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Trial record 2 of 3 for:    17069768 [PUBMED-IDS]

Prazosin for Treating Noncombat Trauma Post-Traumatic Stress Disorder

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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment was conducted from April 2002 through July 2008. Participants were recruited from VA outpatient clinics and flyers in the community.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
no significant events.

Reporting Groups
  Description
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.


Participant Flow:   Overall Study
    Prazosin   Placebo
STARTED   9   11 
COMPLETED   3   11 
NOT COMPLETED   6   0 
Adverse Event                1                0 
Lost to Follow-up                3                0 
did not meet inclusion criteria                1                0 
Withdrawal by Subject                1                0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

Total Total of all reporting groups

Baseline Measures
   Prazosin   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 9   11   20 
Age 
[Units: Participants]
Count of 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 
[Units: Years]
Mean (Standard Deviation)
 42  (11.6)   46  (9.4)   44  (10.4) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      5  55.6%      6  54.5%      11  55.0% 
Male      4  44.4%      5  45.5%      9  45.0% 
Region of Enrollment 
[Units: Participants]
     
United States   9   11   20 


  Outcome Measures

1.  Primary:   Clinical Global Impression of Change   [ Time Frame: Baseline to Week 8 ]

2.  Primary:   Change in Recurring Distressing Dreams and Difficulty Falling and Staying Asleep Items of the CAPS   [ Time Frame: Baseline to Week 8 ]

3.  Primary:   Change in Sleep Assessed by the Pittsburgh Sleep Quality Index   [ Time Frame: Baseline to Week 8 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: Murray.Raskind@va.gov


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