Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00183430
Status:
TERMINATED
Last Update Posted:
2018-06-14
First Post:
2005-09-13
Brief Title:
Prazosin for Treating Noncombat Trauma Post-Traumatic Stress Disorder
Sponsor:
Seattle Institute for Biomedical and Clinical Research
Organization:
Seattle Institute for Biomedical and Clinical Research
Study Overview
Official Title:
Prazosin for Noncombat Trauma PTSD
Status:
TERMINATED
Status Verified Date:
2018-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Insufficient Enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will evaluate the effectiveness of prazosin in treating post-traumatic stress disorder caused by noncombat trauma in individuals taking selective serotonin reuptake inhibitors
Detailed Description:
Post-traumatic stress disorder PTSD is an anxiety disorder that can develop after exposure to a terrifying event in which grave physical harm occurred or was threatened People with PTSD have persistent frightening thoughts and memories of their past ordeal and often feel emotionally numb especially with people to whom they were once close PTSD was first recognized in male combat veterans Today however the majority of people who have PTSD are young women who have experienced non combat-related trauma such as sexual or physical assault or a life-threatening illness or accident The disorder can be short-lived but PTSD can also become chronic with long lasting symptoms that are often treatment-resistant possibly causing severe functional disability Frequent trauma-related nightmares and other debilitating sleep disruptions are examples of chronic PTSD symptoms for which an effective treatment has not been developed Sertraline and paroxetine both selective serotonin reuptake inhibitors SSRIs are the only drugs approved by the FDA for treating PTSD Neither of them however has been effective in reducing PTSD-related sleep disruption Studies have shown that the drug prazosin has been effective in reducing distressing trauma-related nightmares in older male combat veterans This study will evaluate the effectiveness of prazosin in treating post-traumatic stress disorder caused by noncombat trauma in individuals already being treated with SSRIs
Participants in this double-blind study will first undergo 12 weeks of treatment with psychotherapy and a standard SSRI After 12 weeks participants will be randomly assigned to receive either prazosin or placebo in addition to psychotherapy and standard SSRI treatment for a total of 8 weeks Study visits will occur weekly for the first 12 weeks and then at Weeks 1 2 4 6 and 8 during the 8-week phase Additionally follow-up visits will be held 4 and 18 weeks post-intervention PTSD symptoms disorder severity and frequency of sleep disturbances will be assessed
Participants in this double-blind study will first undergo 12 weeks of treatment with psychotherapy and a standard SSRI After 12 weeks participants will be randomly assigned to receive either prazosin or placebo in addition to psychotherapy and standard SSRI treatment for a total of 8 weeks Study visits will occur weekly for the first 12 weeks and then at Weeks 1 2 4 6 and 8 during the 8-week phase Additionally follow-up visits will be held 4 and 18 weeks post-intervention PTSD symptoms disorder severity and frequency of sleep disturbances will be assessed
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 |
|---|---|---|---|
| DATR AD-TS | US NIH GrantContract | None | httpsreporternihgovquickSearchR01MH069867 |
| R01MH069867 | NIH | None | None |