Nightmares, Post Traumatic Stress Disorder, Suicidal Ideation
Conditions
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.
Interventions
DRUGPrazosin
DRUGPlacebo
Sponsors
Augusta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* PTSD * Frequent nightmares * Suicidality
Exclusion criteria
* Schizophrenia * Bipolar * Substance abuse
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo placebo pill
Placebo | 10 |
| Prazosin prazosin pill
Prazosin | 10 |
| Total | 20 |
Baseline characteristics
| Characteristic | Prazosin | Total | Placebo |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 20 Participants | 10 Participants |
| Age, Continuous | 36.3 years STANDARD_DEVIATION 15.9 | 39.8 years STANDARD_DEVIATION 14.5 | 43.2 years STANDARD_DEVIATION 12.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 6 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 14 Participants | 6 Participants |
| Region of Enrollment United States | 10 participants | 20 participants | 10 participants |
| Sex: Female, Male Female | 9 Participants | 17 Participants | 8 Participants |
| Sex: Female, Male Male | 1 Participants | 3 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 1 / 10 | 2 / 10 |
| serious Total, serious adverse events | 1 / 10 | 1 / 10 |
Outcome results
Primary
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
Time frame: change score from baseline to last observation, up to 8 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change Score for Scale for Suicide Ideation | 7.6 units on a scale | Standard Error 1.8 |
| Prazosin | Change Score for Scale for Suicide Ideation | 8.2 units on a scale | Standard Error 1.9 |
Secondary
Disturbing Dreams and Nightmare Severity Index
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
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Disturbing Dreams and Nightmare Severity Index | 9.75 units on a scale | Standard Error 1.7 |
| Prazosin | Disturbing Dreams and Nightmare Severity Index | 15.8 units on a scale | Standard Error 1.8 |
Secondary
Insomnia Severity Index
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
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Insomnia Severity Index | 10.7 units on a scale | Standard Error 1.2 |
| Prazosin | Insomnia Severity Index | 15.4 units on a scale | Standard Error 1.2 |