Trial Outcomes & Findings for Prazosin for Treating Noncombat Trauma Post-Traumatic Stress Disorder (NCT NCT00183430)

Last Updated: 2018-06-14

Results Overview

The Clinical Global Impression of Change is a 7-point scale that rates global change compared to baseline (1=markedly improved, 2=moderately improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=moderately worse, 7=markedly worse). The Clinical Global Impression of Change is used to determine the impact of treatment effects on meaningful and distinct change in overall sense of well-being and functioning. This outcome measure evaluates change from Baseline to Week 8.

Recruitment status

TERMINATED

Study phase

Target enrollment

20 participants

Primary outcome timeframe

Baseline to Week 8

Results posted on

2018-06-14

Participant Flow

Recruitment was conducted from April 2002 through July 2008. Participants were recruited from VA outpatient clinics and flyers in the community.

no significant events.

Participant milestones

Participant milestones
Measure	Prazosin Participants will receive treatment with prazosin plus psychotherapy Prazosin : Prazosin capsules 1 to 25 mg are taken orally twice per day in divided doses at 10 am and bedtime. Psychotherapy : All participants will undergo psychotherapy during medication treatment period.	Placebo Participants will receive treatment with placebo plus psychotherapy Placebo : Placebo capsules are taken orally twice per day at 10 am and bedtime. Psychotherapy : All participants will undergo psychotherapy during medication treatment period.
Overall Study STARTED	9	11
Overall Study COMPLETED	3	11
Overall Study NOT COMPLETED	6	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Prazosin Participants will receive treatment with prazosin plus psychotherapy Prazosin : Prazosin capsules 1 to 25 mg are taken orally twice per day in divided doses at 10 am and bedtime. Psychotherapy : All participants will undergo psychotherapy during medication treatment period.	Placebo Participants will receive treatment with placebo plus psychotherapy Placebo : Placebo capsules are taken orally twice per day at 10 am and bedtime. Psychotherapy : All participants will undergo psychotherapy during medication treatment period.
Overall Study Adverse Event	1	0
Overall Study Lost to Follow-up	3	0
Overall Study did not meet inclusion criteria	1	0
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Prazosin for Treating Noncombat Trauma Post-Traumatic Stress Disorder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Prazosin n=9 Participants Participants will receive treatment with prazosin plus psychotherapy Prazosin : Prazosin capsules 1 to 25 mg are taken orally twice per day in divided doses at 10 am and bedtime. Psychotherapy : All participants will undergo psychotherapy during medication treatment period.	Placebo n=11 Participants Participants will receive treatment with placebo plus psychotherapy Placebo : Placebo capsules are taken orally twice per day at 10 am and bedtime. Psychotherapy : All participants will undergo psychotherapy during medication treatment period.	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	9 Participants n=5 Participants	11 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	42 years STANDARD_DEVIATION 11.6 • n=5 Participants	46 years STANDARD_DEVIATION 9.4 • n=7 Participants	44 years STANDARD_DEVIATION 10.4 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Region of Enrollment United States	9 participants n=5 Participants	11 participants n=7 Participants	20 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to Week 8

Population: Number of participants analyzed equals the number of participants who were able to complete this assessment at Week 8.

Outcome measures

Outcome measures
Measure	Prazosin n=3 Participants Participants will receive treatment with prazosin plus psychotherapy Prazosin : Prazosin capsules 1 to 25 mg are taken orally twice per day in divided doses at 10 am and bedtime. Psychotherapy : All participants will undergo psychotherapy during medication treatment period.	Placebo n=11 Participants Participants will receive treatment with placebo plus psychotherapy Placebo : Placebo capsules are taken orally twice per day at 10 am and bedtime. Psychotherapy : All participants will undergo psychotherapy during medication treatment period.
Clinical Global Impression of Change	2.33 Units on a Scale Standard Deviation 0.58	3.27 Units on a Scale Standard Deviation 0.90

PRIMARY outcome

Timeframe: Baseline to Week 8

Population: Number of participants analyzed equals the number of participants who were able to complete this assessment at Week 4.

Item B-2 "recurrent distressing dreams of the event" is a single item from teh Clinician Administered PTSD Scale (CAPS). The rating consists of two parts: Frequency plus Intensity. Symptom frequency rated 0 to 4. Symptom intensity rated 0 to 4. Frequency plus Intensity ratings equal the total score. The total minimum score = zero. The total maximum score = 8. A higher score is worse; a lower score is better. This outcome measure evaluates the change in score from Baseline to Week 8.

Outcome measures

Outcome measures
Measure	Prazosin n=3 Participants Participants will receive treatment with prazosin plus psychotherapy Prazosin : Prazosin capsules 1 to 25 mg are taken orally twice per day in divided doses at 10 am and bedtime. Psychotherapy : All participants will undergo psychotherapy during medication treatment period.	Placebo n=11 Participants Participants will receive treatment with placebo plus psychotherapy Placebo : Placebo capsules are taken orally twice per day at 10 am and bedtime. Psychotherapy : All participants will undergo psychotherapy during medication treatment period.
Change in Recurring Distressing Dreams and Difficulty Falling and Staying Asleep Items of the CAPS	-2.00 Units on a Scale Standard Deviation .82	-1.09 Units on a Scale Standard Deviation 1.93

PRIMARY outcome

Timeframe: Baseline to Week 8

Population: Number of participants analyzed equals the number of participants who were able to complete this assessment at Week 8.

Pittsburgh Sleep Quality Index is a self-report questionnaire assessing sleep quality and disturbances over a 1-month time interval. A global score is obtained by summing the seven component subscales (total score range: 0-21). A score of 5 or less indicates good sleep quality. A score of more than 5 indicates poor sleep quality. Change is measured from Baseline to Week 8.

Outcome measures

Outcome measures
Measure	Prazosin n=3 Participants Participants will receive treatment with prazosin plus psychotherapy Prazosin : Prazosin capsules 1 to 25 mg are taken orally twice per day in divided doses at 10 am and bedtime. Psychotherapy : All participants will undergo psychotherapy during medication treatment period.	Placebo n=11 Participants Participants will receive treatment with placebo plus psychotherapy Placebo : Placebo capsules are taken orally twice per day at 10 am and bedtime. Psychotherapy : All participants will undergo psychotherapy during medication treatment period.
Change in Sleep Assessed by the Pittsburgh Sleep Quality Index	4 Units on a Scale Standard Deviation 0.82	2.09 Units on a Scale Standard Deviation 4.42

Adverse Events

Prazosin

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Murray A. Raskind, MD

VA Puget Sound HCS

Phone: 206-277-3797

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Prazosin n=3 participants at risk Participants will receive treatment with prazosin plus psychotherapy Prazosin : Prazosin capsules 1 to 25 mg are taken orally twice per day in divided doses at 10 am and bedtime. Psychotherapy : All participants will undergo psychotherapy during medication treatment period.	Placebo n=11 participants at risk Participants will receive treatment with placebo plus psychotherapy Placebo : Placebo capsules are taken orally twice per day at 10 am and bedtime. Psychotherapy : All participants will undergo psychotherapy during medication treatment period.
Respiratory, thoracic and mediastinal disorders asthma	33.3% 1/3 • Number of events 1 • Adverse events were collected beginning at Baseline (initiation of study drug) through Week 8.	18.2% 2/11 • Number of events 2 • Adverse events were collected beginning at Baseline (initiation of study drug) through Week 8.
Vascular disorders migraine headache	33.3% 1/3 • Number of events 2 • Adverse events were collected beginning at Baseline (initiation of study drug) through Week 8.	0.00% 0/11 • Adverse events were collected beginning at Baseline (initiation of study drug) through Week 8.
General disorders presyncope episodes	33.3% 1/3 • Number of events 2 • Adverse events were collected beginning at Baseline (initiation of study drug) through Week 8.	0.00% 0/11 • Adverse events were collected beginning at Baseline (initiation of study drug) through Week 8.
General disorders sinusitis	33.3% 1/3 • Number of events 1 • Adverse events were collected beginning at Baseline (initiation of study drug) through Week 8.	0.00% 0/11 • Adverse events were collected beginning at Baseline (initiation of study drug) through Week 8.
General disorders adverse drug reaction (not study drug)	33.3% 1/3 • Number of events 2 • Adverse events were collected beginning at Baseline (initiation of study drug) through Week 8.	0.00% 0/11 • Adverse events were collected beginning at Baseline (initiation of study drug) through Week 8.
Skin and subcutaneous tissue disorders Spider Bite	33.3% 1/3 • Number of events 1 • Adverse events were collected beginning at Baseline (initiation of study drug) through Week 8.	0.00% 0/11 • Adverse events were collected beginning at Baseline (initiation of study drug) through Week 8.
Infections and infestations strep throat	33.3% 1/3 • Number of events 1 • Adverse events were collected beginning at Baseline (initiation of study drug) through Week 8.	0.00% 0/11 • Adverse events were collected beginning at Baseline (initiation of study drug) through Week 8.
Infections and infestations Upper respiratory tract infection	100.0% 1/1 • Number of events 1 • Adverse events were collected beginning at Baseline (initiation of study drug) through Week 8.	36.4% 4/11 • Number of events 5 • Adverse events were collected beginning at Baseline (initiation of study drug) through Week 8.
Blood and lymphatic system disorders anemia	0.00% 0/3 • Adverse events were collected beginning at Baseline (initiation of study drug) through Week 8.	9.1% 1/11 • Number of events 1 • Adverse events were collected beginning at Baseline (initiation of study drug) through Week 8.
Renal and urinary disorders bladder prolapse	0.00% 0/3 • Adverse events were collected beginning at Baseline (initiation of study drug) through Week 8.	9.1% 1/11 • Number of events 1 • Adverse events were collected beginning at Baseline (initiation of study drug) through Week 8.
Psychiatric disorders elevated energy and mood	0.00% 0/3 • Adverse events were collected beginning at Baseline (initiation of study drug) through Week 8.	9.1% 1/11 • Number of events 1 • Adverse events were collected beginning at Baseline (initiation of study drug) through Week 8.
Gastrointestinal disorders chest pain consistent with dyspepsia	0.00% 0/3 • Adverse events were collected beginning at Baseline (initiation of study drug) through Week 8.	9.1% 1/11 • Number of events 1 • Adverse events were collected beginning at Baseline (initiation of study drug) through Week 8.
Cardiac disorders Congestive Heart Failure	0.00% 0/3 • Adverse events were collected beginning at Baseline (initiation of study drug) through Week 8.	9.1% 1/11 • Number of events 1 • Adverse events were collected beginning at Baseline (initiation of study drug) through Week 8.
Eye disorders conjunctivitis	0.00% 0/3 • Adverse events were collected beginning at Baseline (initiation of study drug) through Week 8.	9.1% 1/11 • Number of events 2 • Adverse events were collected beginning at Baseline (initiation of study drug) through Week 8.
Cardiac disorders Coronary Artery Disease	0.00% 0/3 • Adverse events were collected beginning at Baseline (initiation of study drug) through Week 8.	9.1% 1/11 • Number of events 1 • Adverse events were collected beginning at Baseline (initiation of study drug) through Week 8.
Renal and urinary disorders Decreased ability to urinate	0.00% 0/3 • Adverse events were collected beginning at Baseline (initiation of study drug) through Week 8.	9.1% 1/11 • Number of events 1 • Adverse events were collected beginning at Baseline (initiation of study drug) through Week 8.
Ear and labyrinth disorders dizziness	0.00% 0/3 • Adverse events were collected beginning at Baseline (initiation of study drug) through Week 8.	9.1% 1/11 • Number of events 1 • Adverse events were collected beginning at Baseline (initiation of study drug) through Week 8.
Reproductive system and breast disorders fibroclastic breast disease	0.00% 0/3 • Adverse events were collected beginning at Baseline (initiation of study drug) through Week 8.	9.1% 1/11 • Number of events 1 • Adverse events were collected beginning at Baseline (initiation of study drug) through Week 8.
General disorders headache	0.00% 0/3 • Adverse events were collected beginning at Baseline (initiation of study drug) through Week 8.	9.1% 1/11 • Number of events 1 • Adverse events were collected beginning at Baseline (initiation of study drug) through Week 8.
Renal and urinary disorders hematuria	0.00% 0/3 • Adverse events were collected beginning at Baseline (initiation of study drug) through Week 8.	9.1% 1/11 • Number of events 1 • Adverse events were collected beginning at Baseline (initiation of study drug) through Week 8.
Infections and infestations herpes simplex 1 outbreak	0.00% 0/3 • Adverse events were collected beginning at Baseline (initiation of study drug) through Week 8.	9.1% 1/11 • Number of events 1 • Adverse events were collected beginning at Baseline (initiation of study drug) through Week 8.
Psychiatric disorders increased sadness	0.00% 0/3 • Adverse events were collected beginning at Baseline (initiation of study drug) through Week 8.	9.1% 1/11 • Number of events 1 • Adverse events were collected beginning at Baseline (initiation of study drug) through Week 8.
Musculoskeletal and connective tissue disorders metacarpophalangeal inflammation	0.00% 0/3 • Adverse events were collected beginning at Baseline (initiation of study drug) through Week 8.	9.1% 1/11 • Number of events 1 • Adverse events were collected beginning at Baseline (initiation of study drug) through Week 8.
General disorders edema	0.00% 0/3 • Adverse events were collected beginning at Baseline (initiation of study drug) through Week 8.	9.1% 1/11 • Number of events 1 • Adverse events were collected beginning at Baseline (initiation of study drug) through Week 8.
Reproductive system and breast disorders menstrual cramps	0.00% 0/3 • Adverse events were collected beginning at Baseline (initiation of study drug) through Week 8.	9.1% 1/11 • Number of events 1 • Adverse events were collected beginning at Baseline (initiation of study drug) through Week 8.
Psychiatric disorders panic attack	0.00% 0/3 • Adverse events were collected beginning at Baseline (initiation of study drug) through Week 8.	9.1% 1/11 • Number of events 1 • Adverse events were collected beginning at Baseline (initiation of study drug) through Week 8.
Cardiac disorders paroxysmal nocturnal dyspnea	0.00% 0/3 • Adverse events were collected beginning at Baseline (initiation of study drug) through Week 8.	9.1% 1/11 • Number of events 1 • Adverse events were collected beginning at Baseline (initiation of study drug) through Week 8.
Infections and infestations pneumonia	0.00% 0/3 • Adverse events were collected beginning at Baseline (initiation of study drug) through Week 8.	9.1% 1/11 • Number of events 1 • Adverse events were collected beginning at Baseline (initiation of study drug) through Week 8.
Renal and urinary disorders protinuria	0.00% 0/3 • Adverse events were collected beginning at Baseline (initiation of study drug) through Week 8.	9.1% 1/11 • Number of events 1 • Adverse events were collected beginning at Baseline (initiation of study drug) through Week 8.
General disorders calf muscle soreness	0.00% 0/3 • Adverse events were collected beginning at Baseline (initiation of study drug) through Week 8.	9.1% 1/11 • Number of events 1 • Adverse events were collected beginning at Baseline (initiation of study drug) through Week 8.
Nervous system disorders sciatic nerve pain	0.00% 0/3 • Adverse events were collected beginning at Baseline (initiation of study drug) through Week 8.	9.1% 1/11 • Number of events 1 • Adverse events were collected beginning at Baseline (initiation of study drug) through Week 8.
General disorders sinus congestion	0.00% 0/3 • Adverse events were collected beginning at Baseline (initiation of study drug) through Week 8.	9.1% 1/11 • Number of events 1 • Adverse events were collected beginning at Baseline (initiation of study drug) through Week 8.
Infections and infestations sinus infection	0.00% 0/3 • Adverse events were collected beginning at Baseline (initiation of study drug) through Week 8.	9.1% 1/11 • Number of events 1 • Adverse events were collected beginning at Baseline (initiation of study drug) through Week 8.
Nervous system disorders ulnar nerve transposition	0.00% 0/3 • Adverse events were collected beginning at Baseline (initiation of study drug) through Week 8.	9.1% 1/11 • Number of events 1 • Adverse events were collected beginning at Baseline (initiation of study drug) through Week 8.