Defeating the giant with a slingshot: testing a new technology to fight the global trauma epidemic

Not Applicable

Completed

• Conditions: Post-traumatic stress disorder; Mental and Behavioural Disorders

• Registration Number: ISRCTN34308454
• Lead Sponsor: Douglas Mental Health University Institute

Brief Summary

2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34479508/ (added 06/09/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-04-12
• Study Completion: 2019-02-01
• Last Update Posted: 20 September 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

1. Male or female 25-65 years old
2. Fluency in a Nepali language
3. Having experienced a potentially traumatic event according to the CAPS trauma list more than 6 months ago
4. Evidence of trauma-related distress, or impaired functioning, not present before the index event
5. Evidence that the candidate participant understands the study procedures
6. Signed informed consent form, OR a document signed by the site principal investigator attesting that consent was given orally in the presence of a witness

Exclusion Criteria

1. Resting heart rate < 60 Beats Per Minute
2. Resting systolic blood pressure < 100 mm Hg
3. A PCL score below 50.
4. A CGI severity score below 4 (Moderately ill)
5. Not meeting the criteria for chronic PTSD at the time of randomization (visit 2)
6. Currently suicidal (i.e. a score of 3 or 4 on item 7 on the HSCL) or homicidal
7. A history of congestive heart failure, hypoglycemic medication-requiring diabetes, chronic bronchitis, emphysema, or asthma
8. Acute morbidity that leads to disabilityand that requires immediate medical treatment (e.g., gastric acid disease)
9. Previous adverse reaction to a ß-adrenergic blocker
10. Presence of drugs of abuse, viz., alcohol, opiates, marijuana, cocaine, or amphetamines, as determined by collateral informants
11. Women of child-bearing potential who are not using an acceptable birth-control method, including abstinence (condoms will be provided for free)
12. Positive pregnancy test
13. Breastfeeding
14. Contra-indicating neuropsychiatric condition, e.g., current psychotic, bipolar, melancholic, memory problems or substance dependence or abuse disorder
15. Current use of medication that involve potentially dangerous interactions with propranolol, including, other ß-adrenergic blockers, anti-arrythmics, and calcium channel blockers
16. Potent P450 2D6 inhibitors will not be exclusionary, because participants will receive only a single day’s dose of propranolol under observation, so that build-up of plasma levels over time due to decreased metabolism will not be a problem
17. Current use of a medication that may involve potentially dangerous interactions with paroxetine, such as cimetidine, amitriptyline, desipramine, risperidone, atomoxetine, thioridazine, a MAOI, or pimozide

Study & Design

• Study Type: Interventional
• Study Design: Not specified