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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02199652
Recruitment Status : Completed
First Posted : July 24, 2014
Results First Posted : August 21, 2018
Last Update Posted : September 18, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Post Traumatic Stress Disorder Suicidal Ideation Nightmares Drug: Prazosin Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Reducing Suicidal Ideation Through Treatment of Nightmares-PTSD
Actual Study Start Date : March 2014
Actual Primary Completion Date : September 1, 2017
Actual Study Completion Date : December 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide

Arm Intervention/treatment
Placebo Comparator: placebo
placebo pill
Drug: Placebo
Experimental: prazosin
prazosin pill
Drug: Prazosin



Primary Outcome Measures :
  1. 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



Secondary Outcome Measures :
  1. 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

  2. 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"




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • PTSD
  • Frequent nightmares
  • Suicidality

Exclusion Criteria:

  • Schizophrenia
  • Bipolar
  • Substance abuse

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02199652


Locations
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United States, Georgia
Georgia Regents University
Augusta, Georgia, United States, 30912
Sponsors and Collaborators
Augusta University
Investigators
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Principal Investigator: William V McCall, MD, MS Augusta University
  Study Documents (Full-Text)

Documents provided by Augusta University:
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Responsible Party: Augusta University
ClinicalTrials.gov Identifier: NCT02199652    
Other Study ID Numbers: 00001365
First Posted: July 24, 2014    Key Record Dates
Results First Posted: August 21, 2018
Last Update Posted: September 18, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Suicidal Ideation
Trauma and Stressor Related Disorders
Mental Disorders
Suicide
Self-Injurious Behavior
Behavioral Symptoms
Prazosin
Antihypertensive Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs