Posttraumatic Stress DisordersNCT00597389
Propranolol Administration and Prevention of Child PTSD in Child Trauma Victims
A study testing Inderol (propranolol) in people with Posttraumatic Stress Disorders, run by Kent State University.
Trial summary
Twenty-nine pediatric injury patients (ages 10-18) at risk for PTSD were randomly assigned to receive either propranolol or placebo in a double-blind placebo controlled design. Medication was initiated within 12 hours of hospital admission. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Posttraumatic Stress Disorders
- What is being tested?
- Inderol (propranolol)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- No sites listed yet
- Study dates
- Feb 2004to Feb 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Participants consisted of 15 male and 14 female accidental injury patients aged 10-18 recruited from the emergency department of Akron Children's Hospital. - Eligibility criteria included a Glasgow Coma Scale (GCS) score of 14 or greater (to permit informed consent) and an "at-risk" child score on the STEPP (Winston, Kassam-Adams, Garcia-Espana, Ittenbach, \& Cnaan, 2003), a screen for risk of PTSD.
Who cannot join
- Medication-specific exclusion criteria included hypersensitivity to beta-blockers
- Bradycardia
- Cardiogenic or hypovolemic shock
- Diabetes
- Preexisting heart condition; OR
- Treatment for asthma within the year prior to study entry (per Lacy, Armstrong, Goldman, \& Lance, 2002).
- Children were also excluded if they received epinephrine during emergency care or if they sustained any injuries precluding initiation of the propranolol regimen within 12 hours post-trauma.
About this study
Official title: The Efficacy of Early Propranolol Administration at Preventing/Reducing PTSD Symptoms in Child Trauma Victims: Pilot.
Twenty-nine pediatric injury patients (ages 10-18) at risk for PTSD were randomly assigned to receive either propranolol or placebo in a double-blind placebo controlled design. Medication was initiated within 12 hours of hospital admission. At 6-weeks, child PTSD symptoms and heart rate (HR) during trauma recall were assessed. We hypothesized that participants who received propranolol would report fewer PTSD symptoms and have lower heart rates than those who received placebo.
- Conditions
- Posttraumatic Stress Disorders
- Being tested
- Inderol (propranolol)
- Keywords
- posttraumatic stress disorder, propranolol, inderol, child, trauma, Posttraumatic stress disorders (PTSD)
- Medical subject headings
- Stress Disorders, Post-Traumatic, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inderol (propranolol)Drug
Also called propranolol
Children ingested a propranolol HCL 20 mg/5 ml solution twice daily for 10 days (and taper for 5 days). Medication was initiated within 12 hours post-trauma. Dose was calculated to be 2.5 mg/kg/d with a maximum dose of 40 mg.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | oral solution of propranolol (propranolol HCL 20 mg/5 ml solution) or a liquid placebo twice daily for 10 days (and taper for 5 days; based on Pitman et al, 2002). Dose was calculated as determined by Famularo et al. (1988) to be 2.5 mg/kg/d with a maximum dose of 40 mg bid (Green, 2001). Receives: Drug: Inderol (propranolol) |
| 2 | Placebo comparator | A 25/5ml solution of placebo (a sugar solution that looks and tastes like the propranolol solution) Receives: Drug: Inderol (propranolol) |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD symptoms with the Clinician Administered PTSD Scale for Children and Adolescents (CAPS-CA)
Measured: 6-week follow-up
Secondary outcomes (1)
cardiovascular reactivity during trauma description
Measured: at 6-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2008 (estimated)
- Study startFeb 2004
- Primary completionNov 2005
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Posttraumatic Stress DisordersStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kent State University
- Sponsor type
- University, hospital or other
- Collaborators
- Akron Children's Hospital, Ohio Board of Regents
- Investigators
- Douglas L Delahanty, PhD, Principal investigator, Kent State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00597389
- Sponsor's protocol ID
- 04-326
- Status last verified
- Jan 2008
- First submitted
- 9 Jan 2008
- Last updated
- 18 Jan 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
The efficacy of early propranolol administration at preventing/reducing PTSD symptoms in child trauma victims: Pilot. Nugent, Nicole Renee; Dissertation Abstracts International: Section B: The Sciences and Engineering, Vol 68(4-B), 2007. pp. 2665.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Early Propranolol Administration at Preventing/Reducing PTSD Symptoms in Child Trauma Victims: Pilot.
- ClinicalTrials.gov ID
- NCT00597389
- Acronym / sponsor ID
- 04-326
- Conditions
- Posttraumatic Stress Disorders
- Keywords
- posttraumatic stress disorder, propranolol, inderol, child, trauma, Posttraumatic stress disorders (PTSD)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Kent State UniversityUniversity, hospital or other
- Collaborators
- Akron Children's Hospital, Ohio Board of Regents
- Study start
- Feb 2004
- Primary completion
- Nov 2005 (actual)
- Study completion
- Feb 2006 (actual)
- First posted
- 18 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Twenty-nine pediatric injury patients (ages 10-18) at risk for PTSD were randomly assigned to receive either propranolol or placebo in a double-blind placebo controlled design. Medication was initiated within 12 hours of hospital admission. At 6-weeks, child PTSD symptoms and heart rate (HR) during trauma recall were assessed. We hypothesized that participants who received propranolol would report fewer PTSD symptoms and have lower heart rates than those who received placebo.
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 |
|---|---|---|
| 1 | Active comparator | Drug: Inderol (propranolol)oral solution of propranolol (propranolol HCL 20 mg/5 ml solution) or a liquid placebo twice daily for 10 days (and taper for 5 days; based on Pitman et al, 2002). Dose was calculated as determined by Famularo et al. (1988) to be 2.5 mg/kg/d with a maximum dose of 40 mg bid (Green, 2001). |
| 2 | Placebo comparator | Drug: Inderol (propranolol)A 25/5ml solution of placebo (a sugar solution that looks and tastes like the propranolol solution) |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Participants consisted of 15 male and 14 female accidental injury patients aged 10-18 recruited from the emergency department of Akron Children's Hospital. - Eligibility criteria included a Glasgow Coma Scale (GCS) score of 14 or greater (to permit informed consent) and an "at-risk" child score on the STEPP (Winston, Kassam-Adams, Garcia-Espana, Ittenbach, \& Cnaan, 2003), a screen for risk of PTSD.
Key exclusion criteria (7 listed)
- Medication-specific exclusion criteria included hypersensitivity to beta-blockers
- Bradycardia
- Cardiogenic or hypovolemic shock
- Diabetes
- Preexisting heart condition; OR
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 |
|---|---|---|
| Inderol (propranolol)Also: propranololChildren ingested a propranolol HCL 20 mg/5 ml solution twice daily for 10 days (and taper for 5 days). Medication was initiated within 12 hours post-trauma. Dose was calculated to be 2.5 mg/kg/d with a maximum dose of 40 mg. | Drug | 1, 2 |
Primary outcome
PTSD symptoms with the Clinician Administered PTSD Scale for Children and Adolescents (CAPS-CA)
Time frame: 6-week follow-up
1 secondary outcome
cardiovascular reactivity during trauma description
Time frame: at 6-week follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2008.
- Results publicationThe efficacy of early propranolol administration at preventing/reducing PTSD symptoms in child trauma victims: Pilot. Nugent, Nicole Renee; Dissertation Abstracts International: Section B: The Sciences and Engineering, Vol 68(4-B), 2007. pp. 2665.
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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.
Douglas L Delahanty, PhD principal investigator
Kent State University
Questions about this trial
What is this clinical trial studying?
A study testing Inderol (propranolol) in people with Posttraumatic Stress Disorders, run by Kent State University.
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: finished, as of the sponsor's last update on 18 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
PTSD symptoms with the Clinician Administered PTSD Scale for Children and Adolescents (CAPS-CA) (time frame: 6-week follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00597389, which also lists 1 linked publication.
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 18 Jan 2008.