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PTSD Symptom Reduction by Propranolol Given After Trauma Memory Activation

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ClinicalTrials.gov Identifier: NCT00645450
Recruitment Status : Terminated (Difficulty recruiting subjects and loss of study physician for new job)
First Posted : March 27, 2008
Results First Posted : July 2, 2019
Last Update Posted : July 2, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Posttraumatic Stress Disorders
Interventions Drug: Propranolol
Drug: Placebo
Enrollment 9
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Propranolol Placebo
Hide Arm/Group Description Weekly doses of short and long acting propranolol following recollection of traumatic memory Weekly doses of placebo following recollection of traumatic memory
Period Title: Overall Study
Started 5 4
Completed 5 4
Not Completed 0 0
Arm/Group Title Propranolol Placebo Total
Hide Arm/Group Description Weekly doses of short and long acting propranolol following recollection of traumatic memory Weekly doses of placebo following recollection of traumatic memory Total of all reporting groups
Overall Number of Baseline Participants 5 4 9
Hide Baseline Analysis Population Description
Participants included combat Veterans of Afghanistan and Iraqi wars.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 4 participants 9 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
5
 100.0%
4
 100.0%
9
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5 participants 4 participants 9 participants
28  (4.62) 25.5  (.71) 27  (3.39)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 4 participants 9 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
5
 100.0%
4
 100.0%
9
 100.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 5 participants 4 participants 9 participants
5
 100.0%
4
 100.0%
9
 100.0%
1.Primary Outcome
Title PTSD Symptom Severity as Measured by Clinician-Administered PTSD Scale (CAPS)
Hide Description CAPS scale measures intensity and frequency of each symptom separately on a 5 point Likert scale ranging from zero to four. The total CAPS symptom severity score ranges from 0-136, with higher scores indicating greater PTSD symptoms severity
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Data does not include subjects who consented but withdrew prior to receiving study intervention.
Arm/Group Title Propranolol Placebo
Hide Arm/Group Description:
Weekly doses of short and long acting propranolol following recollection of traumatic memory
Weekly doses of placebo following recollection of traumatic memory
Overall Number of Participants Analyzed 3 2
Mean (Standard Deviation)
Unit of Measure: score on a scale
2.60  (1.27) 2.19  (3.10)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Propranolol Placebo
Hide Arm/Group Description Weekly doses of short and long acting propranolol following recollection of traumatic memory Weekly doses of placebo following recollection of traumatic memory
All-Cause Mortality
Propranolol Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/5 (0.00%)      0/4 (0.00%)    
Hide Serious Adverse Events
Propranolol Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/5 (20.00%)      0/4 (0.00%)    
Cardiac disorders     
Incorrect dosage [1]  1/5 (20.00%)  1 0/4 (0.00%)  0
[1]
Incorrect dosage of Propranolol no adverse medical effects.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Propranolol Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/5 (0.00%)      0/4 (0.00%)    
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Scott P. Orr
Organization: Manchester VA Medical Center
Phone: 603-624-4366 ext 6565
EMail: scott.orr@va.gov
Layout table for additonal information
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00645450    
Other Study ID Numbers: MHBA-013-07S
First Submitted: March 19, 2008
First Posted: March 27, 2008
Results First Submitted: February 10, 2014
Results First Posted: July 2, 2019
Last Update Posted: July 2, 2019