; Single dose 0.5 mg/kg IV (in the vein) infused over 40 minutes
Other intervention name(s): Racemic ketamine hydrochloride
Intervention MeSH terms: Midazolam; Ketamine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Stress Disorders, Post-Traumatic; PTSD; anxiety disorder; ketamine; depression; depressed mood