Clinical trial NCT06215261: An Evaluation of the Safety and Efficacy of Methylone for the Treatment of PTSD
Official title: An Evaluation of the Safety and Efficacy of Methylone for the Treatment of PTSD IMPACT-2 (Investigation of Methylone for Post-Traumatic Stress Disorder [PTSD])
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Post Traumatic Stress Disorder
Keywords: Methylone
IMPACT-2
PTSD
Neuroplastogen
TSND-201
Lead sponsor: Transcend Therapeutics
Sponsor class: INDUSTRY
First posted: 2024-01-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is evaluating the safety and efficacy of methylone in adults with PTSD. The study is conducted in two parts.

* Part A is open-label and will enroll up to 15 participants with PTSD
* Part B is randomized (1:1:1), single-blind and will enroll up to 45 participants with PTSD

Eligible participants will enter a 3-week Treatment Period (Part A) or 4-week Treatment Period (Part B) where they will receive methylone once weekly. Following the Treatment Period, participants will enter a 6-week Follow-up Period (Part A) or 8-week Follow-up Period (Part B).


Eligibility criteria: Inclusion Criteria:

* Meets DSM-5 criteria for severe PTSD diagnosis, with a symptom duration of at least 6 months.
* Tried 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.

Exclusion Criteria:

* Primary diagnosis of any other DSM-5 disorder.
* Body mass index (BMI) \<18kg/m2 or ≥40 kg/m2.
* Smokes an average of \>10 cigarettes and/or e-cigarettes per day.
* Uncontrolled hypertension at Screening.
* Use of prohibited concomitant medications or therapies.
* Current or previous history of clinically significant cardiovascular/cerebrovascular conditions.

Primary outcomes:
measure: Change from Baseline in Clinician-Administered PTSD Scale for the DSM-5 (CAPS-5) total severity score
timeFrame: 9 weeks (Part A) / 12 weeks (Part B)
Secondary outcomes:
measure: Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) total score
timeFrame: 9 weeks (Part A) / 12 weeks (Part B)
measure: Change from Baseline in PTSD Checklist for DSM-5 (PCL-5)
timeFrame: 9 weeks (Part A) / 12 weeks (Part B)
measure: Change from Baseline in Sheehan Disability Scale (SDS)
timeFrame: 9 weeks (Part A) / 12 weeks (Part B)
measure: Incidence of treatment-emergent adverse events (TEAEs)
timeFrame: 9 weeks (Part A) / 12 weeks (Part B)
Other outcomes:
Locations:
city: Lauderhill
country: United States
facility: Segal Trials
state: Florida
city: Maitland
country: United States
facility: Accel Research
state: Florida
city: Orlando
country: United States
facility: CNS Healthcare
state: Florida
city: Chicago
country: United States
facility: Uptown Clinical Research
state: Illinois
city: Rockville
country: United States
facility: Sunstone Medical
state: Maryland
city: Las Vegas
country: United States
facility: Redbird Research LLC
state: Nevada
city: Draper
country: United States
facility: Numinus
state: Utah
city: Bellevue
country: United States
facility: Seattle NTC
state: Washington
city: Hawthorn
country: Australia
facility: Swinburne University of Technology
state: Victoria
city: Melbourne
country: Australia
facility: Ramsay Clinic Albert Road
state: Victoria
city: Melbourne
country: Australia
facility: Monarch Mental Health Group
state: Victoria
city: London
country: United Kingdom
facility: Clerkenwell Health
Study officials:
References: