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.
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.
Patients must have:
Post-Traumatic Stress Disorder (PTSD).