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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05741710
Recruitment Status : Recruiting
First Posted : February 23, 2023
Last Update Posted : March 28, 2024
Sponsor:
Information provided by (Responsible Party):
Transcend Therapeutics

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated 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])
Actual Study Start Date : March 1, 2023
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. Incidence of treatment-emergent adverse events (TEAEs) [ Time Frame: up to 10 weeks ]
    Type and rates of adverse events


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05741710


Contacts
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Contact: Study Director 650-769-6472 amanda@transcendtherapeutics.com

Locations
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Ireland
Tallaght Adult Mental Health Services Recruiting
Dublin, Ireland
Contact       ptsdresearch@crp.healthcare   
La Nua Day Hospital Mental Health Centre Recruiting
Galway, Ireland
Contact       abaker@crp.healthcare   
United Kingdom
Mirabilis Health Recruiting
Belfast, Northern Ireland, United Kingdom
Contact       info@mirabilishealth.co.uk   
Glasgow Clinical Research Facility, QEUH Recruiting
Glasgow, United Kingdom
Contact    0141 232 7599    ggc.mentalhealthresearch@ggc.scot.nhs.uk   
Clerkenwell Health Recruiting
London, United Kingdom
Contact: Study Coordinator    02038974860    participants@clerkenwellhealth.com   
St. Pancras Clinical Research Recruiting
London, United Kingdom
Contact       stuartratcliffe@stpancrasclinical.com   
Sponsors and Collaborators
Transcend Therapeutics
More Information
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Responsible Party: Transcend Therapeutics
ClinicalTrials.gov Identifier: NCT05741710    
Other Study ID Numbers: TT-TSND-201
First Posted: February 23, 2023    Key Record Dates
Last Update Posted: March 28, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Transcend Therapeutics:
methylone
PTSD
IMPACT-1
Transcend Therapeutics
Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders