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Fluoxetine vs EMDR to Treat Post-Traumatic Stress Disorder (PTSD) Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about Fluoxetine vs EMDR to Treat Post-Traumatic Stress Disorder (PTSD) conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Fluoxetine vs EMDR to Treat Post-Traumatic Stress Disorder (PTSD) Clinical research trials and Fluoxetine vs EMDR to Treat Post-Traumatic Stress Disorder (PTSD) medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as Fluoxetine vs EMDR to Treat Post-Traumatic Stress Disorder (PTSD). Fluoxetine vs EMDR to Treat Post-Traumatic Stress Disorder (PTSD) Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Fluoxetine vs EMDR to Treat Post-Traumatic Stress Disorder (PTSD) clinical trial. Participants frequently get the best healthcare available for their Fluoxetine vs EMDR to Treat Post-Traumatic Stress Disorder (PTSD) condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "F" Clinical Trials Conditions > Fluoxetine vs EMDR to Treat Post-Traumatic Stress Disorder (PTSD)  Fluoxetine vs EMDR to Treat Post-Traumatic Stress Disorder (PTSD)
Fluoxetine vs EMDR to Treat Post-Traumatic Stress Disorder (PTSD)
For Condition: Stress Disorders, Post-Traumatic
Status: No longer recruiting
Sponsor(s): National Institute of Mental Health (NIMH) ,
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment, Randomized
Minimum Age/Maximum Age: 18 Years/65 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: Patients must have: Post-Traumatic Stress Disorder (PTSD).
Total Enrollment:
Location and Contact Information:
Overall Study Official:
BesselDer Kolk, Principal Investigator,
The Trauma Center
Brookline, Massachusetts, 02446
United States
Additional Information:
Study ID Numbers: MH58363;
Study Start Date: January 1999
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000379
Other Stress Disorders, Post-Traumatic Studies:
1. Treatment of Depression in Patients with PTSD
2. Fluoxetine vs EMDR to Treat Post-Traumatic Stress Disorder (PTSD)
3. Acupuncture for the Treatment of Post-Traumatic Stress Disorder (PTSD)
4. Brain Structure and Function Before and After Treatment for Post-Traumatic Stress Disorder
5. Clinical Trial of Cognitive Behavioral Treatment for Postraumatic Stress Disorder in Women Veterans
Related Studies:
Other Stress Disorders, Post-Traumatic Clinical Trials
Other Massachusetts Clinical Trials
Other Brookline Clinical Trials
Fluoxetine vs EMDR to Treat Post-Traumatic Stress Disorder (PTSD)
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