Reducing Suicidal Ideation Through Treatment of Nightmares-Post Traumatic Stress Disorder (PTSD) (REST-ON PTSD)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02199652|
Recruitment Status : Completed
First Posted : July 24, 2014
Results First Posted : August 21, 2018
Last Update Posted : September 18, 2018
|Condition or disease||Intervention/treatment||Phase|
|Post Traumatic Stress Disorder Suicidal Ideation Nightmares||Drug: Prazosin Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Reducing Suicidal Ideation Through Treatment of Nightmares-PTSD|
|Actual Study Start Date :||March 2014|
|Actual Primary Completion Date :||September 1, 2017|
|Actual Study Completion Date :||December 1, 2017|
Placebo Comparator: placebo
- Change Score for Scale for Suicide Ideation [ Time Frame: change score from baseline to last observation, up to 8 weeks ]
There will be data on the Scale for Suicide Ideation collected at the end of each week of treatment up to 8 weeks. Our apriori primary outcome is the change score in Scale for Suicide Ideation from baseline to the last observation.
This is a self report scale, with 19 items which measure present suicidality, each scored 0-2.
The total scale has a range from 0-38, with higher scores being worse
- Disturbing Dreams and Nightmare Severity Index [ Time Frame: 8 weeks ]This is a self report scale, with 5 items, producing a total score with a range from 0-37. Higher scores are worse. A score greater than 10 is considered to indicate a clinically relevant problem with nightmares and/or bad dreams
- Insomnia Severity Index [ Time Frame: 8 weeks ]
This is a self report scale, with 7 items scored 0-4, producing a total score range 0-28.
Higher scores are worse Score 0-7 is interpreted as "no insomnia problem" 8-14 "subclinical insomnia" 15-21 "moderate insomnia" 22-28 "severe insomnia"
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02199652
|United States, Georgia|
|Georgia Regents University|
|Augusta, Georgia, United States, 30912|
|Principal Investigator:||William V McCall, MD, MS||Augusta University|