NCT07670702

Brief Summary

This study is evaluating the long-term safety and efficacy of TSND-201 in adults with PTSD. Participants that have completed a double-blind clinical trial with TNSD-201 for PTSD will be invited to participate in this open-label extension trial. Each participant will be able to receive up to three Treatment Courses over the duration of the study (up to 48 weeks). Each Treatment Course includes 4 dosing sessions, spaced one week apart.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P50-P75 for phase_3

Timeline
30mo left

Started Jun 2026

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress7%
Jun 2026Jan 2029

Study Start

First participant enrolled

June 1, 2026

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

June 19, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 26, 2026

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2029

Last Updated

June 26, 2026

Status Verified

June 1, 2026

Enrollment Period

2.5 years

First QC Date

June 19, 2026

Last Update Submit

June 19, 2026

Conditions

Post Traumatic Stress Disorder

Keywords

PTSDEMPOWER-EXTTranscend TherapeuticsTSND-201Neuroplastogen

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline in Clinician-Administered PTSD Scale for 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 48 weeks

Study Arms (1)

TSND-201

EXPERIMENTAL
Drug: TSND-201

Interventions

TSND-201DRUG

TSND-201 capsules, given orally; where a course of treatment includes dosing with TSND-201 once a week for four consecutive weeks

TSND-201

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Completion of a double-blind Transcend-sponsored clinical trial with TSND-201 (e.g., TSND201-PTSD-301) and considered in good standing with the study site.
  • Proficient in communication (verbal and reading) to complete interviews and written questionnaires.
  • Agree to not participate in any other interventional clinical trials for the duration of this study.

You may not qualify if:

  • Experienced an intolerable side effect following dosing with TSND-201 in the prior study.
  • Had significant deviation(s)/non-compliance in parent study in the opinion of the Investigator which would deem them unsuitable for participation.
  • Change or development of any physical or psychological finding that would make participant unsuitable for study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CNS Healthcare

Orlando, Florida, 32801, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2026

First Posted

June 26, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

January 1, 2029

Last Updated

June 26, 2026

Record last verified: 2026-06

Locations

US(1)