ISRCTN34308454已完成未知
Pre-reactivation propranolol therapy to reduce post-traumatic stress disorder in Nepalese torture survivors
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 46
研究概览
简要总结
2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34479508/ (added 06/09/2021)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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