Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05741710
Other study ID # TT-TSND-201
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date March 1, 2023
Est. completion date December 2024

Study information

Verified date June 2024
Source Transcend Therapeutics
Contact Study Director
Phone 650-769-6472
Email amanda@transcendtherapeutics.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 79
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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.

Study Design


Intervention

Drug:
Methylone
Methylone capsules, given orally, once a week for 4 weeks
Placebo
Placebo capsules to match methylone, given orally, once a week for 4 weeks. NOTE: Placebo is only in Part B

Locations

Country Name City State
Ireland Tallaght Adult Mental Health Services Dublin
Ireland La Nua Day Hospital Mental Health Centre Galway
United Kingdom Mirabilis Health Belfast Northern Ireland
United Kingdom Cambridge University Hospitals NHS Foundation Trust Cambridge
United Kingdom Glasgow Clinical Research Facility, QEUH Glasgow
United Kingdom Clerkenwell Health London
United Kingdom King's College London
United Kingdom St. Pancras Clinical Research London

Sponsors (1)

Lead Sponsor Collaborator
Transcend Therapeutics

Countries where clinical trial is conducted

Ireland,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. up to 10 weeks
Secondary 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. up to 10 weeks
Secondary 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. up to 10 weeks
Secondary 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. up to 10 weeks
Secondary Incidence of treatment-emergent adverse events (TEAEs) Type and rates of adverse events up to 10 weeks
See also
  Status Clinical Trial Phase
Recruiting NCT05915013 - Alpha-Amino-3-Hydroxy-5-Methyl-4- Isoxazole Propionic Acid Receptor Components of the Anti-Depressant Ketamine Response Phase 1
Recruiting NCT05563805 - Exploring Virtual Reality Adventure Training Exergaming N/A
Recruiting NCT05934162 - Efficacy of Internet-delivered Cognitive-behavior Therapy for PTSD N/A
Recruiting NCT05934175 - Intensive Treatment Versus Standard Weekly Prolonged Exposure for Adults With Post-Traumatic Stress Disorder N/A
Completed NCT04460014 - Simple Cognitive Task Intervention After Trauma During COVID-19 In Hospital Staff EKUT-P RCT N/A
Completed NCT05877807 - Effect of Baclofen to Prevent Post-Traumatic Stress Disorder
Active, not recruiting NCT05992649 - The Effect of Aquatic Physiotherapy on Veterans Suffering From PTSD - a 40-week Pilotproject N/A
Terminated NCT04404712 - FAAH Availability in Psychiatric Disorders: A PET Study Early Phase 1
Not yet recruiting NCT05331534 - Effect of Attentional Therapy on Post-traumatic Stress Disorder N/A
Not yet recruiting NCT04076215 - Biochemical and Physiological Response to Stressogenic Stimuli N/A
Not yet recruiting NCT03649607 - Accelerated Resolution Therapy for HIV Positive African, Caribbean and Black N/A
Not yet recruiting NCT02545192 - A Pilot Study of Low Field Magnetic Stimulation in PTSD: Three Daily Treatments Phase 1
Completed NCT02329418 - Written Document to Assist Family During Decision of Withholding and Withdrawing Life-sustaining Therapies in the Intensive Care Unit N/A
Active, not recruiting NCT00978484 - A Head-to-head Comparison of Virtual Reality Treatment for Post Traumatic Stress Disorder Phase 3
Completed NCT00760734 - Hyperbaric Oxygen Therapy (HBOT) in Chronic Traumatic Brain Injury (TBI)/Post Concussion Syndrome (PCS) and TBI/Post-Traumatic Stress Disorder (PTSD) Phase 1
Completed NCT03278171 - Early Detection of Patients at Risk of Developing a Post-traumatic Stress Disorder After a Stay in Intensive Care Unit
Recruiting NCT05874362 - People Bereaved by Violent Death : Negative Event Biases and Temporal Perception N/A
Terminated NCT03898843 - Assisted Animal Therapy: ReAnimal N/A
Recruiting NCT04747379 - Psychological Effect of Explicit Recall After Sedation (PEERS)
Completed NCT03248167 - Cannabidiol as a Treatment for AUD Comorbid With PTSD Phase 1/Phase 2