Ignite Creation Date:
2024-05-05 @ 10:22 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000379
Status:
COMPLETED
Last Update Posted:
2014-02-20
First Post:
1999-11-02
Brief Title:
Fluoxetine vs EMDR to Treat Post-Traumatic Stress Disorder PTSD
Sponsor:
Boston University
Organization:
Boston University
Study Overview
Official Title:
Treatment of Outcomes of Fluoxetine vs EMDR in PTSD
Status:
COMPLETED
Status Verified Date:
2014-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 himherself
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 heshe
Has PTSD and is 18 to 65 years old
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 heshe
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DSIR AT-CT | US NIH GrantContract | None | httpsreporternihgovquickSearchR01MH058363 |
| R01MH058363 | NIH | None | None |