Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00202449
Status:
TERMINATED
Last Update Posted:
2018-07-10
First Post:
2005-09-12
Brief Title:
Prazosin vs Paroxetine in Combat Stress-Related Post-Traumatic Stress Disorder PTSD Nightmares Sleep Disturbance
Sponsor:
Seattle Institute for Biomedical and Clinical Research
Organization:
Seattle Institute for Biomedical and Clinical Research
Study Overview
Official Title:
A Placebo-Controlled Trial of Prazosin vs Paroxetine in Combat Stress-Related PTSD Nightmares and Sleep Disturbance
Status:
TERMINATED
Status Verified Date:
2018-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
recruitment difficulties
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purposes of this study are
to evaluate the efficacy and tolerability of the drug prazosin compared to placebo for combat stress-related nightmares sleep disturbance and overall function in recently combat-exposed returnees from Operation Iraqi Freedom OIF and Operation Enduring Freedom OEF
to evaluate the effects of the selective serotonin reuptake inhibitor SSRI paroxetine on behavioral symptoms and overall function in this population
to evaluate the efficacy and tolerability of the drug prazosin compared to placebo for combat stress-related nightmares sleep disturbance and overall function in recently combat-exposed returnees from Operation Iraqi Freedom OIF and Operation Enduring Freedom OEF
to evaluate the effects of the selective serotonin reuptake inhibitor SSRI paroxetine on behavioral symptoms and overall function in this population
Detailed Description:
Trauma-related nightmares and sleep disruption that follow combat exposure are distressing and frequently treatment resistant symptoms that impair quality of life and overall function These symptoms closely resemble core nighttime symptoms of posttraumatic stress disorder PTSD and are increasingly recognized in returnees from Operation Iraqi Freedom OIF and Operation Enduring Freedom OEF Prazosin a generically available brain active alpha-1 adrenergic receptor antagonist markedly reduced or eliminated combat trauma-related nightmares and sleep disruption in 23 of 25 combat-exposed returnees from OIF at Madigan Army Medical Center MAMC The use of prazosin in OIF returnees was based on clinical efficacy of prazosin for trauma-related nightmares sleep disturbance and overall function in Vietnam combat veterans with chronic PTSD The only drugs FDA approved for PTSD are the selective serotonin reuptake inhibitors SSRIs sertraline and paroxetine However SSRI effectiveness in combat trauma PTSD especially for nighttime symptoms remains questionable
This is a placebo-controlled clinical trial of prazosin vs the SSRI paroxetine for combat trauma-related nightmares sleep disturbance and overall posttraumatic stress disorder PTSD clinical severity in OIFOEF returnees Both neurobiologic considerations and our preliminary clinical treatment data provide support for the proposed trial Preclinical and clinical studies suggest a role for increased central nervous system CNS adrenergic outflow andor responsiveness in PTSD pathophysiology Possible mechanisms include alpha-1 adrenergic receptor-mediated effects on sleep physiology corticotropin releasing hormone secretion and disruption of cognitive processing
Here we propose a double-blind placebo-controlled parallel group 12 week clinical trial of prazosin vs paroxetine to test the following hypotheses
Hypothesis 1 Prazosin will be more effective than paroxetine or placebo for reducing frequency and intensity of combat trauma-related nightmares as measured by the distressing dreams item of the Clinician Administered PTSD Scale CAPS
Hypothesis 2 Prazosin will be more effective than paroxetine or placebo for improving sleep quality as measured by the Pittsburgh Sleep Quality Index PSQI
Hypothesis 3 Prazosin will be more effective than paroxetine or placebo for improving overall clinical status as measured by the Clinical Global Impression of Change CGIC
Hypothesis 4 Prazosin will be better tolerated than paroxetine as measured by days retained in the study and frequency of adverse events
Primary outcome measures will assess trauma-related nightmares sleep disturbance and change in global clinical status these will include the CAPS 59 Recurrent Distressing Dreams item the PSQI 60 and the CGIC 58 score Secondary outcome measures will include total CAPS score the CAPS subscale scores Reexperiencing Intrusions AvoidanceNumbing and Hyperarousal the Nightmare Frequency Questionnaire NFQ Insomnia Severity Index and measures of depressive signs and symptoms quality of life and number of study days completed
This is a placebo-controlled clinical trial of prazosin vs the SSRI paroxetine for combat trauma-related nightmares sleep disturbance and overall posttraumatic stress disorder PTSD clinical severity in OIFOEF returnees Both neurobiologic considerations and our preliminary clinical treatment data provide support for the proposed trial Preclinical and clinical studies suggest a role for increased central nervous system CNS adrenergic outflow andor responsiveness in PTSD pathophysiology Possible mechanisms include alpha-1 adrenergic receptor-mediated effects on sleep physiology corticotropin releasing hormone secretion and disruption of cognitive processing
Here we propose a double-blind placebo-controlled parallel group 12 week clinical trial of prazosin vs paroxetine to test the following hypotheses
Hypothesis 1 Prazosin will be more effective than paroxetine or placebo for reducing frequency and intensity of combat trauma-related nightmares as measured by the distressing dreams item of the Clinician Administered PTSD Scale CAPS
Hypothesis 2 Prazosin will be more effective than paroxetine or placebo for improving sleep quality as measured by the Pittsburgh Sleep Quality Index PSQI
Hypothesis 3 Prazosin will be more effective than paroxetine or placebo for improving overall clinical status as measured by the Clinical Global Impression of Change CGIC
Hypothesis 4 Prazosin will be better tolerated than paroxetine as measured by days retained in the study and frequency of adverse events
Primary outcome measures will assess trauma-related nightmares sleep disturbance and change in global clinical status these will include the CAPS 59 Recurrent Distressing Dreams item the PSQI 60 and the CGIC 58 score Secondary outcome measures will include total CAPS score the CAPS subscale scores Reexperiencing Intrusions AvoidanceNumbing and Hyperarousal the Nightmare Frequency Questionnaire NFQ Insomnia Severity Index and measures of depressive signs and symptoms quality of life and number of study days completed
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 |
|---|---|---|---|
| UW HS 04-1469-V 02 | OTHER | University of Washington | None |
| DoD PR054292 | OTHER_GRANT | None | None |