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

NCT ID: NCT00000379

Last Updated: 2014-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-01-31
• Study Completion Date: 2003-12-31

Brief 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.

Conditions

Stress Disorders, Post-Traumatic

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: TREATMENT

Interventions

Fluoxetine

Intervention Type: DRUG

EMDR

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

-

Patients must have:

Post-Traumatic Stress Disorder (PTSD).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Boston University

OTHER

Sponsor Role: lead

Principal Investigators

Bessel Van Der Kolk, MD

Role: PRINCIPAL_INVESTIGATOR

Locations

The Trauma Center

Brookline, Massachusetts, United States

Countries

United States

Other Identifiers

R01MH058363

Identifier Type: NIH

Identifier Source: secondary_id

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DSIR AT-CT

Identifier Type: -

Identifier Source: secondary_id

R01MH058363

Identifier Type: NIH

Identifier Source: org_study_id

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