prazosin and Suicidal Ideation studies

Prazosin: A selective adrenergic alpha-1 antagonist used in the treatment of HEART FAILURE; HYPERTENSION; PHEOCHROMOCYTOMA; RAYNAUD DISEASE; PROSTATIC HYPERTROPHY; and URINARY RETENTION.
prazosin : A member of the class of piperazines that is piperazine substituted by a furan-2-ylcarbonyl group and a 4-amino-6,7-dimethoxyquinazolin-2-yl group at positions 1 and 4 respectively.

Suicidal Ideation: A risk factor for suicide attempts and completions, it is the most common of all suicidal behavior, but only a minority of ideators engage in overt self-harm.

Research Excerpts

Excerpt	Relevance	Reference
"Ninety-three Veterans participating in a randomized, double-blind, placebo-controlled treatment study evaluating the efficacy of the alpha-adrenergic agonist prazosin completed measures assessing overt hostility, covert hostility, and suicidal ideation at baseline."	5.27	Suicidal ideation in military veterans with alcohol dependence and PTSD: The role of hostility. ( Gandelman, E; Kachadourian, LK; Petrakis, IL; Ralevski, E, 2018)
" However, nighttime measures of nightmares and insomnia showed significantly less improvement in the prazosin group, whereas there was no significant change in daytime measures of suicidal ideation and daytime-only PTSD symptoms."	5.27	A Pilot, Randomized Clinical Trial of Bedtime Doses of Prazosin Versus Placebo in Suicidal Posttraumatic Stress Disorder Patients With Nightmares. ( Branch, F; Case, D; McCall, WV; McCloud, L; Moraczewski, J; Nolla, T; Pandya, CD; Pillai, A; Rosenquist, PB; Tauhidul, L; Youssef, NA, 2018)

Research

Studies (3)

Authors

Clinical Trials (2)

Trial Overview

Trial Outcomes

CAPS Recurrent Distressing Dreams Item

Timeframe	Studies, this research(%)	All Research%
pre-1990	0 (0.00)	18.7374
1990's	0 (0.00)	18.2507
2000's	0 (0.00)	29.6817
2010's	3 (100.00)	24.3611
2020's	0 (0.00)	2.80

Authors	Studies
Raskind, MA	1
Peskind, ER	1
Chow, B	1
Harris, C	1
Davis-Karim, A	1
Holmes, HA	1
Hart, KL	1
McFall, M	1
Mellman, TA	1
Reist, C	1
Romesser, J	1
Rosenheck, R	1
Shih, MC	1
Stein, MB	1
Swift, R	1
Gleason, T	1
Lu, Y	1
Huang, GD	1
Kachadourian, LK	1
Gandelman, E	1
Ralevski, E	1
Petrakis, IL	1
McCall, WV	1
Pillai, A	1
Case, D	1
McCloud, L	1
Nolla, T	1
Branch, F	1
Youssef, NA	1
Moraczewski, J	1
Tauhidul, L	1
Pandya, CD	1
Rosenquist, PB	1

Trial	Phase	Enrollment	Study Type	Start Date	Status
Open Label 8-Week Study of Prazosin Use in Adults With Anxiety Disorders[NCT03894345]	Phase 1	20 participants (Anticipated)	Interventional	2019-05-24	Suspended (stopped due to COVID-19)
CSP #563 - Prazosin and Combat Trauma PTSD (PACT)[NCT00532493]	Phase 3	304 participants (Actual)	Interventional	2010-01-06	Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Change from baseline in frequency and/or severity of combat trauma-related nightmares will be assessed by the CAPS Recurrent Distressing Dreams item. Possible range for Recurrent Distressing Dreams is 0-8. Higher score indicates more severe PTSD symptoms. (NCT00532493)
Timeframe: This primary outcome measure was administered at baseline and week 10. The change of the 10-week from baseline was reported.

Clinical Global Impression of Change (CGIC)

Intervention	scores on a scale (Mean)
Prazosin Group	-1.9
Placebo Group	-1.7

Change from baseline in possible range for Clinical Global Impression of Change 1-7. As compared to baseline global condition, 1 is marked improvement, 2 is moderate improvement, 3 is minimal improvement, 4 is no change, 5 is minimal worsening, 6 is moderate worsening, and 7 is marked worsening. (NCT00532493)
Timeframe: This primary outcome measure was administered at baseline and week 10. The change of the 10-week from baseline was reported.

Pittsburgh Sleep Quality Index (PSQI)

Intervention	scores on a scale (Mean)
Prazosin	3.3
Placebo	3.3

Change from baseline in possible range for PSQI global score 0-21. Higher PSQI score indicates worse quality of sleep. (NCT00532493)
Timeframe: This primary outcome measure was administered at baseline and week 10. The change of the 10-week from baseline was reported.

Alcohol Use Disorders Identification Test-Consumption (AUDIT-C)

Intervention	scores on a scale (Mean)
Prazosin	-2.3
Placebo	-2.1

Change from baseline in possible range for Audit-C score is 0-12. Higher score indicates heavier use of alcohol. A score of >=4 for male and a score of >=3 for female meets the criteria for alcohol use disorders. (NCT00532493)
Timeframe: This secondary outcome measure was administered at baseline, 6, 10, 14, 18, 22 and 26 weeks (or early termination).

CAPS Recurrent Distressing Dreams Item

Intervention	scores on a scale (Mean)
	Baseline	Change at Week 6	Change at Week 10	Change at Week 14	Change at Week 18	Change at Week 22	Change at Week 26
Placebo	2.2	-0.3	-0.2	-0.4	-0.1	-0.3	-0.3
Prazosin	2	-0.3	-0.4	-0.2	-0.2	-0.2	-0.3

Change from baseline in frequency and/or severity of combat trauma-related nightmares will be assessed by the CAPS Recurrent Distressing Dreams item. Possible range for Recurrent Distressing Dreams is 0-8. Higher score indicates more severe PTSD symptoms. (NCT00532493)
Timeframe: This secondary outcome measure was administered at baseline, 6, 10, 14, 18, 22 and 26 weeks (or early termination) to assess temporal course of changes in symptoms in response to prazosin or placebo.

Clinical Global Impression of Change

Intervention	scores on a scale (Mean)
	Baseline	Change at Week 6	Change at Week 10	Change at Week 14	Change at Week 18	Change at Week 22	Change at Week 26
Placebo Group	6.3	-1.4	-1.7	-2.5	-2.4	-2.5	-2.2
Prazosin Group	6.3	-1.3	-1.9	-2.2	-1.8	-2.4	-2.3

Change from baseline in possible range for Clinical Global Impression of Change (CGIC) 1-7. As compared to baseline global condition, 1 is marked improvement, 2 is moderate improvement, 3 is minimal improvement, 4 is no change, 5 is minimal worsening, 6 is moderate worsening, and 7 is marked worsening. (NCT00532493)
Timeframe: This secondary outcome measure was administered at 6, 10, 14, 18, 22 and 26 weeks (or early termination).

Patient Health Questionnaire-9 (PHQ9)

Intervention	scores on a scale (Mean)
	Week 6	Week 10	Week 14	Week 18	Week 22	Week 26
Placebo	3.3	3.3	3	3	2.9	2.9
Prazosin	3.2	3.3	3	3.2	2.9	2.9

Change from baseline in possible range for PHQ9 score is 0-27. Higher PHQ9 score indicates more severe depression. (NCT00532493)
Timeframe: This secondary outcome measure was administered at baseline, 6, 10, 14, 18, 22 and 26 weeks (or early termination).

Pittsburgh Sleep Quality Index

Intervention	scores on a scale (Mean)
	Baseline	Change at Week 6	Change at Week 10	Change at Week 14	Change at Week 18	Change at Week 22	Change at Week 26
Placebo	14.6	-2.8	-2.2	-2.6	-2.4	-2.5	-2.8
Prazosin	13.7	-1.6	-1.9	-1.9	-1.6	-2.2	-2

Change from baseline in possible range for PSQI global score 0-21. Higher PSQI score indicates worse quality of sleep. (NCT00532493)
Timeframe: This secondary outcome measure was administered at baseline, 6, 10, 14, 18, 22 and 26 weeks (or early termination).

PTSD Checklist-Military Version (PCL-M) Score

Intervention	scores on a scale (Mean)
	Baseline	Change at Week 6	Change at Week 10	Change at Week 14	Change at Week 18	Change at Week 22	Change at Week 26
Placebo	14.7	-2.4	-2.1	-2.7	-2.8	-2.7	-2.7
Prazosin	14.4	-2.1	-2.3	-3.1	-2.4	-2.9	-2.9

Change from baseline in possible range for PCL-M score 17-85. Higher PCL score indicates greater propensity for chronic and delayed PTSD. (NCT00532493)
Timeframe: This secondary outcome was administered at baseline, 6, 10, 14, 18, 22 and 26 weeks to assess change in PTSD symptom severity.

Quality of Life Inventory (QOLI)

Intervention	scores on a scale (Mean)
	Baseline	Change at Week 6	Change at Week 10	Change at Week 14	Change at Week 18	Change at Week 22	Change at Week 26
Placebo	64.3	-6.2	-5.8	-7.6	-8.4	-9.2	-9.7
Prazosin	62.5	-6.3	-7	-8.1	-7.2	-7.1	-8.2

Change from baseline in possible range for QOLI is -6 to 6. Higher QOLI indicates better satisfaction with life. (NCT00532493)
Timeframe: This secondary outcome measure was administered at baseline, 6, 10, 14, 18, 22 and 26 weeks (or early termination).

SF-12 Mental Standardized Score (SF-12 MCS)

Intervention	scores on a scale (Mean)
	Baseline	Change at Week 6	Change at Week 10	Change at Week 14	Change at Week 18	Change at Week 22	Change at Week 26
Placebo	0	0	0.1	0	0.1	0.1	0.2
Prazosin	0.1	0.1	0	0.1	0.3	0.1	0.2

Change from baseline in possible range for SF-12 MCS is 5-76. Higher SF-12 score indicates better level of health. (NCT00532493)
Timeframe: This secondary outcome measure was administered at baseline, 6, 10, 14, 18, 22 and 26 weeks (or early termination).

SF-12 Physical Standardized Score (SF-12 PCS)

Intervention	scores on a scale (Mean)
	Baseline	Change at Week 6	Change at Week 10	Change at Week 14	Change at Week 18	Change at Week 22	Change at Week 26
Placebo	39.4	-1.3	-1.1	-1	-0.7	-0.6	-0.8
Prazosin	38.2	-2	-1	-1.5	-0.2	-0.8	-0.7

Change from baseline in possible range for SF-12 PCS is 6-72. Higher SF-12 score indicates better level of health. (NCT00532493)
Timeframe: This secondary outcome measure was administered at baseline, 6, 10, 14, 18, 22 and 26 weeks (or early termination).

Total CAPS Score

Intervention	scores on a scale (Mean)
	Baseline	Change at Week 6	Change at Week 10	Change at Week 14	Change at Week 18	Change at Week 22	Change at Week 26
Placebo	34.2	0.8	0.3	0.3	-0.4	-0.8	-0.2
Prazosin	35.4	1.8	0.3	1.4	0.5	1.1	0.7

Change from baseline in possible range for CAPS total score is 0-136. Higher score indicates more severe PTSD symptoms. (NCT00532493)
Timeframe: The total CAPS was administered at baseline, 6, 10, 18, and 26 weeks (or early termination).

Intervention	scores on a scale (Mean)
	Baseline	Change at Week 6	Change at Week 10	Change at Week 18	Change at Week 26
Placebo	81.9	-9.1	-12.1	-17.2	-16.2
Prazosin	80.7	-9.9	-11.4	-11.6	-14.1

Article	Year
Trial of Prazosin for Post-Traumatic Stress Disorder in Military Veterans. The New England journal of medicine, 2018, 02-08, Volume: 378, Issue:6 Topics: Adrenergic alpha-1 Receptor Antagonists; Adult; Combined Modality Therapy; Dose-Response Relationshi	2018
Trial of Prazosin for Post-Traumatic Stress Disorder in Military Veterans. The New England journal of medicine, 2018, 02-08, Volume: 378, Issue:6 Topics: Adrenergic alpha-1 Receptor Antagonists; Adult; Combined Modality Therapy; Dose-Response Relationshi	2018
Trial of Prazosin for Post-Traumatic Stress Disorder in Military Veterans. The New England journal of medicine, 2018, 02-08, Volume: 378, Issue:6 Topics: Adrenergic alpha-1 Receptor Antagonists; Adult; Combined Modality Therapy; Dose-Response Relationshi	2018
Trial of Prazosin for Post-Traumatic Stress Disorder in Military Veterans. The New England journal of medicine, 2018, 02-08, Volume: 378, Issue:6 Topics: Adrenergic alpha-1 Receptor Antagonists; Adult; Combined Modality Therapy; Dose-Response Relationshi	2018
Suicidal ideation in military veterans with alcohol dependence and PTSD: The role of hostility. The American journal on addictions, 2018, Volume: 27, Issue:2 Topics: Adrenergic alpha-1 Receptor Antagonists; Adult; Alcoholism; Comorbidity; Double-Blind Method; Female	2018
A Pilot, Randomized Clinical Trial of Bedtime Doses of Prazosin Versus Placebo in Suicidal Posttraumatic Stress Disorder Patients With Nightmares. Journal of clinical psychopharmacology, 2018, Volume: 38, Issue:6 Topics: Adrenergic alpha-1 Receptor Antagonists; Adult; Double-Blind Method; Dreams; Female; Humans; Male; M	2018