Post Traumatic Stress Disorder Clinical Trial
— REST-ON PTSDOfficial title:
Reducing Suicidal Ideation Through Treatment of Nightmares-PTSD
Verified date | August 2018 |
Source | Augusta University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Patients with PTSD, and frequent nightmares, and mild-moderate suicidal ideation, who are already taking a Selective Serotonin Reuptake Inhibitor (SSRI) or Serotonin Norepinephrine Reuptake Inhibitor (SNRI) will be randomized to either prazosin or placebo. The investigators hypothesize that patients receiving prazosin will have a greater reduction in suicidal ideation.
Status | Completed |
Enrollment | 20 |
Est. completion date | December 1, 2017 |
Est. primary completion date | September 1, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - PTSD - Frequent nightmares - Suicidality Exclusion Criteria: - Schizophrenia - Bipolar - Substance abuse |
Country | Name | City | State |
---|---|---|---|
United States | Georgia Regents University | Augusta | Georgia |
Lead Sponsor | Collaborator |
---|---|
Augusta University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change Score for Scale for Suicide Ideation | 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 |
change score from baseline to last observation, up to 8 weeks | |
Secondary | Disturbing Dreams and Nightmare Severity Index | 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 | 8 weeks | |
Secondary | Insomnia Severity Index | 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" |
8 weeks |
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