IMPACT-1: A Study to Assess the Use of Methylone in the Treatment of PTSD

Sponsor

Transcend Therapeutics (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05741710

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Post Traumatic Stress Disorder	Drug: Methylone Drug: Placebo	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

79 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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])

Anticipated Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Methylone	Drug: Methylone Methylone capsules, given orally, once a week for 4 weeks
Placebo Comparator: Placebo	Drug: Placebo Placebo capsules to match methylone, given orally, once a week for 4 weeks. NOTE: Placebo is only in Part B

Arm

Intervention/Treatment

Experimental: Methylone

Drug: Methylone

Methylone capsules, given orally, once a week for 4 weeks

Placebo Comparator: Placebo

Drug: Placebo

Placebo capsules to match methylone, given orally, once a week for 4 weeks. NOTE: Placebo is only in Part B

Outcome Measures

Primary Outcome Measures

Change from Baseline in Clinician-Administered PTSD Scale for the DSM-5 (CAPS-5) total severity score [up to 10 weeks]
CAPS-5 is a structured interview designed to assess PTSD symptoms severity. The total severity score ranges from 0 to 80, with a higher score indicating more severe symptoms.

Secondary Outcome Measures

Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) total score [up to 10 weeks]
The MADRS is a 10-item, clinician-rated scale designed to assess severity of depression. The total score ranges from 0 to 60, with a higher score indicating more severe depression.
Change from Baseline in PTSD Checklist for DSM-5 (PCL-5) [up to 10 weeks]
The PCL-5 is a 20-item, patient-rated scale designed to measure severity of PTSD symptoms. The total score ranges from 0 to 80, with a higher score indicating more severe PTSD symptoms.
Change from Baseline in Sheehan Disability Scale (SDS) [up to 10 weeks]
The SDS is a 3-item, patient-rated scale designed to measure disability and impairment across three domains: work/school, social life, and family life / home responsibilities. Each domain is scored from 0 to 10, with higher scores represented more disability. Total sores range from 0 to 30.
Incidence of treatment-emergent adverse events (TEAEs) [up to 10 weeks]
Type and rates of adverse events

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.