An Evaluation of the Safety and Efficacy of Methylone for the Treatment of PTSD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-04

Study Completion Date

2025-09-23

Brief Summary

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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).

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Detailed Description

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Conditions

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Post Traumatic Stress Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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TSND-201 Low Dose

Part B only

Group Type EXPERIMENTAL

Methylone

Intervention Type DRUG

Methylone capsules, given orally, once a week for 3 weeks (Part A) or 4 weeks (Part B)

TSND-201 Mid Dose

Part B only

Group Type EXPERIMENTAL

Methylone

Intervention Type DRUG

Methylone capsules, given orally, once a week for 3 weeks (Part A) or 4 weeks (Part B)

TSND-201 High Dose

Part B only

Group Type EXPERIMENTAL

Methylone

Intervention Type DRUG

Methylone capsules, given orally, once a week for 3 weeks (Part A) or 4 weeks (Part B)

Interventions

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Methylone

Methylone capsules, given orally, once a week for 3 weeks (Part A) or 4 weeks (Part B)

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No