Reducing Suicidal Ideation Through Treatment of Nightmares-Post Traumatic Stress Disorder (PTSD)

Phase 4

Completed

• Conditions: Nightmares; Suicidal Ideation; Post Traumatic Stress Disorder
• Interventions: Drug: Placebo; Drug: Prazosin

• Registration Number: NCT02199652
• Lead Sponsor: Augusta University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-07-18
• Study First Submitted QC: 2014-07-23
• Study First Posted: 2014-07-24
• Primary Completion: 2017-09-01
• Study Completion: 2017-12-01
• Results First Submitted: 2018-06-26
• Results First Submitted QC: 2018-07-24
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-20
• Results First Posted: 2018-08-21
• Last Update Posted: 2018-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• PTSD
• Frequent nightmares
• Suicidality

Exclusion Criteria

• Schizophrenia
• Bipolar
• Substance abuse

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	Placebo	placebo pill
prazosin	Prazosin	prazosin pill

Primary Outcome Measures

Name	Time	Method
Change Score for Scale for Suicide Ideation	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

Secondary Outcome Measures

Name	Time	Method
Disturbing Dreams and Nightmare Severity Index	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	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"

Trial Locations

Locations (1)

Georgia Regents University; 🇺🇸 Augusta, Georgia, United States