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

Primary Purpose

Post Traumatic Stress Disorder

Status
Recruiting
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
Methylone
Placebo
Sponsored by
Transcend Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Traumatic Stress Disorder focused on measuring methylone, PTSD, IMPACT-1, Transcend Therapeutics

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mirabilis HealthRecruiting
  • Clerkenwell HealthRecruiting
  • St. Pancras Clinical ResearchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Methylone

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Change from Baseline in Clinician-Administered PTSD Scale for the DSM-5 (CAPS-5) total severity score
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

Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) total score
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)
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)
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)
Type and rates of adverse events

Full Information

First Posted
February 13, 2023
Last Updated
June 30, 2023
Sponsor
Transcend Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT05741710
Brief Title
A Study to Assess the Use of Methylone in the Treatment of PTSD
Acronym
IMPACT-1
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])
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Transcend Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Traumatic Stress Disorder
Keywords
methylone, PTSD, IMPACT-1, Transcend Therapeutics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
79 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Methylone
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Methylone
Intervention Description
Methylone capsules, given orally, once a week for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo capsules to match methylone, given orally, once a week for 4 weeks. NOTE: Placebo is only in Part B
Primary Outcome Measure Information:
Title
Change from Baseline in Clinician-Administered PTSD Scale for the DSM-5 (CAPS-5) total severity score
Description
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.
Time Frame
up to 10 weeks
Secondary Outcome Measure Information:
Title
Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) total score
Description
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.
Time Frame
up to 10 weeks
Title
Change from Baseline in PTSD Checklist for DSM-5 (PCL-5)
Description
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.
Time Frame
up to 10 weeks
Title
Change from Baseline in Sheehan Disability Scale (SDS)
Description
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.
Time Frame
up to 10 weeks
Title
Incidence of treatment-emergent adverse events (TEAEs)
Description
Type and rates of adverse events
Time Frame
up to 10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Director
Phone
650-769-6472
Email
amanda@transcendtherapeutics.com
Facility Information:
Facility Name
Mirabilis Health
City
Belfast
State/Province
Northern Ireland
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
Email
info@mirabilishealth.co.uk
Facility Name
Clerkenwell Health
City
London
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
02038974860
Email
participants@clerkenwellhealth.com
Facility Name
St. Pancras Clinical Research
City
London
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
Email
stuartratcliffe@stpancrasclinical.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Study to Assess the Use of Methylone in the Treatment of PTSD

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