Trial Outcomes & Findings for Reducing Suicidal Ideation Through Treatment of Nightmares-Post Traumatic Stress Disorder (PTSD) (NCT NCT02199652)

NCT ID: NCT02199652

Last Updated: 2018-09-18

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

20 participants

Primary outcome timeframe

change score from baseline to last observation, up to 8 weeks

Results posted on

2018-09-18

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo placebo pill Placebo	Prazosin prazosin pill Prazosin
Overall Study STARTED	10	10
Overall Study COMPLETED	3	3
Overall Study NOT COMPLETED	7	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=10 Participants placebo pill Placebo	Prazosin n=10 Participants prazosin pill Prazosin	Total n=20 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	43.2 years STANDARD_DEVIATION 12.7 • n=5 Participants	36.3 years STANDARD_DEVIATION 15.9 • n=7 Participants	39.8 years STANDARD_DEVIATION 14.5 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants	10 participants n=7 Participants	20 participants n=5 Participants

PRIMARY outcome

Timeframe: change score from baseline to last observation, up to 8 weeks

Outcome measures

Outcome measures
Measure	Placebo n=10 Participants placebo pill Placebo	Prazosin n=10 Participants prazosin pill Prazosin
Change Score for Scale for Suicide Ideation	7.6 units on a scale Standard Error 1.8	8.2 units on a scale Standard Error 1.9

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Placebo n=10 Participants placebo pill Placebo	Prazosin n=10 Participants prazosin pill Prazosin
Disturbing Dreams and Nightmare Severity Index	9.75 units on a scale Standard Error 1.7	15.8 units on a scale Standard Error 1.8

SECONDARY outcome

Timeframe: 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"

Outcome measures

Outcome measures
Measure	Placebo n=10 Participants placebo pill Placebo	Prazosin n=10 Participants prazosin pill Prazosin
Insomnia Severity Index	10.7 units on a scale Standard Error 1.2	15.4 units on a scale Standard Error 1.2

Adverse Events

Placebo

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Prazosin

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=10 participants at risk placebo pill Placebo	Prazosin n=10 participants at risk prazosin pill Prazosin
Psychiatric disorders psychiatric hospitalization	10.0% 1/10 • Number of events 1 • 8 weeks	10.0% 1/10 • Number of events 1 • 8 weeks

Other adverse events

Other adverse events
Measure	Placebo n=10 participants at risk placebo pill Placebo	Prazosin n=10 participants at risk prazosin pill Prazosin
Vascular disorders fainting	10.0% 1/10 • Number of events 1 • 8 weeks	20.0% 2/10 • Number of events 2 • 8 weeks

Additional Information

William Vaughn McCall

Medical College of Georgia; Augusta University

Phone: 7067216719

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place