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

August 20, 2018 updated by: Augusta University

Reducing Suicidal Ideation Through Treatment of Nightmares-PTSD

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Georgia Regents University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • PTSD
  • Frequent nightmares
  • Suicidality

Exclusion Criteria:

  • Schizophrenia
  • Bipolar
  • Substance abuse

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
placebo pill
Drug: Placebo
Experimental: prazosin
prazosin pill
Drug: Prazosin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
change score from baseline to last observation, up to 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
8 weeks
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"
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Augusta University

Investigators

  • Principal Investigator: William V McCall, MD, MS, Augusta University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2014

Primary Completion (Actual)

September 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

July 18, 2014

First Submitted That Met QC Criteria

July 23, 2014

First Posted (Estimate)

July 24, 2014

Study Record Updates

Last Update Posted (Actual)

September 18, 2018

Last Update Submitted That Met QC Criteria

August 20, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00001365

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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