Fluoxetine vs EMDR to Treat Post-Traumatic Stress Disorder (PTSD)
Condition: Stress Disorders, Post-Traumatic
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare two treatments for post-traumatic stress disorder
      (PTSD): fluoxetine (an antidepressant) and Eye Movement Desensitization and Reprocessing
      (EMDR, a psychological treatment in which the patient is led through the memory of a
      traumatic experience in order to heal him/herself).

      There are a variety of therapies used to treat PTSD, but the effectiveness of medication
      alone vs an exposure treatment, such as EMDR, has not been tested.

      Patients will be assigned randomly (like tossing a coin) to one of three groups for 8 weeks
      of treatment. Group 1 will receive fluoxetine; Group 2 will receive EMDR; and Group 3 will
      receive inactive placebo. Patients will then stop treatment and have evaluations, including
      psychological tests, at the time treatment is stopped, 8 weeks later, and at 6 months.

      An individual may be eligible for this study if he/she:

      Has PTSD and is 18 to 65 years old.
    

Detailed description: 
      To compare the short-term and long-term efficacy of two different treatment approaches in
      widespread use in clinical settings for treating patients with post-traumatic stress disorder
      (PTSD): fluoxetine (which acts directly on biological systems) vs a psychological treatment,
      Eye Movement Desensitization and Reprocessing (EMDR). To clarify: 1) the differential
      treatment effects of these different treatment modalities; 2) whether symptom improvement is
      accompanied by changes in pathophysiology; and 3) the long-term effectiveness of these
      treatments.

      In recent years a variety of treatment approaches have been shown to be effective in the
      treatment of PTSD. These include prolonged exposure therapies (PE), stress inoculation
      training (SIT), EMDR and psychopharmacological treatment with serotonin re-uptake blockers.
      While PE has been compared with SIT and a study is currently under way comparing
      cognitive-behavioral treatment with EMDR, no study as yet has compared the relative merits of
      pharmacotherapy alone vs an exposure treatment. While it is commonly held that, in order to
      recover, people with PTSD need to "process" their traumatic memories, treatments that do not
      involve the processing of traumatic memories (such as SIT or pharmacotherapy) may be just as
      effective. In clinical practice, many patients with PTSD appear to be effectively treated
      with pharmacological agents alone, without trauma-focused therapy.

      Patients are randomly assigned to one of three conditions: 1) a double-blind
      psychopharmacological treatment (fluoxetine); 2) a manualized treatment which focuses on
      "processing" traumatic memories (EMDR); or 3) a placebo control group. After 8 weeks of
      active treatment, subjects are evaluated, cease treatment, and are assessed again after
      another 8 weeks and at 6 months in order to evaluate the long-term effects. Training raters
      remain blind to the subjects' treatment condition throughout the study. Treatment outcome is
      assessed with a multi-modal psychological and biological assessment battery including: 1)
      standard psychological tests for PTSD (CAPS); 2) neuroendocrine function (cortisol); and 3)
      psychophysiological response to traumatic scripts (pre-post changes in heart social and
      occupational functioning). Treatment adherence is monitored throughout the study.
    

Intervention name(s): Fluoxetine; EMDR
Intervention type(s): Drug; Behavioral
Intervention MeSH terms: Fluoxetine
Allocation: Randomized
Primary purpose: Treatment
Keywords: Adult; Comparative Study; Desensitization, Psychologic; Eye Movements; Female; Fluoxetine; Human; Male; Placebos; Stress Disorders, Post-Traumatic; Treatment Outcome; Desensitization, Psychologic -- *methods; Fluoxetine -- *therapeutic use; Stress Disorders, Post-Traumatic -- *therapy; Stress Disorders, Post-Traumatic -- drug therapy