ClinicalTrials.gov
ClinicalTrials.gov Menu

Prazosin for Treating Noncombat Trauma Post-Traumatic Stress Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00183430
Recruitment Status : Terminated (Insufficient Enrollment)
First Posted : September 16, 2005
Results First Posted : November 27, 2012
Last Update Posted : June 14, 2018
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Seattle Institute for Biomedical and Clinical Research

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Post-Traumatic Stress Disorder
Sleep Initiation and Maintenance Disorders
Interventions Drug: Prazosin
Drug: Placebo
Behavioral: Psychotherapy
Enrollment 20
Recruitment Details Recruitment was conducted from April 2002 through July 2008. Participants were recruited from VA outpatient clinics and flyers in the community.
Pre-assignment Details no significant events.
Arm/Group Title Prazosin Placebo
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 9 11
Completed 3 11
Not Completed 6 0
Reason Not Completed
Adverse Event             1             0
Lost to Follow-up             3             0
did not meet inclusion criteria             1             0
Withdrawal by Subject             1             0
Arm/Group Title Prazosin Placebo Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 9 11 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 11 participants 20 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
9
 100.0%
11
 100.0%
20
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 9 participants 11 participants 20 participants
42  (11.6) 46  (9.4) 44  (10.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 11 participants 20 participants
Female
5
  55.6%
6
  54.5%
11
  55.0%
Male
4
  44.4%
5
  45.5%
9
  45.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 9 participants 11 participants 20 participants
9 11 20
1.Primary Outcome
Title Clinical Global Impression of Change
Hide Description 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.
Time Frame Baseline to Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Number of participants analyzed equals the number of participants who were able to complete this assessment at Week 8.
Arm/Group Title Prazosin Placebo
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 3 11
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
2.33  (0.58) 3.27  (0.90)
2.Primary Outcome
Title Change in Recurring Distressing Dreams and Difficulty Falling and Staying Asleep Items of the CAPS
Hide Description 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.
Time Frame Baseline to Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Number of participants analyzed equals the number of participants who were able to complete this assessment at Week 4.
Arm/Group Title Prazosin Placebo
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 3 11
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
-2.00  (.82) -1.09  (1.93)
3.Primary Outcome
Title Change in Sleep Assessed by the Pittsburgh Sleep Quality Index
Hide Description 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.
Time Frame Baseline to Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Number of participants analyzed equals the number of participants who were able to complete this assessment at Week 8.
Arm/Group Title Prazosin Placebo
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 3 11
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
4  (0.82) 2.09  (4.42)
Time Frame Adverse events were collected beginning at Baseline (initiation of study drug) through Week 8.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Prazosin Placebo
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Prazosin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Prazosin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/3 (0.00%)      0/11 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Prazosin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/3 (66.67%)      8/11 (72.73%)    
Blood and lymphatic system disorders     
anemia * 1  0/3 (0.00%)  0 1/11 (9.09%)  1
Cardiac disorders     
Congestive Heart Failure * 1  0/3 (0.00%)  0 1/11 (9.09%)  1
Coronary Artery Disease * 1  0/3 (0.00%)  0 1/11 (9.09%)  1
paroxysmal nocturnal dyspnea * 1  0/3 (0.00%)  0 1/11 (9.09%)  1
Ear and labyrinth disorders     
dizziness * 1  0/3 (0.00%)  0 1/11 (9.09%)  1
Eye disorders     
conjunctivitis * 1  0/3 (0.00%)  0 1/11 (9.09%)  2
Gastrointestinal disorders     
chest pain consistent with dyspepsia * 1  0/3 (0.00%)  0 1/11 (9.09%)  1
General disorders     
presyncope episodes * 1  1/3 (33.33%)  2 0/11 (0.00%)  0
sinusitis * 1  1/3 (33.33%)  1 0/11 (0.00%)  0
adverse drug reaction (not study drug) * 1  1/3 (33.33%)  2 0/11 (0.00%)  0
headache * 1  0/3 (0.00%)  0 1/11 (9.09%)  1
edema * 1  0/3 (0.00%)  0 1/11 (9.09%)  1
calf muscle soreness * 1  0/3 (0.00%)  0 1/11 (9.09%)  1
sinus congestion * 1  0/3 (0.00%)  0 1/11 (9.09%)  1
Infections and infestations     
strep throat * 1  1/3 (33.33%)  1 0/11 (0.00%)  0
Upper respiratory tract infection * 1  1/1 (100.00%)  1 4/11 (36.36%)  5
herpes simplex 1 outbreak * 1  0/3 (0.00%)  0 1/11 (9.09%)  1
pneumonia * 1  0/3 (0.00%)  0 1/11 (9.09%)  1
sinus infection * 1  0/3 (0.00%)  0 1/11 (9.09%)  1
Musculoskeletal and connective tissue disorders     
metacarpophalangeal inflammation * 1  0/3 (0.00%)  0 1/11 (9.09%)  1
Nervous system disorders     
sciatic nerve pain * 1  0/3 (0.00%)  0 1/11 (9.09%)  1
ulnar nerve transposition * 1  0/3 (0.00%)  0 1/11 (9.09%)  1
Psychiatric disorders     
elevated energy and mood * 1  0/3 (0.00%)  0 1/11 (9.09%)  1
increased sadness * 1  0/3 (0.00%)  0 1/11 (9.09%)  1
panic attack * 1  0/3 (0.00%)  0 1/11 (9.09%)  1
Renal and urinary disorders     
bladder prolapse * 1  0/3 (0.00%)  0 1/11 (9.09%)  1
Decreased ability to urinate * 1  0/3 (0.00%)  0 1/11 (9.09%)  1
hematuria * 1  0/3 (0.00%)  0 1/11 (9.09%)  1
protinuria * 1  0/3 (0.00%)  0 1/11 (9.09%)  1
Reproductive system and breast disorders     
fibroclastic breast disease * 1  0/3 (0.00%)  0 1/11 (9.09%)  1
menstrual cramps * 1  0/3 (0.00%)  0 1/11 (9.09%)  1
Respiratory, thoracic and mediastinal disorders     
asthma * 1  1/3 (33.33%)  1 2/11 (18.18%)  2
Skin and subcutaneous tissue disorders     
Spider Bite * 1  1/3 (33.33%)  1 0/11 (0.00%)  0
Vascular disorders     
migraine headache * 1  1/3 (33.33%)  2 0/11 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, other
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Murray A. Raskind, MD
Organization: VA Puget Sound HCS
Phone: 206-277-3797
Publications:
Responsible Party: Seattle Institute for Biomedical and Clinical Research
ClinicalTrials.gov Identifier: NCT00183430     History of Changes
Other Study ID Numbers: R01MH069867 ( U.S. NIH Grant/Contract )
R01MH069867 ( U.S. NIH Grant/Contract )
DATR AD-TS
First Submitted: September 13, 2005
First Posted: September 16, 2005
Results First Submitted: October 22, 2012
Results First Posted: November 27, 2012
Last Update Posted: June 14, 2018