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

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ClinicalTrials.gov Identifier: NCT05741710
Recruitment Status : Recruiting
First Posted : February 23, 2023
Last Update Posted : June 11, 2024
Sponsor:
Information provided by (Responsible Party):
Transcend Therapeutics

Tracking Information
First Submitted Date  ICMJE February 13, 2023
First Posted Date  ICMJE February 23, 2023
Last Update Posted Date June 11, 2024
Actual Study Start Date  ICMJE March 1, 2023
Estimated Primary Completion Date December 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 13, 2023)
Change from Baseline in Clinician-Administered PTSD Scale for the DSM-5 (CAPS-5) total severity score [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 13, 2023)
  • Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) total score [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: up to 10 weeks ]
    Type and rates of adverse events
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Assess the Use of Methylone in the Treatment of PTSD
Official Title  ICMJE 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])
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Post Traumatic Stress Disorder
Intervention  ICMJE
  • Drug: Methylone
    Methylone capsules, given orally, once a week for 4 weeks
  • Drug: Placebo
    Placebo capsules to match methylone, given orally, once a week for 4 weeks. NOTE: Placebo is only in Part B
Study Arms  ICMJE
  • Experimental: Methylone
    Intervention: Drug: Methylone
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 13, 2023)
79
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2024
Estimated Primary Completion Date December 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Study Director 650-769-6472 amanda@transcendtherapeutics.com
Listed Location Countries  ICMJE Ireland,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05741710
Other Study ID Numbers  ICMJE TT-TSND-201
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Transcend Therapeutics
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Transcend Therapeutics
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Transcend Therapeutics
Verification Date June 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP