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

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	Propranolol	Placebo
Arm/Group Description	Weekly doses of short and long acti...	Weekly doses of placebo following r...
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

Baseline Characteristics

Arm/Group Title		Propranolol	Placebo	Total
Arm/Group Description		Weekly doses of short and long acti...	Weekly doses of placebo following r...	Total of all reporting groups
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
Baseline Analysis Population Description		...
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
United States		5 100.0%	4 100.0%	9 100.0%

Outcome Measures

1.Primary Outcome


Title	PTSD Symptom Severity as Measured by Clinician-Administered PTSD Scale (CAPS)
Description	CAPS scale measures intensity and frequency of each symptom separately...
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

Outcome Measure Data

Analysis Population Description

Data does not include subjects who consented but withdrew prior to receiving study intervention.


Arm/Group Title	Propranolol	Placebo
Arm/Group Description:	Weekly doses of short and long acti...	Weekly doses of placebo following r...
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)

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	Propranolol		Placebo
Arm/Group Description	Weekly doses of short and long acti...		Weekly doses of placebo following r...
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%)
Serious Adverse Events 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.
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%)

Limitations and Caveats

[Not Specified]

More Information

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

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