A Pilot Study to Assess the Use of Methylone in the Treatment of PTSD IMPACT-1 (Investigation of Methylone for Post-Traumatic Stress Disorder [PTSD])
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Part A: Incidence and severity of TEAEs.
研究概览
简要总结
PART A: To assess the safety and tolerability of oral methylone administered weekly over 4 weeks in participants with PTSD. PART:B: To assess the efficacy of methylone in treating PTSD symptoms.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Meets the DSM-5 criteria for current moderate to severe PTSD diagnosis, with a symptom duration of at least 6 months. (The PTSD diagnosis will be confirmed at Baseline by the central rater).
- •CAPS-5 score of ‚ ≥35 at Screening and ≥28 at Baseline.
- •Failed at least one treatment for PTSD (either psychotherapy or pharmacological treatment).
- •Proficient in reading and writing in local language sufficient to complete questionnaires.
- •Free from any other clinically significant illness or disease
排除标准
- •Primary diagnosis of any other DSM-5 disorder
- •Body mass index (BMI) <18 kg/m2 or ‚≥40 kg/m2
- •Smokes an average of >10 cigarettes and/or e-cigarettes per day
- •Uncontrolled hypertension at Screening
- •Use of a psychedelic (e.g., LSD, psilocybin, DMT, mescaline), or entactogens such as MDMA, within 12 months of Screening.
- •Use of an SSRI or other antidepressant within 8 weeks of screening
- •Current or previous history of clinically significant cardiovascular/cerebrovascular conditions
结局指标
主要结局
Part A: Incidence and severity of TEAEs.
Part A: Incidence and severity of TEAEs.
Part A: Incidence and severity of AESIs.
Part A: Incidence and severity of AESIs.
Part A: Change in HR, SBP, DBP and temperature
Part A: Change in HR, SBP, DBP and temperature
Part A: Clinically significant changes in ECG.
Part A: Clinically significant changes in ECG.
Part A: Changes from baseline in clinical laboratory parameters (clinical chemistry, haematology and urinalysis).
Part A: Changes from baseline in clinical laboratory parameters (clinical chemistry, haematology and urinalysis).
Part B: Mean change from baseline to Week 10 compared with placebo in CAPS-5 total severity score.
Part B: Mean change from baseline to Week 10 compared with placebo in CAPS-5 total severity score.
次要结局
- Part B: Percentage of participants having: - Treatment response, defined as a a. ≥ 10 point reduction on the CAPS-5 from baseline b. 30% improvement from baseline on CAPS-5 c. 50% improvement from baseline on CAPS-5 - Remission, defined as a score of ≤ 11 on the CAPS-5 - Improvement on the PGI-C - Improvement on the CGI-I
- Part B: Incidence and severity of TEAEs
- Part B: Incidence and severity of AESIs
- Part B: Change in HR, SBP, DBP and temperature during each dosing session
- Part B: Clinically significant changes in ECG
- Part B: Changes from baseline in clinical laboratory parameters (clinical chemistry, haematology, and urinalysis)
- Part A: Mean change from baseline to week 10 in CAPS-5 (total severity score assessed over 1 week)
- Part A: Percentage of participants having: - Treatment response, defined as a a. ≥ 10 point reduction on the CAPS-5 from baseline b. 30% improvement from baseline on CAPS-5 c. 50% improvement from baseline on CAPS-5 - Remission, defined as a score of ≤ 11 on the CAPS-5
- Part A: Mean change from baseline in the following scales: - CGI-S - MADRS - SDS - PCL-5 - PGI-S - BDI-II - WEMWBS - PSQI
- Part A: Percentage of participants with improvement on the following scales: - PGI-C -CGI-I
- Part B: Mean change from baseline compared with placebo in the following scales: - CGI-S - MADRS - SDS - PCL-5 - PGI-S - BDI-II - WEMWBS - PSQI
研究者
Amanda Jones
Scientific
Transcend Therapeutics Inc.