Trial Outcomes & Findings for PTSD Symptom Reduction by Propranolol Given After Trauma Memory Activation (NCT NCT00645450)

Last Updated: 2019-07-02

Results Overview

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

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

9 participants

Primary outcome timeframe

3 years

Results posted on

2019-07-02

Participant Flow

Participant milestones

Participant milestones
Measure	Propranolol Weekly doses of short and long acting propranolol following recollection of traumatic memory	Placebo Weekly doses of placebo following recollection of traumatic memory
Overall Study STARTED	5	4
Overall Study COMPLETED	5	4
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

PTSD Symptom Reduction by Propranolol Given After Trauma Memory Activation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Propranolol n=5 Participants Weekly doses of short and long acting propranolol following recollection of traumatic memory	Placebo n=4 Participants Weekly doses of placebo following recollection of traumatic memory	Total n=9 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=99 Participants	4 Participants n=107 Participants	9 Participants n=206 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Continuous	28 years STANDARD_DEVIATION 4.62 • n=99 Participants	25.5 years STANDARD_DEVIATION .71 • n=107 Participants	27 years STANDARD_DEVIATION 3.39 • n=206 Participants
Sex: Female, Male Female	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Sex: Female, Male Male	5 Participants n=99 Participants	4 Participants n=107 Participants	9 Participants n=206 Participants
Region of Enrollment United States	5 Participants n=99 Participants	4 Participants n=107 Participants	9 Participants n=206 Participants

PRIMARY outcome

Timeframe: 3 years

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

Outcome measures

Outcome measures
Measure	Propranolol n=3 Participants Weekly doses of short and long acting propranolol following recollection of traumatic memory	Placebo n=2 Participants Weekly doses of placebo following recollection of traumatic memory
PTSD Symptom Severity as Measured by Clinician-Administered PTSD Scale (CAPS)	2.60 score on a scale Standard Deviation 1.27	2.19 score on a scale Standard Deviation 3.10

Adverse Events

Propranolol

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Propranolol n=5 participants at risk Weekly doses of short and long acting propranolol following recollection of traumatic memory	Placebo n=4 participants at risk Weekly doses of placebo following recollection of traumatic memory
Cardiac disorders Incorrect dosage	20.0% 1/5 • Number of events 1	0.00% 0/4

Other adverse events

Adverse event data not reported

Additional Information

Dr. Scott P. Orr

Manchester VA Medical Center

Phone: 603-624-4366

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place