NCT00000379

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jan 1999

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1999

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 3, 1999

Completed
4.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2003

Completed
Last Updated

February 20, 2014

Status Verified

February 1, 2014

First QC Date

November 2, 1999

Last Update Submit

February 19, 2014

Conditions

Stress Disorders, Post-Traumatic

Keywords

AdultComparative StudyDesensitization, PsychologicEye MovementsFemaleFluoxetineHumanMalePlacebosStress Disorders, Post-TraumaticTreatment OutcomeDesensitization, Psychologic -- *methodsFluoxetine -- *therapeutic useStress Disorders, Post-Traumatic -- *therapyStress Disorders, Post-Traumatic -- drug therapy

Interventions

FluoxetineDRUG
EMDRBEHAVIORAL

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Trauma Center

Brookline, Massachusetts, 02446, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticStress Disorders, Traumatic

Interventions

FluoxetineEye Movement Desensitization Reprocessing

Condition Hierarchy (Ancestors)

Trauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic ChemicalsDesensitization, PsychologicBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Bessel Van Der Kolk, MD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 2, 1999

First Posted

November 3, 1999

Study Start

January 1, 1999

Study Completion

December 1, 2003

Last Updated

February 20, 2014

Record last verified: 2014-02

Locations

US(1)