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OpenTrials
Completed

NCT Number: NCT02199652

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

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Key information

Conditions

Post Traumatic Stress Disorder Behavior Behavioral Symptoms Mental Disorders Nightmares Self-Injurious Behavior Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Suicidal Ideation Suicide Trauma and Stressor Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Georgia Regents University

Augusta, Georgia, 30912, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • PTSD
  • Frequent nightmares
  • Suicidality

Exclusion criteria

  • Schizophrenia
  • Bipolar
  • Substance abuse

Treatment and study plan

Prazosin

Drug

Placebo

Drug

Primary outcomes

  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 outcomes

  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"

Sponsors and collaborators

Lead sponsor

Augusta University

Other

Registry information

Official study title

Reducing Suicidal Ideation Through Treatment of Nightmares-PTSD

Acronym: REST-ON PTSD

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jul 24, 2014
Registry last updated
Sep 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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