Post-traumatic stress disorder Mental and Behavioural Disorders Post-traumatic stress disorder
Conditions
Interventions
This study aims to compare how well the memory reconsolidation blockade therapy works when compared to the current gold-standard in PTSD treatment: a selective serotonin reuptake inhibitor called paro
Sponsors
Douglas Mental Health University Institute
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The feasibility of memory reconsolidation blockade, measured by numbers of treatment completers, study adherence, and percentage of psychometric ratings completed, measured at one year after the recruitment start date 1. Traumatic events experienced, assessed using the clinician-administered PTSD scale (CAPS)-Trauma list at the first visit 2. Recalled peritraumatic responses, measured using the Peritraumatic Distress Inventory 3. PTSD symptoms, assessed using the self-report PTSD symptom checklist (PCL) prior to each traumatic memory reactivation session to cover the week elapsed since the last such session | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Axis I morbidity and comorbidity: general psychiatric comorbidity measured with the Nepali version of the Hopkins Symptom Checklist. The WHODAS-2 is a disability assessment instrument based on the conceptual framework of the International Classification of Functioning, Disability, and Health. It will provide a global measure of disability and seven domain-specific scores. These measures will be taken prior to the treatment and after the 6-week treatment has been completed. 2. Global clinical improvement associated with changes in mental health status, assessed at each visit with the Clinical Global Impression scale prior to treatment, at every treatment session (once per week for 6 weeks), and after the treatment has been completed 3. Quality of life, assessed using the WHO Quality of Life-BREF prior to the intervention and after the intervention has been completed | — |
Countries
Nepal
Contacts
Public ContactAlain Brunet
Outcome results
None listed