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

Post Traumatic Stress Disorder Clinical Trial

— REST-ON PTSD  

Official title:

Reducing Suicidal Ideation Through Treatment of Nightmares-PTSD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02199652
• Other study ID #: 00001365
• Status: Completed
• Phase: Phase 4
• Start date: March 2014
• Est. completion date: December 1, 2017

Study information

• Verified date: August 2018
• Source: Augusta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Nightmares
• Post Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic
• Suicidal Ideation

Intervention

Drug:
• Prazosin

• Placebo

Locations

Country	Name	City	State
United States	Georgia Regents University	Augusta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Augusta University

Country where clinical trial is conducted

United States, 

Outcome

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