Questions and Answers
No new health data that identifies you will be gathered after your written request is received.
True
You can access your health data in the study records during the study.
False
What happens to health data that has already been gathered during the study?
It may still be used and given to others as described in the form.
Participants are required to sign the form to take part in the study.
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I voluntarily agree to allow study staff to collect, use and share my health data as specified in this form. I will receive a signed and dated copy of this form for my ___.
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What will be given to you at the end of the study?
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What types of samples will be collected during the study?
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Will genetic testing be conducted in this study?
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What should participants do regarding their current medications before the study?
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Participants must use very effective ______ during the study.
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Participants are required to refrain from drinking alcohol for how long prior to screening and dosing sessions?
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What is the total compensation for participating in the study?
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Participants can withdraw from the study without any consequences.
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What might happen if a participant does not provide their identification data?
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If a participant is injured as a result of the study drug, the Sponsor will pay for medical expenses that are not covered by ______.
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What is the purpose of this study?
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Who is the principal investigator of the study?
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What will participants receive during Part A of the study?
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Methylone is an approved treatment by the US Food and Drug Administration (FDA) for PTSD.
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How many study visits are required throughout the study?
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What is a placebo?
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Participants may feel pressured into joining the study.
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What will be monitored throughout the study to ensure participant safety?
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What should participants do if they experience side effects?
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What age range do participants need to be in to qualify for this study?
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Participants will attend the clinic for study treatment once a week for ___ weeks.
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Study Notes
Study Overview
- Conducted by Transcend Therapeutics, Inc. to evaluate methylone for PTSD treatment.
- Protocol Number: TSND201-PTSD-202.
- Principal Investigator: Rishi Kakar, M.D.
- Study comprises two parts: Part A (open-label, all participants receive methylone) and Part B (placebo-controlled).
Purpose of the Study
- Focused on assessing the safety and efficacy of methylone, a psychoactive compound similar to MDMA, for individuals with PTSD.
- Aims to explore methylone's potential benefits: emotional openness, reduced fear, and increased understanding of feelings.
Eligibility Criteria
- Participants must be adults aged 18 to 70 with a diagnosis of severe PTSD.
- Key condition: Symptoms must have persisted for at least 6 months prior to screening.
- Must not have responded to previous treatments, including SSRIs like sertraline or paroxetine.
Study Design
- Part A involves approximately 15 participants receiving methylone over three dosing sessions conducted weekly.
- Safety monitored by a Data Safety and Monitoring Board.
- Part B will consist of up to 64 participants, divided into methylone and placebo groups.
Key Procedures
- Screening involves comprehensive assessments: medical history, psychiatric evaluations, ECG, vital signs measurements.
- Blood and urine samples collected for health checks and drug screening.
- Control measures in place during dosing sessions, including psychological support from a Mentor.
Side Effects and Monitoring
- Common side effects reported: headache (42.9%), decreased appetite (28.6%), and non-heart chest pain (21.4%).
- Serious potential side effects may include psychological distress, hallucinations, and allergic reactions.
- Continuous monitoring of heart rate, blood pressure, and body temperature during sessions.
Participant Rights
- Participation is voluntary; individuals may withdraw without penalty.
- Alternative treatment options available, such as therapy or other medications.
Emergency Procedures
- Participants provided with contact information for study staff for urgent concerns.
- Emergency protocols in place to address any severe health complications during the study.
Duration and Follow-up
- Total study duration: up to 13 weeks, including screening, treatment, and follow-up.
- At least 7 on-site visits required, with potential remote sessions for assessments.### Study Overview
- A mental health specialist (Mentor) will provide guidance on feelings experienced following study drug administration.
- PTSD symptom severity will be assessed through a videoconference with an independent clinician and recorded for training.
Initial Assessments
- Participants will complete questionnaires regarding PTSD symptoms, mood, and sleep quality.
- Vital signs including blood pressure, heart rate, respiratory rate, and temperature will be measured.
- Urine tests will screen for drug abuse.
Study Treatment Sessions
- Dosing sessions occur on Days 1, 8, and 15, lasting approximately 8 to 9 hours.
- Participants must fast for 2 hours before and after taking the study drug.
- Alcohol consumption should be avoided 24 hours prior to visits; caffeine and xanthine are restricted 2 hours before dosing.
- Female participants will undergo a urine pregnancy test prior to dosing.
- The Mentor will provide support during dosing sessions, which will be recorded for verification.
- Participants are required to stay at the clinic for at least 8 hours post-dosing or until effects have dissipated.
Follow-Up Protocol
- Participants will receive a check-in call the day after each dosing session.
- A follow-up visit is scheduled two days after each dosing session for health assessments and questionnaires.
- Additional follow-ups include visits one week, two weeks, three weeks, four weeks, and six weeks post final treatment, each involving symptom assessments, vital checks, and questionnaires.
Participant Responsibilities
- Attendance at all scheduled sessions is mandatory for participation.
- Prior to study involvement, all health history and current medications must be disclosed.
- Participants must refrain from new medications and significant lifestyle changes throughout the study.
Adverse Events and Reporting
- Any emotional distress or unusual experiences should be reported to study staff immediately.
- Regular assessments for overall health and potential side effects will be conducted at each visit.
Sample Collection
- Blood and urine samples will be taken at several points during the study, with a total of approximately 24 mL of blood collected over the study period.
- Genetic testing is not part of this study, and all samples will be analyzed and discarded post-analysis.
Contraceptive Requirements
- Highly effective contraception must be used throughout the study and for specified periods post-study to prevent potential harm to unborn children.
- Male participants must refrain from sperm donation for 90 days following the final dose.
Risks and Side Effects
- Potential side effects from blood draws include discomfort, irritation, or in rare cases, infection.
- Risks related to ECG include slight skin irritations from adhesive stickers.
- Psychological evaluations may cause distress; support will be available.
- Discontinuing antidepressants may lead to withdrawal symptoms, thus requiring careful monitoring.
Benefits of Participation
- Participation may not provide direct benefits, but contributes to research aiming to enhance treatment options for PTSD.
- Post-study treatment will not continue with the study drug, as it is not approved for general use.### Study Overview
- Research focuses on the drug methylone, particularly its repeated use and long-term safety, which remains unknown.
- Study aims to inform future research endeavors.
Participant Information
- New findings about the drug may arise during the study, necessitating communication with participants.
- Participants may consent to continued involvement even after new information comes to light.
- Participants can withdraw from the study anytime without facing consequences, but must inform the study doctor.
Withdrawal Circumstances
- The study doctor can withdraw a participant if deemed in their best interest, if they require prohibited medications, if pregnancy occurs, or if the study experience is poorly followed.
- Participants, even if withdrawn, may still be asked to continue monitoring.
Reporting Concerns
- Participants should promptly report any illness or injury occurring during the study to the study doctor.
- Medical expenses related to study-related injuries may be covered by the Sponsor, provided the necessary information is shared for Medicare checks.
Data Usage and Confidentiality
- Personal information collected includes name, demographics, and health history.
- Confidentiality efforts are made, but complete anonymity isn’t guaranteed.
- Data used by the study doctor, the Sponsor, FDA, and IRB to ensure proper research conduct.
Participant Rights
- Participants can stop their involvement without losing their legal rights or data.
- Participants do not have access to change their personal data held by the study for reliability purposes.
- Healthcare providers may be informed about participant involvement.
Participation and Compensation
- No costs incurred by participants for study involvement or procedures.
- Total compensation for participation can amount up to $3,415, detailed by visit schedules.
- Unscheduled visits may provide additional stipends and transportation services may be available.
Results and Publication
- Study data will be anonymous in any reports or publications.
- Results may help future PTSD research and will be publicly accessible after completion.
- Clinical trial details will be available on the ClinicalTrials.gov website.
Informed Consent Process
- Recording of dosing sessions for training purposes is mandatory.
- Participants must acknowledge understanding of consent information and confirm their voluntary participation.
- Emergency contact guidelines provided for participants to report any health-related issues.
Data Sharing Authorization
- Health data may be shared with authorized users, including study representatives and regulatory bodies.
- Use of health data will support study integrity, evaluating drug efficacy and safety.
- Participants may revoke consent for data sharing at any time, ending the authorization after 50 years unless revoked sooner.
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Description
Informed consent form for a clinical trial evaluating the safety and efficacy of Methylone for PTSD treatment. Participants must read and understand the terms before proceeding.
