Effectiveness of Propranolol For Treating People With Post-Traumatic Stress Disorder

NCT00648375 | Terminated Phase 4 Results

• 2 other identifiers: P50MH058911-010305006139
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the effectiveness of propranolol in reducing symptoms of distress in people with post-traumatic stress disorder.

Conditions

Post-Traumatic Stress Disorder

Keywords

Propanolol; Beta Blockers; Reconsolidation; Cognitive Therapy; PTSD

Outcome Measures

Primary Outcomes (1)

• 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 at Week 0, 2,4,6,8,10,12,14

Secondary Outcomes (3)

• Change in Depression Measured by Beck Depression Inventory (BDI)

  Measured at Weeks 0,2,4,6,8,10,12, 14

• Change in Post-traumatic Scale-Self Score (PS-SR)

  Measured at Weeks 0,2,4,6,8,10,12, 14

• Change in Brief Symptoms Inventory-Short Form (BSI-SF)

  Measured at Weeks 0,2,4,6,8,10,12, 14

Study Arms (2)

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.

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.

Drug: Placebo; Behavioral: Cognitive therapy workbook

Interventions

Propanolol DRUG

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.

Also known as: Inderal

Propranolol

Placebo DRUG

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.

Placebo

Cognitive therapy workbook BEHAVIORAL

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.

Placebo; Propranolol

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Weill Cornell Medical College

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Propranolol

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Limitations and Caveats

Due to small numbers of subjects in both arms, statistical analyses were not possible.

Results Point of Contact

• Title: Margaret Altemus
• Organization: Yale School of Medicine

margaret.altemus@yale.edu

646-209-6277

Study Officials

• Margaret Altemus, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2008
• First Posted: April 1, 2008
• Study Start: December 1, 2003
• Primary Completion: June 1, 2009
• Study Completion: September 1, 2009
• Last Updated: January 2, 2020
• Results First Posted: January 2, 2020

Record last verified: 2019-12

Locations

US (1)