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

Primary Purpose

Post Traumatic Stress Disorder, Suicidal Ideation, Nightmares

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Prazosin
Placebo
Sponsored by
Augusta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Traumatic Stress Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • PTSD
  • Frequent nightmares
  • Suicidality

Exclusion Criteria:

  • Schizophrenia
  • Bipolar
  • Substance abuse

Sites / Locations

  • Georgia Regents University

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

placebo

prazosin

Arm Description

placebo pill

prazosin pill

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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"

Full Information

First Posted
July 18, 2014
Last Updated
August 20, 2018
Sponsor
Augusta University
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1. Study Identification

Unique Protocol Identification Number
NCT02199652
Brief Title
Reducing Suicidal Ideation Through Treatment of Nightmares-Post Traumatic Stress Disorder (PTSD)
Acronym
REST-ON PTSD
Official Title
Reducing Suicidal Ideation Through Treatment of Nightmares-PTSD
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
March 2014 (Actual)
Primary Completion Date
September 1, 2017 (Actual)
Study Completion Date
December 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Augusta University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Traumatic Stress Disorder, Suicidal Ideation, Nightmares

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebo pill
Arm Title
prazosin
Arm Type
Experimental
Arm Description
prazosin pill
Intervention Type
Drug
Intervention Name(s)
Prazosin
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change Score for Scale for Suicide Ideation
Description
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
Time Frame
change score from baseline to last observation, up to 8 weeks
Secondary Outcome Measure Information:
Title
Disturbing Dreams and Nightmare Severity Index
Description
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
Time Frame
8 weeks
Title
Insomnia Severity Index
Description
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"
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: PTSD Frequent nightmares Suicidality Exclusion Criteria: Schizophrenia Bipolar Substance abuse
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William V McCall, MD, MS
Organizational Affiliation
Augusta University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Georgia Regents University
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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