Post-Traumatic Stress DisorderPhase 4NCT00648375
Effectiveness of Propranolol For Treating People With Post-Traumatic Stress Disorder
A Phase 4 study testing Propanolol and Cognitive therapy workbook in people with Post-Traumatic Stress Disorder, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
This study will evaluate the effectiveness of propranolol in reducing symptoms of distress in people with post-traumatic stress disorder. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Post-Traumatic Stress Disorder
- What is being tested?
- Propanolol and Cognitive therapy workbook
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2003to Sep 2009
- 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- DSM-IV diagnosis of PTSD or meets the five of the six diagnostic criteria for PTSD (event, hyperarousal, re-experiencing, duration, and distress/impaired functioning symptom criteria), but not the avoidance/numbing symptom criteria
Who cannot join
- Past or current asthma
- Diabetes or heart disease
- Currently pregnant or breastfeeding
- Concurrent use of daily benzodiazepine; daily use of antidepressant medication allowed if dose has been stable for the 3 months before study entry
- Exposure therapy or additional cognitive therapy during the course of the study (supportive psychotherapy is allowed if ongoing for at least 3 months before study entry)
- Substance abuse
- Current use of beta blockers, amiodarone, chlorpromazine, cimetidine, clonidine, or digoxin
Trial locations and contacts
1 site in 1 country.
United States1 site
Weill Cornell Medical College
New York, New York, 10065
About this study
Official title: Efficacy of Propanolol for Treatment of Posttraumatic Stress Disorder
This study will evaluate the effectiveness of propranolol in reducing symptoms of distress in people with post-traumatic stress disorder.
Read the detailed description
Post-traumatic stress disorder (PTSD) is a common and disabling condition, with about 10% of people having experienced PTSD at some point during their lives. The diagnosis of PTSD requires certain criteria: exposure to a severe psychological trauma and the persistent presence of three symptom clusters that include re-experiencing the traumatic event, physiologic hyperarousal, and emotional numbing paired with avoidance of stimuli associated with the event. Stimuli and cues associated with the trauma, such as features of an assailant or accident site, can cause a person to re-experience the traumatic memory and associated feelings of helplessness and fear. When re-experiencing a traumatic memory, people with PTSD usually undergo a heightened stress-related hormonal response that further solidifies new stimulating associations with the traumatic memory. Treatment with propranolol, a blood pressure-lowering drug that reduces stress-related hormonal responses, may be an effective means of preventing the formation of traumatic memories and of improving PTSD symptoms. This study will evaluate the effectiveness of propranolol in reducing symptoms of distress associated with traumatic memories in people with PTSD.
Participation in this study will last 14 weeks. All potential participants will undergo a 4-hour initial visit that will begin with a medical and psychiatric history review, a psychiatric interview, and symptom questionnaires. Participants will then be assigned randomly to take a test dose of either propranolol or placebo. Upon completion of the test dose, participants will begin 14 weeks of treatment with their assigned test dose medication. Participants will be asked to take the study medication each time they have a traumatic memory associated with hyperarousal symptoms, but no more than two times a day. Using a cognitive behavioral therapy based-workbook, participants will track their symptoms daily and when they use cognitive techniques to relieve symptoms.
Participants will attend study visits every 2 weeks for the 14 weeks of treatment. During these visits, participants will describe any side effects experienced, complete interviews and questionnaires about PTSD symptom severity, review with study officials their daily workbook entries, and pick up medication. Study participation will end upon completion of the Week 14 study visit.
For information on a related study, please follow this link:
http://clinicaltrials.gov/show/NCT00391430
- Conditions
- Post-Traumatic Stress Disorder
- Being tested
- Propanolol, Placebo, Cognitive therapy workbook
- Keywords
- Propanolol, Beta Blockers, Reconsolidation, Cognitive Therapy, PTSD
- 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.
PropanololDrug
Also called Inderal
Participants will take a 40-mg dose of propranolol immediately after they experience a traumatic memory associated with strong hyperarousal symptoms. Participants may take up to two doses a day, if the doses are separated by at least 6 hours.
PlaceboDrug
Participants will take a single dose of placebo immediately after they experience a traumatic memory associated with strong hyperarousal symptoms. Participants may take up to two doses a day, if the doses are separated by at least 6 hours.
Cognitive therapy workbookBehavioural
Participants will also receive a cognitive behavioral therapy-based workbook in which they will track symptoms and efforts to use cognitive techniques to relieve symptoms each day.
| Study group | Role | What they receive |
|---|---|---|
| Propranolol | Experimental | Participants will take propranolol for 14 weeks. Medication will be self-administered times they experience acute onset of hyperarousal symptoms, not more than twice per day. Receives: Drug: Propanolol; Behavioral: Cognitive therapy workbook |
| Placebo | Placebo comparator | Participants will take placebo for 14 weeks. Medication will be self-administered times they experience acute onset of hyperarousal symptoms, not more than twice per day. Receives: Drug: Placebo; Behavioral: Cognitive therapy workbook |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Severity of PTSD Symptoms Measured by Clinician Administered PTSD Scale for DSM-IV (CAPS-DX)
Scores range from 0-70, higher scores represent more severe symptoms
Measured: Measured at Week 0, 2,4,6,8,10,12,14
Secondary outcomes (3)
Change in Depression Measured by Beck Depression Inventory (BDI)
Scores range from 0-30, higher scores represent more severe symptoms
Measured: Measured at Weeks 0,2,4,6,8,10,12, 14
Change in Post-traumatic Scale-Self Score (PS-SR)
This is a 17-item self-report scale. Scores range from 0-51, higher scores represent more severe symptoms.
Measured: Measured at Weeks 0,2,4,6,8,10,12, 14
Change in Brief Symptoms Inventory-Short Form (BSI-SF)
BSI-SF is an 18 item scale used for a global score of general distress. Scores range from 0-72, higher scores represent more severe symptoms
Measured: Measured at Weeks 0,2,4,6,8,10,12, 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2008 (estimated)
- Study startDec 2003
- Primary completionJun 2009
- Study completionSep 2009
Why it stopped: inadequate recruitment
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 Weill Medical College of Cornell UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Margaret Altemus, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00648375
- Sponsor's protocol ID
- P50MH058911-01
- Other IDs
- P50MH058911-01, 0305006139
- Status last verified
- Dec 2019
- First submitted
- 28 Mar 2008
- Last updated
- 2 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Propanolol for Treatment of Posttraumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT00648375
- Acronym / sponsor ID
- P50MH058911-01
- Conditions
- Post-Traumatic Stress Disorder
- Keywords
- Propanolol, Beta Blockers, Reconsolidation, Cognitive Therapy, PTSD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: inadequate recruitment
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Dec 2003
- Primary completion
- Jun 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 1 Apr 2008 (estimated)
- Results
- Posted 2 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the effectiveness of propranolol in reducing symptoms of distress in people with post-traumatic stress disorder.
Detailed description
Post-traumatic stress disorder (PTSD) is a common and disabling condition, with about 10% of people having experienced PTSD at some point during their lives. The diagnosis of PTSD requires certain criteria: exposure to a severe psychological trauma and the persistent presence of three symptom clusters that include re-experiencing the traumatic event, physiologic hyperarousal, and emotional numbing paired with avoidance of stimuli associated with the event. Stimuli and cues associated with the trauma, such as features of an assailant or accident site, can cause a person to re-experience the traumatic memory and associated feelings of helplessness and fear. When re-experiencing a traumatic memory, people with PTSD usually undergo a heightened stress-related hormonal response that further solidifies new stimulating associations with the traumatic memory. Treatment with propranolol, a blood pressure-lowering drug that reduces stress-related hormonal responses, may be an effective means of preventing the formation of traumatic memories and of improving PTSD symptoms. This study will evaluate the effectiveness of propranolol in reducing symptoms of distress associated with traumatic memories in people with PTSD.
Participation in this study will last 14 weeks. All potential participants will undergo a 4-hour initial visit that will begin with a medical and psychiatric history review, a psychiatric interview, and symptom questionnaires. Participants will then be assigned randomly to take a test dose of either propranolol or placebo. Upon completion of the test dose, participants will begin 14 weeks of treatment with their assigned test dose medication. Participants will be asked to take the study medication each time they have a traumatic memory associated with hyperarousal symptoms, but no more than two times a day. Using a cognitive behavioral therapy based-workbook, participants will track their symptoms daily and when they use cognitive techniques to relieve symptoms.
Participants will attend study visits every 2 weeks for the 14 weeks of treatment. During these visits, participants will describe any side effects experienced, complete interviews and questionnaires about PTSD symptom severity, review with study officials their daily workbook entries, and pick up medication. Study participation will end upon completion of the Week 14 study visit.
For information on a related study, please follow this link:
http://clinicaltrials.gov/show/NCT00391430
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propranolol | Experimental | Drug: Propanolol, Behavioral: Cognitive therapy workbookParticipants will take propranolol for 14 weeks. Medication will be self-administered times they experience acute onset of hyperarousal symptoms, not more than twice per day. |
| Placebo | Placebo comparator | Drug: Placebo, Behavioral: Cognitive therapy workbookParticipants will take placebo for 14 weeks. Medication will be self-administered times they experience acute onset of hyperarousal symptoms, not more than twice per day. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- DSM-IV diagnosis of PTSD or meets the five of the six diagnostic criteria for PTSD (event, hyperarousal, re-experiencing, duration, and distress/impaired functioning symptom criteria), but not the avoidance/numbing symptom criteria
Key exclusion criteria (7 listed)
- Past or current asthma
- Diabetes or heart disease
- Currently pregnant or breastfeeding
- Concurrent use of daily benzodiazepine; daily use of antidepressant medication allowed if dose has been stable for the 3 months before study entry
- Exposure therapy or additional cognitive therapy during the course of the study (supportive psychotherapy is allowed if ongoing for at least 3 months before study entry)
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 |
|---|---|---|
| PropanololAlso: InderalParticipants will take a 40-mg dose of propranolol immediately after they experience a traumatic memory associated with strong hyperarousal symptoms. Participants may take up to two doses a day, if the doses are separated by at least 6 hours. | Drug | Propranolol |
| PlaceboParticipants will take a single dose of placebo immediately after they experience a traumatic memory associated with strong hyperarousal symptoms. Participants may take up to two doses a day, if the doses are separated by at least 6 hours. | Drug | Placebo |
| Cognitive therapy workbookParticipants will also receive a cognitive behavioral therapy-based workbook in which they will track symptoms and efforts to use cognitive techniques to relieve symptoms each day. | Behavioural | Placebo, Propranolol |
Primary outcome
Change in Severity of PTSD Symptoms Measured by Clinician Administered PTSD Scale for DSM-IV (CAPS-DX)
Time frame: Measured at Week 0, 2,4,6,8,10,12,14
Scores range from 0-70, higher scores represent more severe symptoms
3 secondary outcomes
Change in Depression Measured by Beck Depression Inventory (BDI)
Time frame: Measured at Weeks 0,2,4,6,8,10,12, 14
Change in Post-traumatic Scale-Self Score (PS-SR)
Time frame: Measured at Weeks 0,2,4,6,8,10,12, 14
Change in Brief Symptoms Inventory-Short Form (BSI-SF)
Time frame: Measured at Weeks 0,2,4,6,8,10,12, 14
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Post-Traumatic Stress Disorder
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Not yet recruitingPhase 3
Women Who Are Victims of Violence: Treatment of PTSD Through Reactivation of Traumatic Memories Using Propranolol
Post-Traumatic Stress Disorder, PTSD
RecruitingPhase 4
The Effects of Orexin Antagonism on Fear Extinction in PTSD
Insomnia, PTSD
Recruiting
Advancing Skills Through Consultation, Education, and Novel Technologies
PTSD - Post Traumatic Stress Disorder
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.
Margaret Altemus, MD principal investigator
Weill Medical College of Cornell University
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 Propanolol and Cognitive therapy workbook in people with Post-Traumatic Stress Disorder, run by Weill Medical College of Cornell University 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 1 inclusion and 7 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 Jan 2020. 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 Jan 2020). 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?
Change in Severity of PTSD Symptoms Measured by Clinician Administered PTSD Scale for DSM-IV (CAPS-DX) (time frame: Measured at Week 0, 2,4,6,8,10,12,14). 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 Jan 2020.