Clinical TrialParallelPTSDMDMAPlaceboRecruiting

An Evaluation of the Safety and Efficacy of TSND-201 for the Treatment of PTSD (EMPOWER-1)

This Phase III, randomised, quadruple-blind, placebo-controlled trial (n=300) is evaluating TSND-201 (methylone) in adults with post-traumatic stress disorder. Participants are assigned in a 1:1:1 ratio to one of two TSND-201 dose levels or placebo, taken orally once a week for 4 consecutive weeks. The 4-week treatment period is followed by 8 weeks of observation. The primary outcome is change from baseline in Clinician-Administered PTSD Scale for DSM-5 total severity score through Week 12, with safety and tolerability assessed throughout treatment and follow-up.

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Target Enrollment
300 participants
Study Type
Phase III interventional
Design
Randomized, quadruple Blind

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Compound research: MDMATopic research: PTSDResearch in United States

Detailed Description

This study is evaluating the safety and efficacy of TSND-201 in adults with PTSD.

Eligible participants will enter a 4-week Treatment Period where they will be randomized 1:1:1 to receive one of two doses of TSND-201 or placebo, once per week. Following the Treatment Period, participants will enter an 8-week Follow-up Period.

Study Arms & Interventions

TSND-201, dose level 1

experimental

Interventions

  • MDMA
    via Oral• once weekly for 4 weeks• 4 doses total

    TSND-201 (methylone); represented under Blossom’s MDMA compound record.

TSND-201, dose level 2

experimental

Interventions

  • MDMA
    via Oral• once weekly for 4 weeks• 4 doses total

    TSND-201 (methylone); represented under Blossom’s MDMA compound record.

Placebo (matched to TSND-201)

inactive

Interventions

  • Placebo
    via Oral• once weekly for 4 weeks• 4 doses total

Participants

Ages
18 – ?
Sexes
Male & Female

Inclusion Criteria

  • Meets the DSM-5 criteria for current PTSD diagnosis, with a symptom duration of at least 6 months.
  • Tried at least one pharmacological treatment for PTSD or trauma-focused psychotherapy.
  • Proficient in communication (verbal and reading) to complete interviews and written 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.
  • Unable to refrain from nicotine use for at least 8 hours.
  • Use of prohibited concomitant medications or therapies.
  • Current or previous history of clinically significant cardiovascular (including current uncontrolled hypertension) / cerebrovascular conditions.

Study Protocol, Arms & Participants

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Study Details

  • Status
    Recruiting
  • Phase
    Phase III
  • Type
    interventional
  • Design
    Randomizedquadruple Blind
  • Target Enrollment300 participants
  • Timeline
    Start: 2026-04-02
    End: 2027-12-01
  • Compounds
    MDMAPlacebo
  • Topic
    PTSD

Study Team

Sponsors & Collaborators

Locations

Del Sol Research — Tucson, Arizona, United States
Preferred Research Partners — Little Rock, Arkansas, United States
Kadima Neuropsychiatry — La Jolla, California, United States
CalNeuro Research Group — Los Angeles, California, United States
Catalina Research Institute — Montclair, California, United States
Excell Research — Oceanside, California, United States
ATP Clinical Research — Orange, California, United States
Inland Psychiatric Medical Group — San Juan Capistrano, California, United States
Starlight Clinical Research — Evergreen, Colorado, United States
CNS Healthcare — Jacksonville, Florida, United States
Segal Trials — Lauderhill, Florida, United States
Accel Clinical Research — Maitland, Florida, United States
CNS Healthcare — Orlando, Florida, United States
Uptown Research Institute — Chicago, Illinois, United States
DelRicht - New Orleans — New Orleans, Louisiana, United States
Headlands Research - Pharmasite — Pikesville, Maryland, United States
Vitalix Clinical — Worcester, Massachusetts, United States
Arch Clinical Trials — Creve Coeur, Missouri, United States
Midwest Research Group — Saint Charles, Missouri, United States
Center for Emotional Fitness/ Lumina Clinical Research Center — Cherry Hill, New Jersey, United States
Global Medical Institutes — Princeton, New Jersey, United States
Bio Behavioral Health — Toms River, New Jersey, United States
Medical Research Network — New York, New York, United States
Insight Clinical Trials — Independence, Ohio, United States
Flourish Research — Plymouth Meeting, Pennsylvania, United States
Suburban Research Associates — West Chester, Pennsylvania, United States
Austin Clinical Trial Partners — Austin, Texas, United States
Haracec Clinical Research — El Paso, Texas, United States
Elevate Clinical Research — Houston, Texas, United States
Cedar Clinical Research — Draper, Utah, United States
Inner Space Research — Orem, Utah, United States
Seattle Neuropsychiatric Treatment Center (NTC) — Seattle, Washington, United States

Recent activity

  • StartedAn Evaluation of the Safety and Efficacy of TSND-201 for the Treatment of PTSD (EMPOWER-1) (NCT07456696, mdma)

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