Ignite Creation Date:
2024-05-06 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 12:53 PM
Study NCT ID:
NCT03652922
Status:
UNKNOWN
Last Update Posted:
2018-08-29
First Post:
2018-08-22
Brief Title:
Propranolol Reactivation Mismatch PRM Treatment for PTSD
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Propranolol Reactivation Mismatch PRM Treatment for PTSD A Pilot Study
Status:
UNKNOWN
Status Verified Date:
2018-08
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of the proposed work is to gather pilot data from an attempt to enhance the ability of propranolol reactivation PR to improve PTSD symptoms by incorporating into the design a mismatch PRM between what is expected and what occurs while a subject reads a narrative of the traumatic event that caused their PTSD under the influence of the ß-adrenergic blocking drug propranolol It is hypothesized that a series of PRM treatments will produce superior symptomatic decreases compared to what the investigators have found in prior published studies using PR without mismatch
Under certain circumstances retrieval reactivation of a traumatic memory returns it to a deconsolidated state from which it must be reconsolidated if it is to persist Concomitant administration of the ß-adrenergic blocker weakens a deconsolidated traumatic memory and reduces PTSD symptoms presumably through blockade of reconsolidation It has recently been discovered that in order for deconsolidation to occur there must be a mismatch between what is expected and what actually occurs Altering the context in which a traumatic memory is retrieved putatively represents a deconsolidation-promoting mismatch Experimentally increasing mismatch by manipulating context may make propranolol more effective in the treatment of PTSD
The design is a single-blind placebo-controlled randomized PRM clinical trial by Partners researchers in 11 convenience pilot subjects between ages 18 and 65 with active PTSD using a 101 propranololplacebo randomization schedule This two-month study will have the following components Pre-treatment psychometric evaluation Treatment consisting of six weekly PRM sessions with propranolol or placebo Post-treatment psychometric evaluation Six-month follow-up psychometric evaluation The Clinician-Administered PTSD Scale CAPS and PTSD Checklist PCL will be administered at pre- and post-treatment and at follow-up The Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders-fifth edition DSM-5 will also be administered at the pre-treatment evaluation The PCL will also be administered prior to each weekly treatment session
Pilot data analysis will consist of calculation of percent improvements and effect sizes in CAPS-5 and PCL-5 scores observational comparisons with results obtained without mismatch in prior published studies informal statistical comparisons via t-tests and calculation of effect sizes for power analysis for a subsequent definitive study if indicated
Under certain circumstances retrieval reactivation of a traumatic memory returns it to a deconsolidated state from which it must be reconsolidated if it is to persist Concomitant administration of the ß-adrenergic blocker weakens a deconsolidated traumatic memory and reduces PTSD symptoms presumably through blockade of reconsolidation It has recently been discovered that in order for deconsolidation to occur there must be a mismatch between what is expected and what actually occurs Altering the context in which a traumatic memory is retrieved putatively represents a deconsolidation-promoting mismatch Experimentally increasing mismatch by manipulating context may make propranolol more effective in the treatment of PTSD
The design is a single-blind placebo-controlled randomized PRM clinical trial by Partners researchers in 11 convenience pilot subjects between ages 18 and 65 with active PTSD using a 101 propranololplacebo randomization schedule This two-month study will have the following components Pre-treatment psychometric evaluation Treatment consisting of six weekly PRM sessions with propranolol or placebo Post-treatment psychometric evaluation Six-month follow-up psychometric evaluation The Clinician-Administered PTSD Scale CAPS and PTSD Checklist PCL will be administered at pre- and post-treatment and at follow-up The Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders-fifth edition DSM-5 will also be administered at the pre-treatment evaluation The PCL will also be administered prior to each weekly treatment session
Pilot data analysis will consist of calculation of percent improvements and effect sizes in CAPS-5 and PCL-5 scores observational comparisons with results obtained without mismatch in prior published studies informal statistical comparisons via t-tests and calculation of effect sizes for power analysis for a subsequent definitive study if indicated
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None