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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Sponsor

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
TSND-201, Dose Level 1
  • Drug: TSND-201
    TSND-201 capsules, given orally, once a week for four consecutive weeks
    Other names:
    • methylone
Experimental
TSND-201, Dose Level 2
  • Drug: TSND-201
    TSND-201 capsules, given orally, once a week for four consecutive weeks
    Other names:
    • methylone
Placebo Comparator
Placebo
  • Drug: Placebo
    Placebo capsules, given orally, once a week for four consecutive weeks

Recruiting Locations

Preferred Research Partners
Little Rock, Arkansas 72211
Contact:
Study Coordinator

CNS Healthcare
Jacksonville, Florida 32256
Contact:
Study Coordinator
904-281-5757

CNS Healthcare
Orlando, Florida 32801
Contact:
Ashley Westerfeld
awesterfeld@cnshealthcare.com

More Details

Status
Recruiting
Sponsor
Transcend Therapeutics

Study Contact

Study Director
650-769-6472
empower-1@transcendtherapeutics.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.