An Evaluation of the Safety and Efficacy of an Investigational Medicine for the Treatment of PTSD (IMPACT-2)

RECRUITMENT FOR STUDY

SPONSORED BY TRANSCEND THERAPEUTICS

Sunstone is recruiting participants for a randomized study to evaluate the safety and efficacy of an investigational medicine 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 impacts an individual’s relationships, cognitive and psychosocial functioning, and overall quality of life. Although numerous therapeutic approaches including the use of antidepressant medications exist for addressing PTSD, current treatments are insufficient.

TSND-201 is a rapid acting neuroplastogen with no hallucinogenic properties. This research seeks to continue exploring the therapeutic value of this type of treatment.

Purpose and Description

The purpose of this study is to investigate the safety and efficacy of three dose levels of TSND-201 in adults with PTSD.


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

  • Screening Period
  • Preparatory Session
  • Four (4) Dosing Sessions
  • Check-in appointments in between dosing sessions
  • Follow-Up Period until 8 weeks post-final dose

Important Considerations

  • The study’s procedures and therapy are at no cost to the participant. Eligible participants are compensated with a stipend at every visit.
  • Eligible participants will be randomized in a 1:1:1 ratio to receive one of three dose levels. All participants will receive active study drug.
  • All in person visits take place at Sunstone Therapies. Some study visits can be completed remotely.
  • TSND-201 will be administered in a safe setting with support from trained and experienced therapists.  TSND-201 effects are typically temporary, and safety is continually monitored.
  • Participants may be asked to refrain from taking any psychiatric medications or interventions during the study, unless indicated by the Site Investigator. No participant will be asked to discontinue potentially beneficial treatment in order to participate in this study.
  • Participants should not be pregnant, nursing or planning a pregnancy, and must agree to use a highly effective method of birth control during the entire course of the clinical trial.
  • Risks to participation will be reviewed extensively during the screening and informed consent process.

To inquire about participation in the Transcend IMPACT-2 study, apply below:

Apply For The Study

For more information about the study: https://clinicaltrials.gov/study/NCT06215261?term=TSND201-PTSD-202&rank=1