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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06215261




Registration number
NCT06215261
Ethics application status
Date submitted
10/01/2024
Date registered
22/01/2024

Titles & IDs
Public title
An Evaluation of the Safety and Efficacy of Methylone for the Treatment of PTSD
Scientific title
An Evaluation of the Safety and Efficacy of Methylone for the Treatment of PTSD IMPACT-2 (Investigation of Methylone for Post-Traumatic Stress Disorder [PTSD])
Secondary ID [1] 0 0
TSND201-PTSD-202
Universal Trial Number (UTN)
Trial acronym
IMPACT-2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post Traumatic Stress Disorder 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Anxiety
Mental Health 0 0 0 0
Other mental health disorders
Mental Health 0 0 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Methylone

Experimental: TSND-201 Low Dose - Part B only

Experimental: TSND-201 Mid Dose - Part B only

Experimental: TSND-201 High Dose - Part B only


Treatment: Drugs: Methylone
Methylone capsules, given orally, once a week for 3 weeks (Part A) or 4 weeks (Part B)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from Baseline in Clinician-Administered PTSD Scale for the DSM-5 (CAPS-5) total severity score
Timepoint [1] 0 0
9 weeks (Part A) / 12 weeks (Part B)
Secondary outcome [1] 0 0
Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) total score
Timepoint [1] 0 0
9 weeks (Part A) / 12 weeks (Part B)
Secondary outcome [2] 0 0
Change from Baseline in PTSD Checklist for DSM-5 (PCL-5)
Timepoint [2] 0 0
9 weeks (Part A) / 12 weeks (Part B)
Secondary outcome [3] 0 0
Change from Baseline in Sheehan Disability Scale (SDS)
Timepoint [3] 0 0
9 weeks (Part A) / 12 weeks (Part B)
Secondary outcome [4] 0 0
Incidence of treatment-emergent adverse events (TEAEs)
Timepoint [4] 0 0
9 weeks (Part A) / 12 weeks (Part B)

Eligibility
Key inclusion criteria
* Meets DSM-5 criteria for severe PTSD diagnosis, with a symptom duration of at least 6 months.
* Tried 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.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Primary diagnosis of any other DSM-5 disorder.
* Body mass index (BMI) <18kg/m2 or =40 kg/m2.
* Smokes an average of >10 cigarettes and/or e-cigarettes per day.
* Uncontrolled hypertension at Screening.
* Use of prohibited concomitant medications or therapies.
* Current or previous history of clinically significant cardiovascular/cerebrovascular conditions.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/04/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2025
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Swinburne University of Technology - Hawthorn
Recruitment hospital [2] 0 0
Ramsay Clinic Albert Road - Melbourne
Recruitment hospital [3] 0 0
Monarch Mental Health Group - Melbourne
Recruitment postcode(s) [1] 0 0
3122 - Hawthorn
Recruitment postcode(s) [2] 0 0
3004 - Melbourne
Recruitment postcode(s) [3] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Illinois
Country [3] 0 0
United States of America
State/province [3] 0 0
Maryland
Country [4] 0 0
United States of America
State/province [4] 0 0
Nevada
Country [5] 0 0
United States of America
State/province [5] 0 0
Utah
Country [6] 0 0
United States of America
State/province [6] 0 0
Washington
Country [7] 0 0
United Kingdom
State/province [7] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Transcend Therapeutics
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Study Director
Address 0 0
Country 0 0
Phone 0 0
+1 (952) 250-7788
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06215261