Clinical trial NCT05741710: A Study to Assess the Use of Methylone in the Treatment of PTSD
Official title: 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])
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Post Traumatic Stress Disorder
Keywords: methylone
PTSD
IMPACT-1
Transcend Therapeutics
Lead sponsor: Transcend Therapeutics
Sponsor class: INDUSTRY
First posted: 2023-02-23
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
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, tolerability, and efficacy of methylone in adults with PTSD. The study will be conducted in two parts.

* Part A is open-label and will enroll up to 15 participants with PTSD
* Part B is randomized (1:1), double-blind, placebo-controlled and will enroll up to 64 participants with PTSD

Eligible participants will enter a 4-week Treatment Period where they will receive methylone once weekly for 4 weeks (4 treatment sessions). Following the Treatment Period, participants will enter a 6-week Follow-up Period which includes 3 reflection visits (Week 4, 5, and 6) and a final study visit at Week 10.


Eligibility criteria: Inclusion Criteria:

* Meets the DSM-5 criteria for current moderate to severe PTSD diagnosis, with a symptom duration of at least 6 months
* CAPS-5 score of ≥35 at Screening.
* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change from Baseline in Clinician-Administered PTSD Scale for the DSM-5 (CAPS-5) total severity score
timeFrame: up to 10 weeks
Secondary outcomes:
measure: Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) total score
timeFrame: up to 10 weeks
measure: Change from Baseline in PTSD Checklist for DSM-5 (PCL-5)
timeFrame: up to 10 weeks
measure: Change from Baseline in Sheehan Disability Scale (SDS)
timeFrame: up to 10 weeks
measure: Incidence of treatment-emergent adverse events (TEAEs)
timeFrame: up to 10 weeks
Other outcomes:
Locations:
city: Denver
country: United States
facility: Mountain View Clinical Research
state: Colorado
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions - Jacksonville
state: Florida
city: Maitland
country: United States
facility: Accel Research Sites
state: Florida
city: Rockville
country: United States
facility: Sunstone Therapies
state: Maryland
city: Boston
country: United States
facility: Boston Clinical Trials
state: Massachusetts
city: Berlin
country: United States
facility: Cenexel HRI
state: New Jersey
city: Oklahoma City
country: United States
facility: The Rivus Wellness & Research Institute
state: Oklahoma
city: Murray
country: United States
facility: Cedar Clinical Research
state: Utah
city: Dublin
country: Ireland
facility: Tallaght Adult Mental Health Services
city: Galway
country: Ireland
facility: La Nua Day Hospital Mental Health Centre
city: Belfast
country: United Kingdom
facility: Mirabilis Health
state: Northern Ireland
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospitals NHS Foundation Trust
city: Glasgow
country: United Kingdom
facility: Glasgow Clinical Research Facility, QEUH
city: London
country: United Kingdom
facility: Clerkenwell Health
city: London
country: United Kingdom
facility: King's College
city: Oxford
country: United Kingdom
facility: Oxford Health NHS Foundation Trust
Study officials:
References: