A Pilot Study to Assess the Use of a New Investigational Oral Medication for Individuals with PTSD

RECRUITMENT FOR STUDY

Sunstone is recruiting participants for a new multi-center study to evaluate the safety and effectiveness of an investigational oral medication in adults with Post-Traumatic Stress Disorder (PTSD).

Introduction and Rationale for Study

Post-traumatic stress disorder (PTSD) is a debilitating and serious health condition that can impact an individual’s relationships, cognitive and psychosocial functioning, and overall quality of life. Although numerous therapeutic approaches exist, including the use of FDA-approved medications for PTSD, current treatments may not be sufficient for everyone.

This investigational medication may create a sense of emotional openness, reduced fear, and increased understanding of feelings. This research seeks to continue exploring the safety and effectiveness of this type of investigational medication for the potential treatment of PTSD.

Purpose and Description

The purpose of this study is to investigate the safety and effectiveness of an investigational oral medication in adults with PTSD.

The study is estimated to be 16 weeks from screening to end of study:

  • Screening Period
  • Preparatory Session
  • 4 Dosing Sessions
  • Follow-Up Period until 6 weeks post-final dose

Important Considerations

  • The study’s procedures are provided at no cost to you.
  • Eligible participants will be randomly assigned by chance (like the flip of a coin; 1 in 2 or 50% chance) to receive either the investigational medication or placebo. A placebo looks like the active investigational medication but contains no active ingredients. (i.e., :sugar pill”).
  • All in person visits take place at The Bill Richards Center for Healing, Aquilino Cancer Center, 9905 Medical Center Drive, Rockville, MD.
  • The investigational medication will be administered in a safe setting with support from trained and experienced research staff. Effects of the medication are typically temporary, and safety is continually monitored.
  • During the screening visit, you will undergo testing including discussion of how your symptoms of PTSD are impacting your life to ensure you qualify for the study. You will not be asked to discontinue potentially beneficial treatment in order to participate in this study.
  • You should not be pregnant, nursing or planning a pregnancy, and must agree to use a highly effective method of contraception during the entire course of the clinical trial.
  • Risks to participation will be reviewed extensively during the screening and informed consent process.

Potential benefit of participation

There may not be any benefit to participants; but you are contributing to the scientific knowledge which may lead to the expansion of treatment options for people with PTSD. Participation is also completely voluntary and you may leave the study at any time.

To inquire about participation in the Transcend TT-TSND-201 Study, apply below:

Apply For The Study

For more information about the study: https://clinicaltrials.gov/ct2/show/NCT05584826