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Propranolol for Post-Traumatic Stress Disorder (PTTM Trial)
N/A
Waitlist Available
Led By Robin Menzies, MBBS FRCPsych (UK) FRCP (C)
Research Sponsored by Mela, Mansfield, M.D.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up visit 2 (week 4)
Awards & highlights
PTTM Trial Summary
This study will compare the responses of subjects with traumatic memories of varying vintages to either propranolol or placebo in a double-blind setting. It is hypothesized that those subjects who receive propranolol will experience less emotional distress when the memory is subsequently reactivated and less spontaneous re-experiences.
Eligible Conditions
- Post-Traumatic Stress Disorder
PTTM Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ visit 2 (week 4)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~visit 2 (week 4)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The primary endpoint will be changes between the pretreatment and posttreatment scores in the Clinician Assessment Posttraumatic Scale (CAPS), Impact of Event Scale (IES) and Traumatic Memory Description Measure (TMDM) instruments.
Secondary outcome measures
The secondary endpoint will be changes between the treatment and posttreatment score in the other scales used - MINI, ZAS, ZDS and NIHS.
PTTM Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: PropranololActive Control1 Intervention
The protocol of the study requires that two doses of propranolol (regular propranolol 40 mg followed two hours later by long-acting propranolol 60 mg) be given at the first visit, to be taken within one hour of the reactivation of the traumatic memory. Half of the subjects (33) will be randomized to receive propranolol.
Group II: PlaceboPlacebo Group1 Intervention
The protocol of the study requires that two doses of placebo be given at the first visit, to be taken within one hour of the reactivation of the traumatic memory. Half of the subjects (33) will be randomized to receive placebo.
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Who is running the clinical trial?
Mela, Mansfield, M.D.Lead Sponsor
Robin Menzies, MBBS FRCPsych (UK) FRCP (C)Principal Investigator
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