Trial Outcomes & Findings for Prazosin vs Paroxetine in Combat Stress-Related Post-Traumatic Stress Disorder (PTSD) Nightmares & Sleep Disturbance (NCT NCT00202449)

NCT ID: NCT00202449

Last Updated: 2018-07-10

Results Overview

Item B-2 "recurrent distressing dreams of the event" is a single item from the Clinician Administered PTSD Scale. The rating consists of two parts: Frequency and Intensity. Symptom frequency rated 0 to 4. Symptom intensity rated 0 to 4. Frequency plus Intensity ratings equal the total score. A higher score is worse; a lower score is better. This outcome measure evaluates the change in score from Baseline to Week 12. Minimum = 0 Maximum = 8

Recruitment status

TERMINATED

Study phase

Target enrollment

59 participants

Primary outcome timeframe

Baseline and Week 12

Results posted on

2018-07-10

Participant Flow

Participant milestones

Participant milestones
Measure	Prazosin Prazosin is a brain active alpha-1 adrenal receptor antagonist. Dose initiated at an initial dose of 1 mg qhs and titrated up to a maximum dose of 30 mg/day according to weight, age and presence or absence of daytime symptoms.	Paroxetine Paroxetine is a Selective Serotonin Reuptake Inhibitor. Dose started and maintained at 20 mg q10A.	Placebo Placebo is an inert substance used as a standard comparator in clinical pharmacologic trials.
Overall Study STARTED	18	20	21
Overall Study COMPLETED	7	9	9
Overall Study NOT COMPLETED	11	11	12

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Prazosin vs Paroxetine in Combat Stress-Related Post-Traumatic Stress Disorder (PTSD) Nightmares & Sleep Disturbance

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Prazosin n=18 Participants Prazosin is a brain active alpha-1 adrenal receptor antagonist. Dose initiated at an initial dose of 1 mg qhs and titrated up to a maximum dose of 30 mg/day according to weight, age and presence or absence of daytime symptoms.	Paroxetine n=20 Participants Paroxetine is a Selective Serotonin Reuptake Inhibitor. Dose started and maintained at 20 mg q10A.	Placebo n=21 Participants Placebo is an inert substance used as a standard comparator in clinical pharmacologic trials.	Total n=59 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	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=5 Participants	20 Participants n=7 Participants	21 Participants n=5 Participants	59 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	29 years STANDARD_DEVIATION 7 • n=5 Participants	28 years STANDARD_DEVIATION 5 • n=7 Participants	32 years STANDARD_DEVIATION 9 • n=5 Participants	30 years STANDARD_DEVIATION 7 • n=4 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	19 Participants n=7 Participants	20 Participants n=5 Participants	56 Participants n=4 Participants
Region of Enrollment United States	18 participants n=5 Participants	20 participants n=7 Participants	21 participants n=5 Participants	59 participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline and Week 12

Population: Number of subjects analyzed equals the number of subjects who were able to complete this assessment at week 12 (e.g., completed the study).

Outcome measures

Outcome measures
Measure	Prazosin n=9 Participants Prazosin is a brain active alpha-1 adrenal receptor antagonist. Dose initiated at an initial dose of 1 mg qhs and titrated up to a maximum dose of 30 mg/day according to weight, age and presence or absence of daytime symptoms.	Paroxetine n=7 Participants Paroxetine is a Selective Serotonin Reuptake Inhibitor. Dose started and maintained at 20 mg q10A.	Placebo n=9 Participants Placebo is an inert substance used as a standard comparator in clinical pharmacologic trials.
Change in Combat Trauma-related Nightmares From the Clinician Administered PTSD Scale (CAPS) Recurrent Distressing Dreams Item at Week 12	-1.29 scale points Standard Deviation 1.11	-3.11 scale points Standard Deviation 2.52	-2.67 scale points Standard Deviation 3.0

PRIMARY outcome

Timeframe: Baseline to Week 12

Population: Number of subjects analyzed equals the number of subjects who were able to complete this assessment at Week 12 (e.g., completed the study).

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 12.

Outcome measures

Outcome measures
Measure	Prazosin n=6 Participants Prazosin is a brain active alpha-1 adrenal receptor antagonist. Dose initiated at an initial dose of 1 mg qhs and titrated up to a maximum dose of 30 mg/day according to weight, age and presence or absence of daytime symptoms.	Paroxetine n=9 Participants Paroxetine is a Selective Serotonin Reuptake Inhibitor. Dose started and maintained at 20 mg q10A.	Placebo n=9 Participants Placebo is an inert substance used as a standard comparator in clinical pharmacologic trials.
Change in Sleep From the Pittsburgh Sleep Quality Index From Baseline to Week 12	-2.33 scale points Standard Deviation 2.94	-6.44 scale points Standard Deviation 3.91	-3.33 scale points Standard Deviation 5.45

PRIMARY outcome

Timeframe: Baseline to Week 12

Population: Number of subjects analyzed equals the number of subjects who were able to complete this assessment at week 12 (e.g., completed the study).

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 CGIC 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 12.

Outcome measures

Outcome measures
Measure	Prazosin n=7 Participants Prazosin is a brain active alpha-1 adrenal receptor antagonist. Dose initiated at an initial dose of 1 mg qhs and titrated up to a maximum dose of 30 mg/day according to weight, age and presence or absence of daytime symptoms.	Paroxetine n=9 Participants Paroxetine is a Selective Serotonin Reuptake Inhibitor. Dose started and maintained at 20 mg q10A.	Placebo n=9 Participants Placebo is an inert substance used as a standard comparator in clinical pharmacologic trials.
Change in Global Trauma-related Symptom Severity and Functioning From the Clinical Global Impression of Change From Baseline to Week 12	3.14 scale points Standard Deviation 1.86	2.11 scale points Standard Deviation 1.05	2.33 scale points Standard Deviation 1.22

Adverse Events

Prazosin

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Paroxetine

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Murray Raskind, MD

VA PSHCS

Phone: 206-764-2702

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Prazosin n=18 participants at risk Prazosin is a brain active alpha-1 adrenal receptor antagonist. Dose initiated at an initial dose of 1 mg qhs and titrated up to a maximum dose of 30 mg/day according to weight, age and presence or absence of daytime symptoms.	Paroxetine n=20 participants at risk Paroxetine is a Selective Serotonin Reuptake Inhibitor. Dose started and maintained at 20 mg q10A.	Placebo n=21 participants at risk Placebo is an inert substance used as a standard comparator in clinical pharmacologic trials.
Respiratory, thoracic and mediastinal disorders nasal congestion	0.00% 0/18 • 12 weeks Adverse events were collected over the course of 12 weeks.	0.00% 0/20 • 12 weeks Adverse events were collected over the course of 12 weeks.	4.8% 1/21 • Number of events 1 • 12 weeks Adverse events were collected over the course of 12 weeks.
General disorders dry mouth	0.00% 0/18 • 12 weeks Adverse events were collected over the course of 12 weeks.	0.00% 0/20 • 12 weeks Adverse events were collected over the course of 12 weeks.	4.8% 1/21 • Number of events 1 • 12 weeks Adverse events were collected over the course of 12 weeks.
Ear and labyrinth disorders dizziness	0.00% 0/18 • 12 weeks Adverse events were collected over the course of 12 weeks.	0.00% 0/20 • 12 weeks Adverse events were collected over the course of 12 weeks.	4.8% 1/21 • Number of events 1 • 12 weeks Adverse events were collected over the course of 12 weeks.
Gastrointestinal disorders stomach pain	0.00% 0/18 • 12 weeks Adverse events were collected over the course of 12 weeks.	0.00% 0/20 • 12 weeks Adverse events were collected over the course of 12 weeks.	4.8% 1/21 • Number of events 3 • 12 weeks Adverse events were collected over the course of 12 weeks.
Nervous system disorders numbness in face and hands	0.00% 0/18 • 12 weeks Adverse events were collected over the course of 12 weeks.	0.00% 0/20 • 12 weeks Adverse events were collected over the course of 12 weeks.	4.8% 1/21 • Number of events 1 • 12 weeks Adverse events were collected over the course of 12 weeks.
Cardiac disorders heart palpitations	0.00% 0/18 • 12 weeks Adverse events were collected over the course of 12 weeks.	0.00% 0/20 • 12 weeks Adverse events were collected over the course of 12 weeks.	4.8% 1/21 • Number of events 1 • 12 weeks Adverse events were collected over the course of 12 weeks.
Psychiatric disorders anxiety with palpitations	0.00% 0/18 • 12 weeks Adverse events were collected over the course of 12 weeks.	0.00% 0/20 • 12 weeks Adverse events were collected over the course of 12 weeks.	4.8% 1/21 • Number of events 1 • 12 weeks Adverse events were collected over the course of 12 weeks.
Skin and subcutaneous tissue disorders allertic reaction to tramadol - hives/itching	0.00% 0/18 • 12 weeks Adverse events were collected over the course of 12 weeks.	0.00% 0/20 • 12 weeks Adverse events were collected over the course of 12 weeks.	4.8% 1/21 • Number of events 1 • 12 weeks Adverse events were collected over the course of 12 weeks.
Eye disorders PAK bilateral eye surgery	0.00% 0/18 • 12 weeks Adverse events were collected over the course of 12 weeks.	5.0% 1/20 • Number of events 1 • 12 weeks Adverse events were collected over the course of 12 weeks.	0.00% 0/21 • 12 weeks Adverse events were collected over the course of 12 weeks.
Eye disorders conjunctivitis	5.6% 1/18 • Number of events 1 • 12 weeks Adverse events were collected over the course of 12 weeks.	0.00% 0/20 • 12 weeks Adverse events were collected over the course of 12 weeks.	0.00% 0/21 • 12 weeks Adverse events were collected over the course of 12 weeks.
Renal and urinary disorders nocturnal urinary incontinence	5.6% 1/18 • Number of events 1 • 12 weeks Adverse events were collected over the course of 12 weeks.	0.00% 0/20 • 12 weeks Adverse events were collected over the course of 12 weeks.	0.00% 0/21 • 12 weeks Adverse events were collected over the course of 12 weeks.
Gastrointestinal disorders diarrhea	11.1% 2/18 • Number of events 4 • 12 weeks Adverse events were collected over the course of 12 weeks.	0.00% 0/20 • 12 weeks Adverse events were collected over the course of 12 weeks.	0.00% 0/21 • 12 weeks Adverse events were collected over the course of 12 weeks.
Psychiatric disorders panic attack	5.6% 1/18 • Number of events 2 • 12 weeks Adverse events were collected over the course of 12 weeks.	0.00% 0/20 • 12 weeks Adverse events were collected over the course of 12 weeks.	0.00% 0/21 • 12 weeks Adverse events were collected over the course of 12 weeks.
Eye disorders change in vision	5.6% 1/18 • Number of events 1 • 12 weeks Adverse events were collected over the course of 12 weeks.	0.00% 0/20 • 12 weeks Adverse events were collected over the course of 12 weeks.	0.00% 0/21 • 12 weeks Adverse events were collected over the course of 12 weeks.
General disorders central chest discomfort	5.6% 1/18 • Number of events 1 • 12 weeks Adverse events were collected over the course of 12 weeks.	0.00% 0/20 • 12 weeks Adverse events were collected over the course of 12 weeks.	0.00% 0/21 • 12 weeks Adverse events were collected over the course of 12 weeks.
Renal and urinary disorders reaction to study drug (paroxetine)	0.00% 0/18 • 12 weeks Adverse events were collected over the course of 12 weeks.	5.0% 1/20 • Number of events 1 • 12 weeks Adverse events were collected over the course of 12 weeks.	0.00% 0/21 • 12 weeks Adverse events were collected over the course of 12 weeks.
Renal and urinary disorders abnormal ejaculation	0.00% 0/18 • 12 weeks Adverse events were collected over the course of 12 weeks.	5.0% 1/20 • Number of events 1 • 12 weeks Adverse events were collected over the course of 12 weeks.	0.00% 0/21 • 12 weeks Adverse events were collected over the course of 12 weeks.
Psychiatric disorders difficulty concentrating	0.00% 0/18 • 12 weeks Adverse events were collected over the course of 12 weeks.	0.00% 0/20 • 12 weeks Adverse events were collected over the course of 12 weeks.	4.8% 1/21 • Number of events 1 • 12 weeks Adverse events were collected over the course of 12 weeks.
Gastrointestinal disorders surgery for dyskinesia of esophagus and diverticulum of esophagus, acquired.	5.6% 1/18 • Number of events 1 • 12 weeks Adverse events were collected over the course of 12 weeks.	0.00% 0/20 • 12 weeks Adverse events were collected over the course of 12 weeks.	0.00% 0/21 • 12 weeks Adverse events were collected over the course of 12 weeks.
Gastrointestinal disorders vomiting	5.6% 1/18 • Number of events 1 • 12 weeks Adverse events were collected over the course of 12 weeks.	0.00% 0/20 • 12 weeks Adverse events were collected over the course of 12 weeks.	0.00% 0/21 • 12 weeks Adverse events were collected over the course of 12 weeks.
Musculoskeletal and connective tissue disorders shoulder pain	0.00% 0/18 • 12 weeks Adverse events were collected over the course of 12 weeks.	5.0% 1/20 • Number of events 1 • 12 weeks Adverse events were collected over the course of 12 weeks.	0.00% 0/21 • 12 weeks Adverse events were collected over the course of 12 weeks.