Post-traumatic Stress DisorderPhase 4NCT01555554
Perioperative Propranolol in Patients With Post Traumatic Stress Disorder (PTSD)
A Phase 4 study testing Propranolol Hydrochloride in people with Post-traumatic Stress Disorder, run by University of California, San Francisco at 1 site in United States.
Trial summary
Understanding what treatments may facilitate perioperative care of Veterans with posttraumatic stress disorder (PTSD) is of great importance to the U.S. health care system. Patients with PTSD are characterized by elevated central nervous system catecholamine concentrations and exaggerated and prolonged adrenergic… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Post-traumatic Stress Disorder
- What is being tested?
- Propranolol Hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Jun 2019
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects scheduled for any surgical procedure under general anesthesia or combined general-regional anesthesia, with the exception of open-heart or intracranial surgery. Regional anesthesia includes: 1) Epidural anesthesia, 2) Sub-arachnoid block (spinal), or 3)any regional nerve block
- Anticipated postoperative hospital admission (defined as at least one overnight hospital stay)
Who cannot join
- Veterans will be excluded if:
- They are on beta blocker therapy at the time of the preoperative baseline assessment
- They report sensitivity or allergies to propranolol, or a history of PTSD exacerbation with prior propranolol therapy
- Veterans who fulfill the AHA/ACC level I recommendation criteria for perioperative beta blocker therapy (e.g., metoprolol, atenolol) and should not be randomized to placebo group
- Medical exclusions criteria: high grade heart block without pacemaker (all patients with 2nd and 3rd degree heart block), marked resting bradycardia (heart rate ≤ 55 beats per minute), blood pressure < 100 mmHg, uncompensated congested heart failure, severe hyperactive airway disease, and Raynaud's disease
- Pregnancy
Show all 9Show fewer
- Current use of medication that may involve potentially dangerous interaction with propranolol
- Circumstances that, in the opinion of the principal investigator, would preclude participation in a study of this type (e.g. medical concerns or difficulty in long-term followup).
- Open-heart surgery and intracranial surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
San Francisco VA Medical Center
San Francisco, California, 94121
About this study
Official title: Effect of Prophylactic, Perioperative Propranolol on Peri- and Postoperative Complications in Patients With Post Traumatic Stress Disorder
Understanding what treatments may facilitate perioperative care of Veterans with posttraumatic stress disorder (PTSD) is of great importance to the U.S. health care system.
Patients with PTSD are characterized by elevated central nervous system catecholamine concentrations and exaggerated and prolonged adrenergic responses to stress stimuli. At present, there are no data on the effects of perioperative beta blocker therapy in patients with PTSD, despite the rising significance of PTSD in Veteran populations.
Read more
This prospective, double-blind study proposes to randomize 150 Veterans with PTSD scheduled for orthopedic, thoracic or vascular surgery at the San Francisco VA Medical Center to either a 14-day course of propranolol or placebo. This study will then follow these Veterans for a one-year period to evaluate the effects of the intervention on Veterans' surgical outcomes.
The investigators hypothesize that patients with PTSD randomized to the propranolol group will demonstrate a reduced incidence of perioperative and postoperative morbidity and mortality.
- Conditions
- Post-traumatic Stress Disorder
- Being tested
- Propranolol Hydrochloride, Placebo
- Keywords
- Post-traumatic stress disorder, Propranolol, surgery, anesthesia
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propranolol HydrochlorideDrug
Also called Inderal, Inderal LA, Avlocardyl, Avlocardyl Retard
Propranolol will be taken for a total of 14 days. On the morning of the surgery, prior to entry into the operating room, patients will receive the first dose of the study drug (the PDR recommended starting dose of Propranolol XL- Extended Release). Patients will take one 60 mg pill on the morning of surgery.
On post operative day #1, patients will take one pill of receive propranolol XL 80 mg (once daily by mouth).
On post operative days #2-#9, patients will take one pill of propranolol XL 120 mg (once daily by mouth).
On post operative days #10-11, patients will take one pill of propranolol XL 80 mg (once daily by mouth).
On post operative days #12-13, patients will take one pill of propranolol XL 60 mg (once daily by mouth).
This will complete the course of propranolol.
PlaceboOther
The placebo pill will be taken for a total of 14 days. On the morning of the surgery, prior to entry into the operating room, patients will receive the first placebo pill to be taken once daily by mouth.
On post operative days #1-13, patients will take one placebo pill (once daily by mouth).
This will complete the course of the placebo.
| Study group | Role | What they receive |
|---|---|---|
| Propranolol Hydrochloride | Experimental | Not described Receives: Drug: Propranolol Hydrochloride |
| Placebo Group | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICU Length of Stay
Measured using patient medical records
Measured: Truncated at 30 days after admission to ICU
Hospital Length of Stay
Measured using patient medical records
Measured: Truncated at 30 days after admission to ICU
Postoperative Delirium
Measured using Confusion Assessment Method (CAM-CAM-ICU)
Measured: Participants will be followed for the duration of hospital stay, an expected average of 1 week
Postoperative Renal Dysfunction
Measured using Serum Creatinine laboratory values
Measured: Participants will be followed for the duration of hospital stay, an expected average of 1 week
Secondary outcomes (13)
Perioperative Complications
Measured using patient medical records
Measured: Participants will be followed for the duration of hospital stay, an expected average of 1 week
Pain Intensity
Pain intensity was measured using a Numerical Rating Scale (NRS). The range of the NRS is 0 and 10, where zero represents no pain at all and 10 represents the worst pain ever possible.
Measured: 12 months
Pain Unpleasantness
Measured using the Numerical Rating Scale (NRS). The range of the NRS is 0 and 10, where zero represents no pain at all and 10 represents the worst pain ever possible.
Measured: 12 months
Perioperative Opioids Use
Measured using patient medical records.
Measured: Participants will be followed from preoperative baseline to 1 year postoperative
Required Mechanical Ventilation
Measured using patient medical records
Measured: Participants will be followed for the duration of hospital stay, an expected average of 1 week
Change in Posttraumatic Diagnostic Scale (PDS) PTSD Symptoms Severity Score
The Posttraumatic Diagnostic Scale (PDS) Scale includes a PTSD Symptoms Severity Score ranging from 0 to 51, with higher scores indicating more severe depression.
Measured: Baseline and 12 months
Change in Mental Component Summary (MCS) Scores From the Short Form-36 Questionnaire (SF-36)
The Mental Component Summary (MCS) score is derived from the Short Form-36 Questionnaire (SF-36), a validated measure of health-related quality of life. Scores range from 0 to 100, with higher scores indicating better mental health and lower scores indicating worse mental health.
Measured: Participants will be followed from preoperative baseline to 1 year postoperative
Change in Physical Component Summary (PCS) Scores From the Short Form-36 Questionnaire (SF-36)
The Physical Component Summary (PCS) score is derived from the Short Form-36 Questionnaire (SF-36), a validated measure of health-related quality of life. Scores range from 0 to 100, with higher scores indicating better physical health and lower scores indicating worse physical health.
Measured: Participants will be followed from preoperative baseline to 1 year postoperative
Change in Pittsburgh Sleep Quality Index (PSQI) Score
The Pittsburgh Sleep Quality Index (PSQI) is a validated self-reported questionnaire assessing sleep quality. Total scores range from 0 to 21, with higher scores indicating worse sleep quality and lower scores indicating better sleep quality
Measured: Participants will be followed from preoperative baseline to 1 year postoperative
Change in Beck Depression Inventory (BDI) Score
The Beck Depression Inventory (BDI) is a validated self-report measure of depressive symptoms. Total scores range from 0 to 63, with higher scores indicating more severe depressive symptoms (worse outcome) and lower scores indicating fewer or minimal symptoms (better outcome).
Measured: Participants will be followed from preoperative baseline to 1 year postoperative
Postoperative Neurocognitive Dysfunction Score
The Mini-Mental State Examination (MMSE) is a widely used screening tool for cognitive function. Total scores range from 0 to 30, with higher scores indicating better cognitive function and lower scores indicating greater cognitive impairment.
Measured: Participants will be followed from preoperative baseline to 1 year postoperative
30-day, 3-month, and 1-year Mortality
Measured using patient medical records
Measured: Participants will be followed from preoperative baseline to 1 year postoperative
Postoperative Complications
Measured using patient medical records - Composite outcome measure that included, delirium, stroke, myocardial infarction, acute kidney injury, new atrial fibrilation, infection, or congestive heart failure between the surgery and 1-yr.
Measured: Participants will be followed to 1 year postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2012 (estimated)
- Study startMay 2012
- Primary completionJun 2018
- Study completionJun 2019
Why it stopped: Unable to meet enrollment goals
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Post-traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense, Northern California Institute of Research and Education
- Responsible party
- Sponsor
- Investigators
- Marek Brzezinski, M.D., Ph.D., Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01555554
- Sponsor's protocol ID
- W81XWH-10-2-0078
- Status last verified
- Jun 2026
- First submitted
- 5 Mar 2012
- Last updated
- 2 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Prophylactic, Perioperative Propranolol on Peri- and Postoperative Complications in Patients With Post Traumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT01555554
- Acronym / sponsor ID
- W81XWH-10-2-0078
- Conditions
- Post-traumatic Stress Disorder
- Keywords
- Post-traumatic stress disorder, Propranolol, surgery, anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to meet enrollment goals
- Enrolment
- 59 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- United States Department of Defense, Northern California Institute of Research and Education
- Study start
- May 2012
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 15 Mar 2012 (estimated)
- Results
- Posted 2 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Understanding what treatments may facilitate perioperative care of Veterans with posttraumatic stress disorder (PTSD) is of great importance to the U.S. health care system.
Patients with PTSD are characterized by elevated central nervous system catecholamine concentrations and exaggerated and prolonged adrenergic responses to stress stimuli. At present, there are no data on the effects of perioperative beta blocker therapy in patients with PTSD, despite the rising significance of PTSD in Veteran populations.
This prospective, double-blind study proposes to randomize 150 Veterans with PTSD scheduled for orthopedic, thoracic or vascular surgery at the San Francisco VA Medical Center to either a 14-day course of propranolol or placebo. This study will then follow these Veterans for a one-year period to evaluate the effects of the intervention on Veterans' surgical outcomes.
The investigators hypothesize that patients with PTSD randomized to the propranolol group will demonstrate a reduced incidence of perioperative and postoperative morbidity and mortality.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propranolol Hydrochloride | Experimental | Drug: Propranolol Hydrochloride |
| Placebo Group | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects scheduled for any surgical procedure under general anesthesia or combined general-regional anesthesia, with the exception of open-heart or intracranial surgery. Regional anesthesia includes: 1) Epidural anesthesia, 2) Sub-arachnoid block (spinal), or 3)any regional nerve block
- Anticipated postoperative hospital admission (defined as at least one overnight hospital stay)
Key exclusion criteria (9 listed)
- They are on beta blocker therapy at the time of the preoperative baseline assessment
- They report sensitivity or allergies to propranolol, or a history of PTSD exacerbation with prior propranolol therapy
- Veterans who fulfill the AHA/ACC level I recommendation criteria for perioperative beta blocker therapy (e.g., metoprolol, atenolol) and should not be randomized to placebo group
- Medical exclusions criteria: high grade heart block without pacemaker (all patients with 2nd and 3rd degree heart block), marked resting bradycardia (heart rate ≤ 55 beats per minute), blood pressure < 100 mmHg, uncompensated congested heart failure, severe hyperactive airway disease, and Raynaud's disease
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Propranolol HydrochlorideAlso: Inderal, Inderal LA, Avlocardyl, Avlocardyl RetardPropranolol will be taken for a total of 14 days. On the morning of the surgery, prior to entry into the operating room, patients will receive the first dose of the study drug (the PDR recommended starting dose of Propranolol XL- Extended Release). Patients will take one 60 mg pill on the morning of surgery. On post operative day #1, patients will take one pill of receive propranolol XL 80 mg (once daily by mouth). On post operative days #2-#9, patients will take one pill of propranolol XL 120 mg (once daily by mouth). On post operative days #10-11, patients will take one pill of propranolol XL 80 mg (once daily by mouth). On post operative days #12-13, patients will take one pill of propranolol XL 60 mg (once daily by mouth). This will complete the course of propranolol. | Drug | Propranolol Hydrochloride |
| PlaceboThe placebo pill will be taken for a total of 14 days. On the morning of the surgery, prior to entry into the operating room, patients will receive the first placebo pill to be taken once daily by mouth. On post operative days #1-13, patients will take one placebo pill (once daily by mouth). This will complete the course of the placebo. | Other | Placebo Group |
Primary outcome
ICU Length of Stay
Time frame: Truncated at 30 days after admission to ICU
Measured using patient medical records
Hospital Length of Stay
Time frame: Truncated at 30 days after admission to ICU
Measured using patient medical records
Postoperative Delirium
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 week
Measured using Confusion Assessment Method (CAM-CAM-ICU)
Postoperative Renal Dysfunction
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 week
Measured using Serum Creatinine laboratory values
13 secondary outcomes
Perioperative Complications
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 week
Pain Intensity
Time frame: 12 months
Pain Unpleasantness
Time frame: 12 months
Perioperative Opioids Use
Time frame: Participants will be followed from preoperative baseline to 1 year postoperative
Required Mechanical Ventilation
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 week
Change in Posttraumatic Diagnostic Scale (PDS) PTSD Symptoms Severity Score
Time frame: Baseline and 12 months
Change in Mental Component Summary (MCS) Scores From the Short Form-36 Questionnaire (SF-36)
Time frame: Participants will be followed from preoperative baseline to 1 year postoperative
Change in Physical Component Summary (PCS) Scores From the Short Form-36 Questionnaire (SF-36)
Time frame: Participants will be followed from preoperative baseline to 1 year postoperative
Change in Pittsburgh Sleep Quality Index (PSQI) Score
Time frame: Participants will be followed from preoperative baseline to 1 year postoperative
Change in Beck Depression Inventory (BDI) Score
Time frame: Participants will be followed from preoperative baseline to 1 year postoperative
Postoperative Neurocognitive Dysfunction Score
Time frame: Participants will be followed from preoperative baseline to 1 year postoperative
30-day, 3-month, and 1-year Mortality
Time frame: Participants will be followed from preoperative baseline to 1 year postoperative
Postoperative Complications
Time frame: Participants will be followed to 1 year postoperative
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marek Brzezinski, M.D., Ph.D. principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Propranolol Hydrochloride in people with Post-traumatic Stress Disorder, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICU Length of Stay (time frame: Truncated at 30 days after admission to ICU). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.