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

NCT02199652 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 00001365
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Traumatic Stress Disorder; Suicidal Ideation; Nightmares

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Disturbing Dreams and Nightmare Severity Index

  8 weeks

• Insomnia Severity Index

  8 weeks

Study Arms (2)

placebo

PLACEBO COMPARATOR

placebo pill

Drug: Placebo

prazosin

EXPERIMENTAL

prazosin pill

Drug: Prazosin

Interventions

Prazosin DRUG

prazosin

Placebo DRUG

placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• PTSD
• Frequent nightmares
• Suicidality

You may not qualify if:

• Schizophrenia
• Bipolar
• Substance abuse

Sponsors & Collaborators

• Augusta University: lead

Study Sites (1)

Georgia Regents University

Augusta, Georgia, 30912, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Suicidal Ideation

Interventions

Prazosin

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: William Vaughn McCall
• Organization: Medical College of Georgia; Augusta University

WMCCALL@augusta.edu

7067216719

Study Officials

• William V McCall, MD, MS

  Augusta University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2014
• First Posted: July 24, 2014
• Study Start: March 1, 2014
• Primary Completion: September 1, 2017
• Study Completion: December 1, 2017
• Last Updated: September 18, 2018
• Results First Posted: August 21, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)