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

• Sponsor: Augusta University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02199652
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Actual Duration (Months): 45
• Patients Per Site Per Month: 0.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Post Traumatic Stress Disorder; Suicidal Ideation; Nightmares	Drug: Prazosin; Drug: Placebo	Phase 4

Study Design

• Study Type: Interventional
• 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: Mar 1, 2014
• Actual Primary Completion Date: Sep 1, 2017
• Actual Study Completion Date: Dec 1, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change Score for Scale for Suicide Ideation [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 [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 [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"

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• PTSD

• Frequent nightmares

• Suicidality

Exclusion Criteria:

• Schizophrenia

• Bipolar

• Substance abuse

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Georgia Regents University	Augusta	Georgia	United States	30912

Sponsors and Collaborators

• Augusta University

Investigators

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

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Apr 6, 2015

More Information

Publications

None provided.

• Responsible Party: Augusta University
• ClinicalTrials.gov Identifier: NCT02199652
• Other Study ID Numbers: 00001365
• First Posted: Jul 24, 2014
• Last Update Posted: Sep 18, 2018
• Last Verified: Aug 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Suicidal Ideation; Prazosin

Study Results

Participant Flow

Arm/Group Title	Placebo	Prazosin
Arm/Group Description	placebo pill Placebo	prazosin pill Prazosin
Period Title: Overall Study
STARTED	10	10
COMPLETED	3	3
NOT COMPLETED	7	7

Baseline Characteristics

Arm/Group Title	Placebo	Prazosin	Total
Arm/Group Description	placebo pill Placebo	prazosin pill Prazosin	Total of all reporting groups
Overall Participants	10	10	20
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	10 100%	10 100%	20 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	43.2 (12.7)	36.3 (15.9)	39.8 (14.5)
Sex: Female, Male (Count of Participants)
Female	8 80%	9 90%	17 85%
Male	2 20%	1 10%	3 15%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	4 40%	2 20%	6 30%
White	6 60%	8 80%	14 70%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	10 100%	10 100%	20 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Prazosin
Arm/Group Description	placebo pill Placebo	prazosin pill Prazosin
Measure Participants	10	10
Least Squares Mean (Standard Error) [units on a scale]	7.6 (1.8)	8.2 (1.9)

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Prazosin
Arm/Group Description	placebo pill Placebo	prazosin pill Prazosin
Measure Participants	10	10
Least Squares Mean (Standard Error) [units on a scale]	9.75 (1.7)	15.8 (1.8)

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Prazosin
Arm/Group Description	placebo pill Placebo	prazosin pill Prazosin
Measure Participants	10	10
Least Squares Mean (Standard Error) [units on a scale]	10.7 (1.2)	15.4 (1.2)

Adverse Events

Time Frame	8 weeks
Arm/Group Title	Placebo		Prazosin
Arm/Group Description	placebo pill Placebo		prazosin pill Prazosin
All Cause Mortality
	Placebo		Prazosin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)
Serious Adverse Events
	Placebo		Prazosin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/10 (10%)		1/10 (10%)
Psychiatric disorders
psychiatric hospitalization	1/10 (10%)	1	1/10 (10%)	1
Other (Not Including Serious) Adverse Events
	Placebo		Prazosin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/10 (10%)		2/10 (20%)
Vascular disorders
fainting	1/10 (10%)	1	2/10 (20%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.