Clinical Trial: Fluoxetine vs EMDR to Treat Post-Traumatic Stress Disorder (PTSD)

This study has been completed.

Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)

Purpose

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.

Condition Treatment or Intervention Phase
Stress Disorders, Post-Traumatic
 Drug: Fluoxetine
 Behavior: EMDR
Phase III

MedlinePlus related topics:  Post-Traumatic Stress Disorder

Study Type: Interventional
Study Design: Treatment, Randomized

Official Title: Treatment of Outcomes of Fluoxetine vs EMDR in PTSD

Further Study Details: 

Study start: January 1999;  Study completion: December 2003

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.

Eligibility

Ages Eligible for Study:  18 Years   -   65 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

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


    Location Information


    Massachusetts
          The Trauma Center, Brookline,  Massachusetts,  02446,  United States

    Study chairs or principal investigators

    Bessel Van Der Kolk, MD,  Principal Investigator

    More Information

    Study ID Numbers:  MH58363
    Record last reviewed:  August 2004
    Last Updated:  October 13, 2004
    Record first received:  November 2, 1999
    ClinicalTrials.gov Identifier:  NCT00000379
    Health Authority: United States: Federal Government
    ClinicalTrials.gov processed this record on 2005-04-08


    Source: ClinicalTrials.gov
    Cache Date: April 9, 2005

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